Behavioral therapy to enable women with urge incontinence to discontinue drug treatment

A randomized trial

Kathryn L. Burgio, Stephen R. Kraus, Shawn Menefee, Diane Borello-France, Marlene Corton, Harry W. Johnson, Veronica Mallett, Peggy Norton, Mary P. FitzGerald, Kimberly J. Dandreo, Holly E. Richter, Thomas Rozanski, Michael Albo, Halina M. Zyczynski, Gary E. Lemack, Toby C. Chai, Salil Khandwala, Jan Baker, Linda Brubaker, Anne M. Stoddard & 9 others Patricia S. Goode, Betsy Nielsen-Omeis, Charles W. Nager, Kimberly Kenton, Sharon L. Tennstedt, John W. Kusek, T. Debuene Chang, Leroy M. Nyberg, William Steers

Research output: Contribution to journalArticle

84 Citations (Scopus)

Abstract

Background: Women with urge urinary incontinence are commonly treated with antimuscarinic medications, but many discontinue therapy. Objective: To determine whether combining antimuscarinic drug therapy with supervised behavioral training, compared with drug therapy alone, improves the ability of women with urge incontinence to achieve clinically important reductions in incontinence episodes and to sustain these improvements after discontinuing drug therapy. Design: 2-stage, multicenter, randomized clinical trial conducted from July 2004 to January 2006. Setting: 9 university-affiliated outpatient clinics. Patients: 307 women with urge-predominant incontinence. Intervention: 10 weeks of open-label, extended-release tolterodine alone (n = 153) or combined with behavioral training (n = 154), followed by discontinuation of therapy and follow-up at 8 months. Measurements: The primary outcome, measured at 8 months, was no receipt of drugs or other therapy for urge incontinence and a 70% or greater reduction in frequency of incontinence episodes. Secondary outcomes were reduction in incontinence, self-reported satisfaction and improvement, and scores on validated questionnaires measuring symptom distress and bother and health-related quality of life. Study staff who performed outcome evaluations, but not participants and interventionists, were blinded to group assignment. Results: 237 participants completed the trial. According to life-table estimates, the rate of successful discontinuation of therapy at 8 months was the same in the combination therapy and drug therapy alone groups (41% in both groups; difference, 0 percentage points [95% CI, -12 to 12 percentage points]). A higher proportion of participants who received combination therapy than drug therapy alone achieved a 70% or greater reduction in incontinence at 10 weeks (69% vs. 58%; difference, 11 percentage points [CI, -0.3 to 22.1 percentage points]). Combination therapy yielded better outcomes over time on the Urogenital Distress Inventory and the Overactive Bladder Questionnaire (both P <0.001) at both time points for patient satisfaction and perceived improvement but not health-related quality of life. Adverse events were uncommon (12 events in 6 participants [3 in each group]). Limitations: Behavioral therapy components (daily bladder diary and recommendations for fluid management) in the group receiving drug therapy alone may have attenuated between-group differences. Assigned treatment was completed by 68% of participants, whereas 8-month outcome status was assessed on 77%. Conclusion: The addition of behavioral training to drug therapy may reduce incontinence frequency during active treatment but does not improve the ability to discontinue drug therapy and maintain improvement in urinary incontinence. Combination therapy has a beneficial effect on patient satisfaction, perceived improvement, and reduction of other bladder symptoms.

Original languageEnglish (US)
Pages (from-to)161-169
Number of pages9
JournalAnnals of Internal Medicine
Volume149
Issue number3
StatePublished - Aug 5 2008

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Urge Urinary Incontinence
Pharmaceutical Preparations
Drug Therapy
Therapeutics
Muscarinic Antagonists
Patient Satisfaction
Urinary Bladder
Quality of Life
Overactive Urinary Bladder
Aptitude
Life Tables
Urinary Incontinence
Ambulatory Care Facilities
Randomized Controlled Trials

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Burgio, K. L., Kraus, S. R., Menefee, S., Borello-France, D., Corton, M., Johnson, H. W., ... Steers, W. (2008). Behavioral therapy to enable women with urge incontinence to discontinue drug treatment: A randomized trial. Annals of Internal Medicine, 149(3), 161-169.

Behavioral therapy to enable women with urge incontinence to discontinue drug treatment : A randomized trial. / Burgio, Kathryn L.; Kraus, Stephen R.; Menefee, Shawn; Borello-France, Diane; Corton, Marlene; Johnson, Harry W.; Mallett, Veronica; Norton, Peggy; FitzGerald, Mary P.; Dandreo, Kimberly J.; Richter, Holly E.; Rozanski, Thomas; Albo, Michael; Zyczynski, Halina M.; Lemack, Gary E.; Chai, Toby C.; Khandwala, Salil; Baker, Jan; Brubaker, Linda; Stoddard, Anne M.; Goode, Patricia S.; Nielsen-Omeis, Betsy; Nager, Charles W.; Kenton, Kimberly; Tennstedt, Sharon L.; Kusek, John W.; Chang, T. Debuene; Nyberg, Leroy M.; Steers, William.

In: Annals of Internal Medicine, Vol. 149, No. 3, 05.08.2008, p. 161-169.

