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Figure 1.
Consolidated Standards of Reporting Trials (CONSORT) Diagram
Consolidated Standards of Reporting Trials (CONSORT) Diagram

GBT indicates group-administered behavioral treatment; UI, urinary incontinence; and UTI, urinary tract infection.

Figure 2.
Changes in the ICIQ-SF Scores Over Time by Treatment Group
Changes in the ICIQ-SF Scores Over Time by Treatment Group

GBT indicates group-administered behavioral treatment; ICIQ-SF, International Consultation on Incontinence Questionnaire–Short Form (score range, 0-21; higher scores indicate greater severity of urinary incontinence).

Table 1.  
Demographic and Clinical Characteristics of the Sample
Demographic and Clinical Characteristics of the Sample
Table 2.  
Secondary and Cost Outcomes
Secondary and Cost Outcomes
1.
Dumoulin  C, Adewuyi  T, Booth  J,  et al. Adult conservative management. In: Abrams  P, Cardozo  L, Wagg  A, Wein  A, eds.  Incontinence: 6th International Consultation on Incontinence. Bristol, UK: ICI-ICS (International Continence Society); 2017:1443-1628.
2.
Coyne  KS, Wein  A, Nicholson  S, Kvasz  M, Chen  CI, Milsom  I.  Economic burden of urgency urinary incontinence in the United States: a systematic review.  J Manag Care Pharm. 2014;20(2):130-140.PubMedGoogle Scholar
3.
Qaseem  A, Dallas  P, Forciea  MA, Starkey  M, Denberg  TD, Shekelle  P; Clinical Guidelines Committee of the American College of Physicians.  Nonsurgical management of urinary incontinence in women: a clinical practice guideline from the American College of Physicians.  Ann Intern Med. 2014;161(6):429-440. doi:10.7326/M13-2410PubMedGoogle ScholarCrossref
4.
Bø  K, Haakstad  LA.  Is pelvic floor muscle training effective when taught in a general fitness class in pregnancy? a randomised controlled trial.  Physiotherapy. 2011;97(3):190-195. doi:10.1016/j.physio.2010.08.014PubMedGoogle ScholarCrossref
5.
Pelaez  M, Gonzalez-Cerron  S, Montejo  R, Barakat  R.  Pelvic floor muscle training included in a pregnancy exercise program is effective in primary prevention of urinary incontinence: a randomized controlled trial.  Neurourol Urodyn. 2014;33(1):67-71. doi:10.1002/nau.22381PubMedGoogle ScholarCrossref
6.
Hilde  G, Stær-Jensen  J, Siafarikas  F, Ellström Engh  M, Bø  K.  Postpartum pelvic floor muscle training and urinary incontinence: a randomized controlled trial  [published correction appears in Obstet Gynecol. 2014;124(3):639].  Obstet Gynecol. 2013;122(6):1231-1238. doi:10.1097/AOG.0000000000000012PubMedGoogle ScholarCrossref
7.
Alves  FK, Riccetto  C, Adami  DB,  et al.  A pelvic floor muscle training program in postmenopausal women: a randomized controlled trial.  Maturitas. 2015;81(2):300-305. doi:10.1016/j.maturitas.2015.03.006PubMedGoogle ScholarCrossref
8.
Dugan  SA, Lavender  MD, Hebert-Beirne  J, Brubaker  L.  A pelvic floor fitness program for older women with urinary symptoms: a feasibility study.  PM R. 2013;5(8):672-676. doi:10.1016/j.pmrj.2013.03.009PubMedGoogle ScholarCrossref
9.
Hill  L, Fereday-Smith  J, Credgington  C,  et al.  Bladders behaving badly, a randomized controlled trial of group versus individual interventions in the management of female urinary incontinence.  J Assoc Chart Physio Women’s Health. 2007;101:30-36.Google Scholar
10.
Pereira  VS, Correia  GN, Driusso  P.  Individual and group pelvic floor muscle training versus no treatment in female stress urinary incontinence: a randomized controlled pilot study.  Eur J Obstet Gynecol Reprod Biol. 2011;159(2):465-471. doi:10.1016/j.ejogrb.2011.09.003PubMedGoogle ScholarCrossref
11.
Lamb  SE, Pepper  J, Lall  R,  et al.  Group treatments for sensitive health care problems: a randomised controlled trial of group versus individual physiotherapy sessions for female urinary incontinence.  BMC Womens Health. 2009;9:26. doi:10.1186/1472-6874-9-26PubMedGoogle ScholarCrossref
12.
Bø  K, Hagen  RH, Kvarstein  B, Jorgensen  J, Larsen  S.  Pelvic floor muscle exercise for the treatment of female stress urinary incontinence, III: effects of two different degrees of pelvic floor muscle exercises.  Neurourol Urodyn. 1990;9:489-502. doi:10.1002/nau.1930090505Google ScholarCrossref
13.
Felicíssimo  MF, Carneiro  MM, Saleme  CS, Pinto  RZ, da Fonseca  AM, da Silva-Filho  AL.  Intensive supervised versus unsupervised pelvic floor muscle training for the treatment of stress urinary incontinence: a randomized comparative trial.  Int Urogynecol J. 2010;21(7):835-840. doi:10.1007/s00192-010-1125-1PubMedGoogle ScholarCrossref
14.
de Oliveira Camargo  F, Rodrigues  AM, Arruda  RM, Ferreira Sartori  MG, Girão  MJ, Castro  RA.  Pelvic floor muscle training in female stress urinary incontinence: comparison between group training and individual treatment using PERFECT assessment scheme.  Int Urogynecol J Pelvic Floor Dysfunct. 2009;20(12):1455-1462. doi:10.1007/s00192-009-0971-1PubMedGoogle ScholarCrossref
15.
Kim  H, Yoshida  H, Suzuki  T.  The effects of multidimensional exercise treatment on community-dwelling elderly Japanese women with stress, urge, and mixed urinary incontinence: a randomized controlled trial.  Int J Nurs Stud. 2011;48(10):1165-1172. doi:10.1016/j.ijnurstu.2011.02.016PubMedGoogle ScholarCrossref
16.
Janssen  CC, Lagro-Janssen  AL, Felling  AJ.  The effects of physiotherapy for female urinary incontinence: individual compared with group treatment.  BJU Int. 2001;87(3):201-206. doi:10.1046/j.1464-410x.2001.02040.xPubMedGoogle ScholarCrossref
17.
Tak  EC, van Hespen  A, van Dommelen  P, Hopman-Rock  M.  Does improved functional performance help to reduce urinary incontinence in institutionalized older women? a multicenter randomized clinical trial.  BMC Geriatr. 2012;12:51. doi:10.1186/1471-2318-12-51PubMedGoogle ScholarCrossref
18.
Diokno  AC, Sampselle  CM, Herzog  AR,  et al.  Prevention of urinary incontinence by behavioral modification program: a randomized, controlled trial among older women in the community.  J Urol. 2004;171(3):1165-1171. doi:10.1097/01.ju.0000111503.73803.c2PubMedGoogle ScholarCrossref
19.
Sampselle  CM, Newman  DK, Miller  JM,  et al.  A randomized controlled trial to compare 2 scalable interventions for lower urinary tract symptom prevention: main outcomes of the TULIP study.  J Urol. 2017;197(6):1480-1486. doi:10.1016/j.juro.2016.12.099PubMedGoogle ScholarCrossref
20.
Tannenbaum  C, Agnew  R, Benedetti  A, Thomas  D, van den Heuvel  E.  Effectiveness of continence promotion for older women via community organisations: a cluster randomised trial.  BMJ Open. 2013;3(12):e004135. doi:10.1136/bmjopen-2013-004135PubMedGoogle ScholarCrossref
21.
McFall  SL, Yerkes  AM, Cowan  LD.  Outcomes of a small group educational intervention for urinary incontinence: health-related quality of life.  J Aging Health. 2000;12(3):301-317. doi:10.1177/089826430001200302PubMedGoogle ScholarCrossref
22.
Diokno  AC, Ocampo  MS  Jr, Ibrahim  IA, Karl  CR, Lajiness  MJ, Hall  SA.  Group session teaching of behavioral modification program (BMP) for urinary incontinence: a randomized controlled trial among incontinent women.  Int Urol Nephrol. 2010;42(2):375-381. doi:10.1007/s11255-009-9626-xPubMedGoogle ScholarCrossref
23.
Messer  KL, Herzog  AR, Seng  JS,  et al.  Evaluation of a mass mailing recruitment strategy to obtain a community sample of women for a clinical trial of an incontinence prevention intervention.  Int Urol Nephrol. 2006;38(2):255-261. doi:10.1007/s11255-006-0018-1PubMedGoogle ScholarCrossref
24.
Avery  K, Donovan  J, Peters  TJ, Shaw  C, Gotoh  M, Abrams  P.  ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence.  Neurourol Urodyn. 2004;23(4):322-330. doi:10.1002/nau.20041PubMedGoogle ScholarCrossref
25.
Diokno  AC, Dimaculangan  RR, Lim  EU, Steinert  BW.  Office based criteria for predicting type II stress incontinence without further evaluation studies.  J Urol. 1999;161(4):1263-1267. doi:10.1016/S0022-5347(01)61652-5PubMedGoogle ScholarCrossref
26.
Patrick  DL, Martin  ML, Bushnell  DM, Yalcin  I, Wagner  TH, Buesching  DP.  Quality of life of women with urinary incontinence: further development of the Incontinence Quality of Life Instrument (I-QOL)  [published correction appears in Urology. 1999;53(5):1072].  Urology. 1999;53(1):71-76. doi:10.1016/S0090-4295(98)00454-3PubMedGoogle ScholarCrossref
27.
Brink  CA, Wells  TJ, Sampselle  CM, Taillie  ER, Mayer  R.  A digital test for pelvic muscle strength in women with urinary incontinence.  Nurs Res. 1994;43(6):352-356. doi:10.1097/00006199-199411000-00006PubMedGoogle ScholarCrossref
28.
Borson  S, Scanlan  JM, Watanabe  J, Tu  SP, Lessig  M.  Simplifying detection of cognitive impairment: comparison of the Mini-Cog and Mini-Mental State Examination in a multiethnic sample.  J Am Geriatr Soc. 2005;53(5):871-874. doi:10.1111/j.1532-5415.2005.53269.xPubMedGoogle ScholarCrossref
29.
Shumway-Cook  A, Brauer  S, Woollacott  M.  Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test.  Phys Ther. 2000;80(9):896-903.PubMedGoogle Scholar
30.
Miller  JM, Ashton-Miller  JA, Delancey  JO.  Quantification of cough-related urine loss using the paper towel test.  Obstet Gynecol. 1998;91(5, pt 1):705-709.PubMedGoogle Scholar
31.
Locher  JL, Goode  PS, Roth  DL, Worrell  RL, Burgio  KL.  Reliability assessment of the bladder diary for urinary incontinence in older women.  J Gerontol A Biol Sci Med Sci. 2001;56(1):M32-M35. doi:10.1093/gerona/56.1.M32PubMedGoogle ScholarCrossref
32.
Lose  G, Jørgensen  L, Thunedborg  P.  24-Hour home pad weighing test versus 1-hour ward test in the assessment of mild stress incontinence.  Acta Obstet Gynecol Scand. 1989;68(3):211-215. doi:10.3109/00016348909020991PubMedGoogle ScholarCrossref
33.
Burgio  KL, Locher  JL, Goode  PS,  et al.  Behavioral vs drug treatment for urge urinary incontinence in older women: a randomized controlled trial.  JAMA. 1998;280(23):1995-2000. doi:10.1001/jama.280.23.1995PubMedGoogle ScholarCrossref
34.
Yalcin  I, Bump  RC.  Validation of two global impression questionnaires for incontinence.  Am J Obstet Gynecol. 2003;189(1):98-101. doi:10.1067/mob.2003.379PubMedGoogle ScholarCrossref
35.
Bureau of Labor Statistics, US Department of Labor. May 2016 national occupational employment and wages estimates, United States. https://www.bls.gov/oes/2016/may/oes_nat.htm. Last modified March 31, 2017. Accessed January 2017.
36.
Subak  L, Van Den Eeden  S, Thom  D, Creasman  JM, Brown  JS; Reproductive Risks for Incontinence Study at Kaiser Research Group.  Urinary incontinence in women: Direct costs of routine care.  Am J Obstet Gynecol. 2007;197(6):596.e1-596.e9. doi:10.1016/j.ajog.2007.04.029PubMedGoogle ScholarCrossref
37.
Bureau of Labor Statistics, US Department of Labor. Table 3: median usual weekly earnings of full-time wage and salary workers by age, race, Hispanic or Latino ethnicity, and sex, not seasonally adjusted. https://www.bls.gov/webapps/legacy/cpswktab3.htm. Last modified September 16, 2015. Accessed January 2017.
38.
Nyström  E, Sjöström  M, Stenlund  H, Samuelsson  E.  ICIQ symptom and quality of life instruments measure clinically relevant improvements in women with stress urinary incontinence.  Neurourol Urodyn. 2015;34(8):747-751. doi:10.1002/nau.22657PubMedGoogle ScholarCrossref
39.
Yalcin  I, Peng  G, Viktrup  L, Bump  RC.  Reductions in stress urinary incontinence episodes: what is clinically important for women?  Neurourol Urodyn. 2010;29(3):344-347.PubMedGoogle Scholar
40.
Diokno  AC, Ogunyemi  T, Siadat  MR, Arslanturk  S, Killinger  KA.  Continence Index: a new screening questionnaire to predict the probability of future incontinence in older women in the community.  Int Urol Nephrol. 2015;47(7):1091-1097. doi:10.1007/s11255-015-1006-0PubMedGoogle ScholarCrossref
41.
Wagner  TH, Moore  KH, Subak  LL, deWatcher  S, Dudding  T. Economics of urinary and fecal incontinence and prolapse. In: Abrams P, Cardozo L, Wagg A, Wein A, eds.  Incontinence: 6th International Consultation on Incontinence. Bristol, UK: ICI-ICS (International Continence Society); 2017:2479-2511.
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    Original Investigation
    October 2018

    Effect of Group-Administered Behavioral Treatment on Urinary Incontinence in Older Women: A Randomized Clinical Trial

    Author Affiliations
    • 1Department of Urology, Beaumont Hospital, Royal Oak, Michigan
    • 2Division of Urology, Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia
    • 3Department of Health Behavior and Biological Sciences, University of Michigan School of Nursing, Ann Arbor
    • 4Department of Urology, University of Kansas School of Medicine, Kansas City
    • 5The Landon Center on Aging, University of Kansas School of Medicine, Kansas City
    • 6Department of Internal Medicine, Beaumont Hospital, Royal Oak, Michigan
    • 7Department of Medicine, University of Alabama at Birmingham
    • 8Birmingham/Atlanta Geriatric Research, Education, and Clinical Center, Department of Veterans Affairs, Birmingham, Alabama
    • 9Institute for Social Research, University of Michigan, Ann Arbor, Michigan
    • 10Department of Obstetrics and Gynecology, Stanford University, Palo Alto, California
    • 11Research Institute, Beaumont Hospital, Royal Oak, Michigan
    JAMA Intern Med. 2018;178(10):1333-1341. doi:10.1001/jamainternmed.2018.3766
    Key Points

    Question  What is the effect of a one-time, group-administered behavioral treatment on urinary incontinence in older women?

    Findings  In this multisite randomized clinical trial among 463 women 55 years or older, group-administered behavioral treatment showed statistically significant but clinically modest improvements at 3, 6, 9, and 12 months compared with control for urinary incontinence and all secondary outcomes except pelvic floor muscle strength. The incremental cost to achieve a treatment success was $723 at 3 months; group-administered behavioral treatment dominated at 12 months.

    Meaning  Group-administered behavioral treatment may be a promising first approach to enhancing access to noninvasive behavioral treatment for women with urinary incontinence.

    Abstract

    Importance  Urinary incontinence (UI) guidelines recommend behavioral interventions as first-line treatment using individualized approaches. A one-time, group-administered behavioral treatment (GBT) could enhance access to behavioral treatment.

    Objective  To compare the effectiveness, cost, and cost-effectiveness of GBT with no treatment for UI in older women.

    Design, Setting, and Participants  Multisite randomized clinical trial (the Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms [GLADIOLUS] study), conducted from July 7, 2014, to December 31, 2016. The setting was outpatient practices at 3 academic medical centers. Community-dwelling women 55 years or older with UI were recruited by mail and screened for eligibility, including a score of 3 or higher on the International Consultation on Incontinence Questionnaire–Short Form (ICIQ-SF), symptoms of at least 3 months’ duration, and absence of medical conditions or treatments that could affect continence status. Of 2171 mail respondents, 1125 were invited for clinical screening; 463 were eligible and randomized; 398 completed the 12-month study.

    Interventions  The GBT group received a one-time 2-hour bladder health class, supported by written materials and an audio CD.

    Main Outcomes and Measures  Outcomes were measured at in-person visits (at 3 and 12 months) and by mail or telephone (at 6 and 9 months). The primary outcome was the change in the ICIQ-SF score. Secondary outcome measures assessed UI severity, quality of life, perceptions of improvement, pelvic floor muscle strength, and costs. Evaluators were masked to group assignment.

    Results  Participants (232 in the GBT group and 231 in the control group) were aged 55 to 91 years (mean [SD] age, 64 [7] years), and 46.2% (214 of 463) were African American. In intent-to-treat analyses, the ICIQ-SF scores for GBT were consistently lower than control across all time points but did not achieve the projected 3-point difference. At 3 months, the difference in differences was 0.96 points (95% CI, −1.51 to −0.41 points), which was statistically significant but clinically modest. The mean (SE) treatment effects at 6, 9, and 12 months were 1.36 (0.32), 2.13 (0.33), and 1.77 (0.31), respectively. Significant group differences were found at all time points in favor of GBT on all secondary outcomes except pelvic floor muscle strength. The incremental cost to achieve a treatment success was $723 at 3 months; GBT dominated at 12 months.

    Conclusions and Relevance  The GLADIOLUS study shows that a novel one-time GBT program is modestly effective and cost-effective for reducing UI frequency, severity, and bother and improving quality of life. Group-administered behavioral treatment is a promising first-line approach to enhancing access to noninvasive behavioral treatment for older women with UI.

    Trial Registration  ClinicalTrials.gov identifier: NCT02001714

    Introduction

    Urinary incontinence (UI) is a prevalent condition that diminishes quality of life among older women at tremendous social and economic cost.1,2 Although there are several options available for treating UI, behavioral interventions are recommended by most evidence-based guidelines as first-line approach for treating urgency, stress, and mixed UI.3 Behavioral treatments can be delivered individually or in groups. Although individualized behavioral treatment programs have been studied extensively, demonstrating safety and effectiveness in patients with UI,1 these programs are sometimes met with resistance because they usually require multiple in-person visits and specialized health care professionals to teach and maintain the techniques.

    For decades, pelvic floor muscle (PFM) training has been integrated into education and fitness classes to promote pelvic health during pregnancy and the postpartum period and to prevent future symptoms.4-6 Group modalities have also been used to deliver PFM training as a treatment for symptomatic women using general fitness programs or specific pelvic fitness classes.7-16 Most of these programs focus on building PFM strength and involve multiple sessions across weeks or months. Less common are programs that take a broader behavioral approach, teaching women about bladder function, toileting techniques, bladder training, or behavioral strategies for bladder control, as well as programs that convey these skills in a classroom setting rather than in an exercise class.17-22

    Although research on such bladder health classes is limited, early work shows that they can be effective for preventing UI in older women18-20 and demonstrates encouraging results for decreasing UI symptoms and micturition frequency.21,22 The objective of the Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms (GLADIOLUS) study (trial protocol in Supplement 1), conducted from July 7, 2014, to December 31, 2016, was to evaluate the effectiveness, cost, and cost-effectiveness of a single 2-hour bladder health class to deliver an evidence-based behavioral treatment program supplemented with materials to guide home practice for older women with urgency, stress, or mixed UI. We hypothesized that group-administered behavioral treatment (GBT) would produce larger improvements in UI compared with no treatment.

    Methods

    This study was a randomized clinical trial conducted at 3 academic medical centers (University of Alabama at Birmingham; University of Michigan, Ann Arbor; and University of Pennsylvania, Philadelphia). It was approved by the institutional review boards at the coordinating center (Beaumont Hospital, Royal Oak, Michigan) and each site. All participants provided written informed consent.

    Recruitment

    We recruited potential participants by mailed letters of invitation to specific populations in the geographical areas surrounding the 3 sites. We purchased mailing lists of women 55 years or older living in targeted counties or communities from InfoUSA, Inc of Omaha, Nebraska.23 Mailing lists were customized for distribution to each of the 3 areas using variables that included zip codes, counties, radius, and race/ethnicity. Interested individuals could mail back a return portion of the recruitment letter or call a toll-free number.

    Evaluation and Baseline Assessment

    Women who responded to the letter of invitation were initially prescreened by telephone at the coordinating center and then referred to the appropriate research site for full screening and evaluation. This comprised a detailed medical and UI history and baseline questionnaires, including the primary outcome measure (the International Consultation on Incontinence Questionnaire–Short Form [ICIQ-SF]24) and secondary outcome measures (the Medical, Epidemiologic and Social Aspects of Aging Urinary Incontinence Questionnaire [MESA]25 and the Incontinence Quality of Life Questionnaire [I-QOL]).26 Pelvic examination was conducted to identify pelvic organ prolapse and test PFM strength using the digital test by Brink et al.27 Participants were tested for cognitive impairment using the Mini-Cog28 and for ambulation status using the Timed Up & Go test,29 and a dipstick urinalysis was performed to detect infection and hematuria. Baseline tests included a quantitative cough stress test,30 3-day voiding diary,31 and a 24-hour pad test.32 Inclusion and exclusion criteria are listed in the Box.

    Box Section Ref ID
    Box.

    Inclusion and Exclusion Criteria

    Inclusion Criteria
    • Female

    • Age ≥55 years

    • Ability to read and understand English

    • Score of ≥3 on the International Consultation on Incontinence Questionnaire–Short Form, with frequency of leakage a score of ≥1 (“about once a week or less often”) on item 1 and volume of urine loss a score of ≥2 (“a small amount”) on item 2

    • Self-reported urgency, stress, or mixed incontinence

    • Symptoms ≥3-month duration

    • Timed Up & Go test ≤20 seconds

    • No cognitive impairment (Mini-Cog)

    • Willingness to undergo pelvic examination

    • Signed informed consent form

    Exclusion Criteria
    • Nonambulatory (participant confined to bed or wheelchair)

    • History of bladder, renal, or uterine cancer

    • Unstable medical condition (as determined by principal investigator)

    • Daily pelvic pain >3-month duration

    • Known history of neurological or end-stage diseases (eg, stroke, Parkinson disease, multiple sclerosis, epilepsy, spinal cord tumor or trauma, spina bifida, or symptomatic herniated disk)

    • Previous treatment for urinary incontinence or pelvic organ prolapse

    • Current medication for incontinence or overactive bladder

    • Currently using a vaginal pessary

    • Other urinary conditions or procedures that may affect continence status (eg, urethral diverticula, previous augmentation cystoplasty or artificial urinary sphincter, or implanted nerve stimulators for urinary symptoms)

    • Pelvic organ prolapse past the introitus

    • Evidence of urinary tract infection by dipstick urinalysis

    • History of ≥2 urinary tract infections within the past year or >1 urinary tract infection within the past 6 months

    • Postvoid residual urine volume ≥150 mL

    Randomization

    Eligible women were randomized using a 1:1 ratio to either the GBT group or no treatment (control group). Randomization was carried out separately at each site using a random sequence of block sizes of 2, 4, 6, and 8, with a random assignment of 2 arms within each block to conceal allocation. The randomization scheme was developed by the coordinating center, and the research sites were not aware of the methods used to assign groups.

    Intervention

    The control group did not receive treatment. However, they were informed that they could receive the GBT class and materials or be referred to an incontinence specialist at the end of the study (12 months).

    The GBT was modeled after previously successful randomized clinical trials on prevention of UI18,19 but focused instead on treatment of women with UI.22 This 2-hour bladder health and self-management session, with slide presentations and a booklet, included the following elements: anatomy of the lower urinary tract; bladder and PFM function; anatomic and physiologic basis for continence; types, causes, and effect of UI on quality of life; PFM identification and exercise; bladder training; instruction in evidence-based behavioral strategies, including active PFM contraction during activities that precipitate stress UI and urge suppression strategies18,19,22,33; and coaching to facilitate incorporation of the strategies into their personal routines. After the class, participants were given materials for home use, including a booklet summarizing the bladder health class, a magnet that served as a reminder to continue adherence, an audio CD with a PFM exercise session, and an individualized voiding interval prescription based on their baseline 3-day voiding diary.

    To ensure competent and standardized delivery of the treatment, interventionists received a 1-day training. They were certified after role-play demonstrations of the critical components of the intervention. To further ensure consistency of the GBT protocol, all GBT sessions were recorded, and random samples of 11% were reviewed by one of us (T.L.G.) who was not a research site investigator.

    Outcome Measures and Evaluation Periods

    The primary outcome measure was the change in score on the ICIQ-SF,24 a fully validated 4-item questionnaire (correlated with the 24-hour pad test [r = 0.68] and the Patient Global Impression of Improvement [PGI-I]34 [r = 0.79]). Secondary outcome measures included a 3-day voiding diary, the quantitative cough stress test, the 24-hour pad test, the MESA (15 items, with test-retest reliability of 0.89 and agreement with clinician assessment of 87%), the PFM digital assessment by Brink et al,27 the I-QOL (22 items, with an internal consistency of 0.87-0.93 and a reproducibility intraclass correlation coefficient of 0.80-0.91), and the PGI-I. All participants were evaluated at in-person visits at 3 and 12 months by evaluators (D.K.N. and other nonauthors) who were masked to group assignment and by mail or telephone at 6 and 9 months. Adverse events (AEs) were also assessed at each time point.

    Costs and cost-effectiveness were assessed from the payer, participant, and societal perspectives. Payer costs were calculated by summing intervention materials (local rates) and labor (market value).35 Participant-incurred costs for incontinence management (eg, absorbent products and laundry) were estimated by self-reported resource use on the Incontinence Resource Use Questionnaire (IRUQ) and self-reported travel distance to the GBT class and were multiplied by the nationally generalizable unit cost (in 2017 US dollars).36 Indirect costs included participant time to attend the group session (age- and sex-specific wage rates).37

    Statistical Analysis

    Sample size determination was based on detecting a difference of 3 points in our primary outcome measure, the ICIQ-SF score, with a minimally important difference identified as 2.5 points.38 Based on the literature, we estimated the SD for the control population to be 6.8. We set the significance level to .05 and power at 90% for 2-sided comparison using a 2-sample t test. We also assumed a 25% dropout rate at 3 months and a 35% dropout rate at 12 months. Based on this power analysis, we projected a target sample size of at least 165 completed participants for each group.

    This was an intent-to-treat analysis with all randomized participants included. Missing data remained missing and were not replaced. Normally distributed continuous variables are reported as mean (SD) values. Nonnormally distributed variables are reported as median values (interquartile ranges).

    The primary outcome, the ICIQ-SF score, was analyzed using a repeated-measures analysis with a dummy variable for the treatment group; dummy variables for 3, 6, 9, and 12 months (baseline as reference); and the treatment × time interaction term as independent variables. The unstructured (5 × 5) covariance matrix was used for the residuals. The point estimates of the regression coefficients and their covariance matrices were used to construct inferences for 3 estimates of interest (namely, the baseline to 3-month difference for each group and the difference between the 2 groups). Both covariate-adjusted analysis and covariate-unadjusted analysis were performed. Given the balance of covariates between the 2 groups, the adjusted and unadjusted results were similar. The unadjusted results are reported. A maximum likelihood approach was used to construct point and interval estimates. The scores at each time point were also examined with Wilcoxon rank sum tests to assess the robustness of the results to the deviation from normality assumption. The analyses using the mean and median values were similar.

    Secondary outcome scores were examined at each time point with Wilcoxon rank sum tests for the continuous variables and with Pearson χ2 tests for the individual categorical questions if appropriate (expected frequencies >5 in 80% of cells). Fisher exact tests were used otherwise. Using Pearson χ2 tests, we examined AEs and serious AEs (SAEs) separately.

    Within-trial per capita costs from the payer, participant, and societal perspectives were compared between groups using Wilcoxon rank sum tests. Incremental cost-effectiveness ratios were estimated as the incremental cost divided by the incremental number of successes for GBT compared with control, with success defined as (1) a 70% reduction in UI episode frequency39 and (2) a 3-point decrease in the ICIQ-SF score from baseline. In total, 10 000 bootstrap samples were drawn to construct 95% bias-corrected CIs.

    Results

    A total of 463 participants were enrolled from 2171 initial mail respondents; 232 were randomized to GBT and 231 to control. Thirty-four of 463 participants (7.3%) withdrew, 22 in GBT (9.5%) and 12 (5.2%) in control (Figure 1); 398 completed the 12-month study.

    Characteristics of the Sample

    The demographic characteristics of the 2 groups were not significantly different. Ages ranged from 55 to 91 years (mean [SD] age, 64 [7] years), and African Americans comprised 46.2% (214 of 463) (Table 1). No significant differences were found between the 2 groups for all baseline values on primary and secondary outcome measures.

    Primary Outcome

    Figure 2 shows the descriptive statistics and change across 5 time points on the ICIQ-SF by treatment group. The overall F score for the treatment × time interaction term was significant (F4460 = 11.62, P < .001). At 3 months, there was a mean 1.94-point reduction (95% CI, −2.33 to −1.55 points) in the GBT group and a mean 0.98-point reduction (95% CI, −1.37 to −0.59 points) in the control group. Therefore, the difference in differences was 0.96 points (95% CI, −1.51 to −0.41 points), which was statistically significant but clinically modest.

    As shown in Figure 2, the ICIQ-SF scores for the GBT group were consistently lower compared with the control group across all time points. For example, the mean (SE) treatment effects at 6, 9, and 12 months were 1.36 (0.32), 2.13 (0.33), and 1.77 (0.31), respectively.

    The median score reductions on the ICIQ-SF were 1 point greater for the GBT group than for the control group at 3 months, 2 points greater at 6 and 9 months, and 1 point greater at 12 months, not achieving the projected 3-point difference. Few women, 4.1% (8 of 196) in the GBT group and 1.5% (3 of 203) in the control group, were totally dry (defined as 0 on the ICIQ-SF). Percentage changes in UI episodes based on the 3-day voiding diary were 41.1% for the GBT group vs 5.7% for the control group (P < .001), and the percentages of women who were considered successful (a 70% reduction in UI episode frequency) were 35.3% (65 of 184) in the GBT group vs 22.1% (42 of 190) in the control group (P = .005).

    Secondary Outcomes

    All secondary outcome measures (Table 2) except PFM strength showed significantly greater improvements in the GBT group than in the control group. For the 3-day voiding diary, the median number of daily voids and UI episodes per day were significantly lower for the GBT group than for the control group at 3, 6, 9, and 12 months. For the 24-hour pad test, the change in urine volume loss was a significantly greater reduction for the GBT group than for the control group at 3 and 12 months. The MESA urge and stress symptom scores were significantly lower for the GBT group than for the control group at 3 and 12 months. For the I-QOL, the GBT group had significantly higher median scores on quality of life compared with the control group at 3 and 12 months. Similarly, for the PGI-I, the GBT group had a significantly greater proportion of women reporting that they were “much better” or “very much better” compared with the control group at 3 and 12 months. Likewise, only 9.7% (19 of 196) of GBT respondents compared with 71.9% (146 of 203) of control respondents reported no change or worse. Regarding patient satisfaction (GBT participants only), 55.9% (118 of 211) and 61.2% (120 of 195), respectively, were “completely satisfied” at 3 months and 6 months, and only 4.7% (10 of 211) and 4.6% (9 of 195) were either “not at all satisfied” or “dissatisfied.” There were no significant differences between the groups at 3 and 12 months on the PFM digital assessment for strength.27

    Costs and Cost-effectiveness

    The GBT group accrued higher payer and societal costs per participant compared with the control group at 3 and 12 months (Table 2 and eTable 1 in Supplement 2). Participant costs, a subset of societal cost, were lower for the GBT group than for the control group at 3 and 12 months because of the lower costs of UI management. The incremental cost per treatment success for the GBT group vs the control group was low at the 3-month evaluation for both the 3-point reduction in the ICIQ-SF score and the 70% reduction in UI episode frequency ($723 and $637, respectively) and was lower at the longer time horizon of 6 months ($268 and $224, respectively), and the GBT group dominated at 12 months (both more effective and less costly by $21 and $17, respectively).

    AEs and SAEs

    No evidence was found for any differences in frequency of AEs and SAEs between groups. None of the SAEs were attributed to the study. Details are listed in eTable 2 in Supplement 2.

    Discussion

    This multisite randomized clinical trial in a racially/ethnically diverse sample demonstrated that a one-time GBT session was safe and cost-effective for reducing UI frequency, severity, and bother and improving quality of life for older women with UI when provided by trained interventionists. Improvements in the primary outcome measure were smaller than anticipated, as were the modest between-group differences, which, despite being statistically significant, did not reach the anticipated 3-point difference between groups. This can probably be attributed to the less intensive nature of the single-session group intervention compared with multiple visits to a health professional for individualized behavioral treatment or pharmaceutical or surgical treatment. In addition, the control group underwent the same baseline and follow-up assessments, including history taking, physical examination, 3-day voiding diary, 24-hour pad test, and questionnaires about their symptoms. It is possible that interacting with the research staff or completing the 3-day voiding diary or questionnaires could have enhanced their awareness of bladder symptoms and habits, resulting in increased vigilance and symptom improvements.

    Although improvements were modest in magnitude, an overall pattern was seen of significant between-group differences in improvement in UI episodes per day, the quantitative cough stress test, the 24-hour pad test, MESA scores, the I-QOL score, and the PGI-I. A minimally important difference of 2.5 on the ICIQ-SF38 was demonstrated at 9 and 12 months in the GBT group but not in the control group.

    This trial showed that health professionals can be trained to master and deliver an evidence-based behavioral treatment program to groups of older community-dwelling women. This noninvasive and inexpensive intervention could be implemented safely in a range of nonmedical settings. It may not represent a definitive intervention for all older women, but it could provide a safe and useful first-line approach that would be of benefit for many. If not fully successful, then the participants would be more informed about bladder problems and can seek other treatment options. In this sense, it could be the first step in a broader strategy to begin with the least invasive therapy and progress as needed to more intensive or invasive treatments.

    Because this standardized GBT protocol has been successfully used to prevent UI among continent older women living in the community,18,19 GBT community outreach programs could be considered not only for prevention but also for treatment of UI. One of the future areas to explore is to identify continent women who have a high potential for future UI using the recently developed Continence Index questionnaire,40 which, if successful, would avoid significant investment of time and effort in preventing UI in women who are at low to no risk of developing UI.

    Furthermore, although PFM identification and training are an important component of GBT, it does not appear that all women require digital palpation of the PFM to learn the skill needed to achieve improvement, a similar finding in an earlier prevention study.18 Knowledge of strategic and timely use of the PFM may be the essential components of bladder health education.

    Cost-effectiveness analyses showed that GBT was a cost-effective method to improve UI symptoms. It incurred low costs and resulted in sustained improvement in UI associated with decreased costs for UI management through 12 months. The cost-effectiveness ratios observed in this trial were low and similar to estimates in other behavioral incontinence interventions41 through 6 months, and the GBT group dominated the control group at 12 months, with lower cost and higher effectiveness.

    Strengths and Limitations

    A strength of this study was the recruitment approach. Using mass mailing, we were able to intentionally include zip codes that enhanced inclusion of African American participants, comprising 46.2% of the sample. Another goal of recruiting by mass mailing was to optimize generalizability by offering the opportunity of participation to community-dwelling women who may not have interacted previously with a health care professional for treatment of bladder problems. We recognize that, in seeking a sample broader than the usual clinical population, we might include women whose symptoms were milder.

    This trial has some limitations. First, participants and interventionists were not masked to group assignment, a common challenge to studies of behavioral interventions, which require active participation in the self-management strategies. However, the individuals conducting the outcome evaluations were masked to group assignment. Second, the participants were a volunteer sample and thus may not represent the overall population of older women with UI. Third, the primary and some secondary outcomes were based on participant self-report to assess changes in their condition. However, we strategically included more objective measures, such as the quantitative cough stress test and the 24-hour pad test, to complement the validated self-report measures, providing a more comprehensive assessment of outcomes.

    Conclusions

    The GLADIOLUS study shows that a novel one-time GBT program is a safe and modestly effective first-line approach for reducing UI frequency, severity, and bother and improving quality of life for older women in the community. With its low cost and ease of administration, GBT is a promising first approach to enhancing access to noninvasive behavioral treatment for UI.

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    Article Information

    Accepted for Publication: June 15, 2018.

    Corresponding Author: Kathryn L. Burgio, PhD, Department of Medicine, University of Alabama at Birmingham, 1530 Third Ave S, Birmingham, AL 35233 (kburgio@uabmc.edu).

    Published Online: September 4, 2018. doi:10.1001/jamainternmed.2018.3766

    Author Contributions: Dr Raghunathan and Ms Boura had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

    Concept and design: Diokno, Newman, Griebling, Maddens, Raghunathan, Subak, Sampselle, Burgio.

    Acquisition, analysis, or interpretation of data: Diokno, Newman, Low, Griebling, Goode, Raghunathan, Subak, Boura, Robinson, McIntyre, Burgio.

    Drafting of the manuscript: Diokno, Newman, Low, Griebling, Goode, Raghunathan, Subak, Robinson, McIntyre, Burgio.

    Critical revision of the manuscript for important intellectual content: Diokno, Newman, Low, Griebling, Maddens, Goode, Raghunathan, Subak, Sampselle, Boura, Burgio.

    Statistical analysis: Raghunathan, Subak, Boura.

    Obtained funding: Diokno, Newman, Subak, Sampselle, Burgio.

    Administrative, technical, or material support: Diokno, Low, Griebling, Maddens, Goode, Raghunathan, Subak, Sampselle, Robinson, McIntyre.

    Supervision: Newman, Low, Griebling, Goode, Raghunathan, Sampselle, Burgio.

    Conflict of Interest Disclosures: None reported.

    Funding/Support: This study was funded by grant R01AG043383 from the National Institute on Aging, National Institutes of Health.

    Role of the Funder/Sponsor: The funding source had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

    Disclaimer: The contents of this article do not represent the views of the US Department of Veterans Affairs or the US Government.

    Additional Contributions: We thank the following individuals for their role in the study: University of Alabama at Birmingham: Coordinators: Susan Barnacastle, BS, and Laurie Slay, CHES; Interventionist: R. Jeannine McCormick, MSN, CRNP; Evaluator: P. Ryanne Johnson, MSN, CRNP; and Data Entry: Lisa R. Allen, MPA, MPH, CHES. University of Michigan: Coordinator: Eileen Robinson, RN, MPH; Interventionist: Maria Militzer, MS; Evaluator: Kathy Rentenbach, MSN, WHNP; and Data Entry: Martha Davis-Merritts, BS. University of Pennsylvania: Coordinators and Data Entry: Rebecca Kimmel, BA, Alexandra Guardino, RN, BSN, Alexandra Magno, BS, and Hanna Stambakio, BS; Interventionist: MaryAnn DiCamillo, RN, BSN; and Evaluators: Mary Wang, DNP, CRNP, and Kristy Keyock, MSN, CRNP. Beaumont Coordinating Center: Data Management: Gloria Kopper, RN, MSA, Susan Gressa, RN, BSN, and Coleen Tessmar, RN. These individuals were compensated from grant funds through their salaries.

    References
    1.
    Dumoulin  C, Adewuyi  T, Booth  J,  et al. Adult conservative management. In: Abrams  P, Cardozo  L, Wagg  A, Wein  A, eds.  Incontinence: 6th International Consultation on Incontinence. Bristol, UK: ICI-ICS (International Continence Society); 2017:1443-1628.
    2.
    Coyne  KS, Wein  A, Nicholson  S, Kvasz  M, Chen  CI, Milsom  I.  Economic burden of urgency urinary incontinence in the United States: a systematic review.  J Manag Care Pharm. 2014;20(2):130-140.PubMedGoogle Scholar
    3.
    Qaseem  A, Dallas  P, Forciea  MA, Starkey  M, Denberg  TD, Shekelle  P; Clinical Guidelines Committee of the American College of Physicians.  Nonsurgical management of urinary incontinence in women: a clinical practice guideline from the American College of Physicians.  Ann Intern Med. 2014;161(6):429-440. doi:10.7326/M13-2410PubMedGoogle ScholarCrossref
    4.
    Bø  K, Haakstad  LA.  Is pelvic floor muscle training effective when taught in a general fitness class in pregnancy? a randomised controlled trial.  Physiotherapy. 2011;97(3):190-195. doi:10.1016/j.physio.2010.08.014PubMedGoogle ScholarCrossref
    5.
    Pelaez  M, Gonzalez-Cerron  S, Montejo  R, Barakat  R.  Pelvic floor muscle training included in a pregnancy exercise program is effective in primary prevention of urinary incontinence: a randomized controlled trial.  Neurourol Urodyn. 2014;33(1):67-71. doi:10.1002/nau.22381PubMedGoogle ScholarCrossref
    6.
    Hilde  G, Stær-Jensen  J, Siafarikas  F, Ellström Engh  M, Bø  K.  Postpartum pelvic floor muscle training and urinary incontinence: a randomized controlled trial  [published correction appears in Obstet Gynecol. 2014;124(3):639].  Obstet Gynecol. 2013;122(6):1231-1238. doi:10.1097/AOG.0000000000000012PubMedGoogle ScholarCrossref
    7.
    Alves  FK, Riccetto  C, Adami  DB,  et al.  A pelvic floor muscle training program in postmenopausal women: a randomized controlled trial.  Maturitas. 2015;81(2):300-305. doi:10.1016/j.maturitas.2015.03.006PubMedGoogle ScholarCrossref
    8.
    Dugan  SA, Lavender  MD, Hebert-Beirne  J, Brubaker  L.  A pelvic floor fitness program for older women with urinary symptoms: a feasibility study.  PM R. 2013;5(8):672-676. doi:10.1016/j.pmrj.2013.03.009PubMedGoogle ScholarCrossref
    9.
    Hill  L, Fereday-Smith  J, Credgington  C,  et al.  Bladders behaving badly, a randomized controlled trial of group versus individual interventions in the management of female urinary incontinence.  J Assoc Chart Physio Women’s Health. 2007;101:30-36.Google Scholar
    10.
    Pereira  VS, Correia  GN, Driusso  P.  Individual and group pelvic floor muscle training versus no treatment in female stress urinary incontinence: a randomized controlled pilot study.  Eur J Obstet Gynecol Reprod Biol. 2011;159(2):465-471. doi:10.1016/j.ejogrb.2011.09.003PubMedGoogle ScholarCrossref
    11.
    Lamb  SE, Pepper  J, Lall  R,  et al.  Group treatments for sensitive health care problems: a randomised controlled trial of group versus individual physiotherapy sessions for female urinary incontinence.  BMC Womens Health. 2009;9:26. doi:10.1186/1472-6874-9-26PubMedGoogle ScholarCrossref
    12.
    Bø  K, Hagen  RH, Kvarstein  B, Jorgensen  J, Larsen  S.  Pelvic floor muscle exercise for the treatment of female stress urinary incontinence, III: effects of two different degrees of pelvic floor muscle exercises.  Neurourol Urodyn. 1990;9:489-502. doi:10.1002/nau.1930090505Google ScholarCrossref
    13.
    Felicíssimo  MF, Carneiro  MM, Saleme  CS, Pinto  RZ, da Fonseca  AM, da Silva-Filho  AL.  Intensive supervised versus unsupervised pelvic floor muscle training for the treatment of stress urinary incontinence: a randomized comparative trial.  Int Urogynecol J. 2010;21(7):835-840. doi:10.1007/s00192-010-1125-1PubMedGoogle ScholarCrossref
    14.
    de Oliveira Camargo  F, Rodrigues  AM, Arruda  RM, Ferreira Sartori  MG, Girão  MJ, Castro  RA.  Pelvic floor muscle training in female stress urinary incontinence: comparison between group training and individual treatment using PERFECT assessment scheme.  Int Urogynecol J Pelvic Floor Dysfunct. 2009;20(12):1455-1462. doi:10.1007/s00192-009-0971-1PubMedGoogle ScholarCrossref
    15.
    Kim  H, Yoshida  H, Suzuki  T.  The effects of multidimensional exercise treatment on community-dwelling elderly Japanese women with stress, urge, and mixed urinary incontinence: a randomized controlled trial.  Int J Nurs Stud. 2011;48(10):1165-1172. doi:10.1016/j.ijnurstu.2011.02.016PubMedGoogle ScholarCrossref
    16.
    Janssen  CC, Lagro-Janssen  AL, Felling  AJ.  The effects of physiotherapy for female urinary incontinence: individual compared with group treatment.  BJU Int. 2001;87(3):201-206. doi:10.1046/j.1464-410x.2001.02040.xPubMedGoogle ScholarCrossref
    17.
    Tak  EC, van Hespen  A, van Dommelen  P, Hopman-Rock  M.  Does improved functional performance help to reduce urinary incontinence in institutionalized older women? a multicenter randomized clinical trial.  BMC Geriatr. 2012;12:51. doi:10.1186/1471-2318-12-51PubMedGoogle ScholarCrossref
    18.
    Diokno  AC, Sampselle  CM, Herzog  AR,  et al.  Prevention of urinary incontinence by behavioral modification program: a randomized, controlled trial among older women in the community.  J Urol. 2004;171(3):1165-1171. doi:10.1097/01.ju.0000111503.73803.c2PubMedGoogle ScholarCrossref
    19.
    Sampselle  CM, Newman  DK, Miller  JM,  et al.  A randomized controlled trial to compare 2 scalable interventions for lower urinary tract symptom prevention: main outcomes of the TULIP study.  J Urol. 2017;197(6):1480-1486. doi:10.1016/j.juro.2016.12.099PubMedGoogle ScholarCrossref
    20.
    Tannenbaum  C, Agnew  R, Benedetti  A, Thomas  D, van den Heuvel  E.  Effectiveness of continence promotion for older women via community organisations: a cluster randomised trial.  BMJ Open. 2013;3(12):e004135. doi:10.1136/bmjopen-2013-004135PubMedGoogle ScholarCrossref
    21.
    McFall  SL, Yerkes  AM, Cowan  LD.  Outcomes of a small group educational intervention for urinary incontinence: health-related quality of life.  J Aging Health. 2000;12(3):301-317. doi:10.1177/089826430001200302PubMedGoogle ScholarCrossref
    22.
    Diokno  AC, Ocampo  MS  Jr, Ibrahim  IA, Karl  CR, Lajiness  MJ, Hall  SA.  Group session teaching of behavioral modification program (BMP) for urinary incontinence: a randomized controlled trial among incontinent women.  Int Urol Nephrol. 2010;42(2):375-381. doi:10.1007/s11255-009-9626-xPubMedGoogle ScholarCrossref
    23.
    Messer  KL, Herzog  AR, Seng  JS,  et al.  Evaluation of a mass mailing recruitment strategy to obtain a community sample of women for a clinical trial of an incontinence prevention intervention.  Int Urol Nephrol. 2006;38(2):255-261. doi:10.1007/s11255-006-0018-1PubMedGoogle ScholarCrossref
    24.
    Avery  K, Donovan  J, Peters  TJ, Shaw  C, Gotoh  M, Abrams  P.  ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence.  Neurourol Urodyn. 2004;23(4):322-330. doi:10.1002/nau.20041PubMedGoogle ScholarCrossref
    25.
    Diokno  AC, Dimaculangan  RR, Lim  EU, Steinert  BW.  Office based criteria for predicting type II stress incontinence without further evaluation studies.  J Urol. 1999;161(4):1263-1267. doi:10.1016/S0022-5347(01)61652-5PubMedGoogle ScholarCrossref
    26.
    Patrick  DL, Martin  ML, Bushnell  DM, Yalcin  I, Wagner  TH, Buesching  DP.  Quality of life of women with urinary incontinence: further development of the Incontinence Quality of Life Instrument (I-QOL)  [published correction appears in Urology. 1999;53(5):1072].  Urology. 1999;53(1):71-76. doi:10.1016/S0090-4295(98)00454-3PubMedGoogle ScholarCrossref
    27.
    Brink  CA, Wells  TJ, Sampselle  CM, Taillie  ER, Mayer  R.  A digital test for pelvic muscle strength in women with urinary incontinence.  Nurs Res. 1994;43(6):352-356. doi:10.1097/00006199-199411000-00006PubMedGoogle ScholarCrossref
    28.
    Borson  S, Scanlan  JM, Watanabe  J, Tu  SP, Lessig  M.  Simplifying detection of cognitive impairment: comparison of the Mini-Cog and Mini-Mental State Examination in a multiethnic sample.  J Am Geriatr Soc. 2005;53(5):871-874. doi:10.1111/j.1532-5415.2005.53269.xPubMedGoogle ScholarCrossref
    29.
    Shumway-Cook  A, Brauer  S, Woollacott  M.  Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test.  Phys Ther. 2000;80(9):896-903.PubMedGoogle Scholar
    30.
    Miller  JM, Ashton-Miller  JA, Delancey  JO.  Quantification of cough-related urine loss using the paper towel test.  Obstet Gynecol. 1998;91(5, pt 1):705-709.PubMedGoogle Scholar
    31.
    Locher  JL, Goode  PS, Roth  DL, Worrell  RL, Burgio  KL.  Reliability assessment of the bladder diary for urinary incontinence in older women.  J Gerontol A Biol Sci Med Sci. 2001;56(1):M32-M35. doi:10.1093/gerona/56.1.M32PubMedGoogle ScholarCrossref
    32.
    Lose  G, Jørgensen  L, Thunedborg  P.  24-Hour home pad weighing test versus 1-hour ward test in the assessment of mild stress incontinence.  Acta Obstet Gynecol Scand. 1989;68(3):211-215. doi:10.3109/00016348909020991PubMedGoogle ScholarCrossref
    33.
    Burgio  KL, Locher  JL, Goode  PS,  et al.  Behavioral vs drug treatment for urge urinary incontinence in older women: a randomized controlled trial.  JAMA. 1998;280(23):1995-2000. doi:10.1001/jama.280.23.1995PubMedGoogle ScholarCrossref
    34.
    Yalcin  I, Bump  RC.  Validation of two global impression questionnaires for incontinence.  Am J Obstet Gynecol. 2003;189(1):98-101. doi:10.1067/mob.2003.379PubMedGoogle ScholarCrossref
    35.
    Bureau of Labor Statistics, US Department of Labor. May 2016 national occupational employment and wages estimates, United States. https://www.bls.gov/oes/2016/may/oes_nat.htm. Last modified March 31, 2017. Accessed January 2017.
    36.
    Subak  L, Van Den Eeden  S, Thom  D, Creasman  JM, Brown  JS; Reproductive Risks for Incontinence Study at Kaiser Research Group.  Urinary incontinence in women: Direct costs of routine care.  Am J Obstet Gynecol. 2007;197(6):596.e1-596.e9. doi:10.1016/j.ajog.2007.04.029PubMedGoogle ScholarCrossref
    37.
    Bureau of Labor Statistics, US Department of Labor. Table 3: median usual weekly earnings of full-time wage and salary workers by age, race, Hispanic or Latino ethnicity, and sex, not seasonally adjusted. https://www.bls.gov/webapps/legacy/cpswktab3.htm. Last modified September 16, 2015. Accessed January 2017.
    38.
    Nyström  E, Sjöström  M, Stenlund  H, Samuelsson  E.  ICIQ symptom and quality of life instruments measure clinically relevant improvements in women with stress urinary incontinence.  Neurourol Urodyn. 2015;34(8):747-751. doi:10.1002/nau.22657PubMedGoogle ScholarCrossref
    39.
    Yalcin  I, Peng  G, Viktrup  L, Bump  RC.  Reductions in stress urinary incontinence episodes: what is clinically important for women?  Neurourol Urodyn. 2010;29(3):344-347.PubMedGoogle Scholar
    40.
    Diokno  AC, Ogunyemi  T, Siadat  MR, Arslanturk  S, Killinger  KA.  Continence Index: a new screening questionnaire to predict the probability of future incontinence in older women in the community.  Int Urol Nephrol. 2015;47(7):1091-1097. doi:10.1007/s11255-015-1006-0PubMedGoogle ScholarCrossref
    41.
    Wagner  TH, Moore  KH, Subak  LL, deWatcher  S, Dudding  T. Economics of urinary and fecal incontinence and prolapse. In: Abrams P, Cardozo L, Wagg A, Wein A, eds.  Incontinence: 6th International Consultation on Incontinence. Bristol, UK: ICI-ICS (International Continence Society); 2017:2479-2511.
    ×