Research output: Contribution to journalArticle

Burgio, KL, Kraus, SR, Menefee, S, Borello-France, D, Corton, M, Johnson, HW, Mallett, V, Norton, P, FitzGerald, MP, Dandreo, KJ, Richter, HE, Rozanski, T, Albo, M, Zyczynski, HM, Lemack, GE, Chai, TC, Khandwala, S, Baker, J, Brubaker, L, Stoddard, AM, Goode, PS, Nielsen-Omeis, B, Nager, CW, Kenton, K, Tennstedt, SL, Kusek, JW, Chang, TD, Nyberg, LM & Steers, W 2008, 'Behavioral therapy to enable women with urge incontinence to discontinue drug treatment: A randomized trial', Annals of Internal Medicine, vol. 149, no. 3, pp. 161-169.
Burgio KL, Kraus SR, Menefee S, Borello-France D, Corton M, Johnson HW et al. Behavioral therapy to enable women with urge incontinence to discontinue drug treatment: A randomized trial. Annals of Internal Medicine. 2008 Aug 5;149(3):161-169.
Burgio, Kathryn L. ; Kraus, Stephen R. ; Menefee, Shawn ; Borello-France, Diane ; Corton, Marlene ; Johnson, Harry W. ; Mallett, Veronica ; Norton, Peggy ; FitzGerald, Mary P. ; Dandreo, Kimberly J. ; Richter, Holly E. ; Rozanski, Thomas ; Albo, Michael ; Zyczynski, Halina M. ; Lemack, Gary E. ; Chai, Toby C. ; Khandwala, Salil ; Baker, Jan ; Brubaker, Linda ; Stoddard, Anne M. ; Goode, Patricia S. ; Nielsen-Omeis, Betsy ; Nager, Charles W. ; Kenton, Kimberly ; Tennstedt, Sharon L. ; Kusek, John W. ; Chang, T. Debuene ; Nyberg, Leroy M. ; Steers, William. / Behavioral therapy to enable women with urge incontinence to discontinue drug treatment : A randomized trial. In: Annals of Internal Medicine. 2008 ; Vol. 149, No. 3. pp. 161-169.
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title = "Behavioral therapy to enable women with urge incontinence to discontinue drug treatment: A randomized trial",
abstract = "Background: Women with urge urinary incontinence are commonly treated with antimuscarinic medications, but many discontinue therapy. Objective: To determine whether combining antimuscarinic drug therapy with supervised behavioral training, compared with drug therapy alone, improves the ability of women with urge incontinence to achieve clinically important reductions in incontinence episodes and to sustain these improvements after discontinuing drug therapy. Design: 2-stage, multicenter, randomized clinical trial conducted from July 2004 to January 2006. Setting: 9 university-affiliated outpatient clinics. Patients: 307 women with urge-predominant incontinence. Intervention: 10 weeks of open-label, extended-release tolterodine alone (n = 153) or combined with behavioral training (n = 154), followed by discontinuation of therapy and follow-up at 8 months. Measurements: The primary outcome, measured at 8 months, was no receipt of drugs or other therapy for urge incontinence and a 70{\%} or greater reduction in frequency of incontinence episodes. Secondary outcomes were reduction in incontinence, self-reported satisfaction and improvement, and scores on validated questionnaires measuring symptom distress and bother and health-related quality of life. Study staff who performed outcome evaluations, but not participants and interventionists, were blinded to group assignment. Results: 237 participants completed the trial. According to life-table estimates, the rate of successful discontinuation of therapy at 8 months was the same in the combination therapy and drug therapy alone groups (41{\%} in both groups; difference, 0 percentage points [95{\%} CI, -12 to 12 percentage points]). A higher proportion of participants who received combination therapy than drug therapy alone achieved a 70{\%} or greater reduction in incontinence at 10 weeks (69{\%} vs. 58{\%}; difference, 11 percentage points [CI, -0.3 to 22.1 percentage points]). Combination therapy yielded better outcomes over time on the Urogenital Distress Inventory and the Overactive Bladder Questionnaire (both P <0.001) at both time points for patient satisfaction and perceived improvement but not health-related quality of life. Adverse events were uncommon (12 events in 6 participants [3 in each group]). Limitations: Behavioral therapy components (daily bladder diary and recommendations for fluid management) in the group receiving drug therapy alone may have attenuated between-group differences. Assigned treatment was completed by 68{\%} of participants, whereas 8-month outcome status was assessed on 77{\%}. Conclusion: The addition of behavioral training to drug therapy may reduce incontinence frequency during active treatment but does not improve the ability to discontinue drug therapy and maintain improvement in urinary incontinence. Combination therapy has a beneficial effect on patient satisfaction, perceived improvement, and reduction of other bladder symptoms.",
author = "Burgio, {Kathryn L.} and Kraus, {Stephen R.} and Shawn Menefee and Diane Borello-France and Marlene Corton and Johnson, {Harry W.} and Veronica Mallett and Peggy Norton and FitzGerald, {Mary P.} and Dandreo, {Kimberly J.} and Richter, {Holly E.} and Thomas Rozanski and Michael Albo and Zyczynski, {Halina M.} and Lemack, {Gary E.} and Chai, {Toby C.} and Salil Khandwala and Jan Baker and Linda Brubaker and Stoddard, {Anne M.} and Goode, {Patricia S.} and Betsy Nielsen-Omeis and Nager, {Charles W.} and Kimberly Kenton and Tennstedt, {Sharon L.} and Kusek, {John W.} and Chang, {T. Debuene} and Nyberg, {Leroy M.} and William Steers",
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TY - JOUR

T1 - Behavioral therapy to enable women with urge incontinence to discontinue drug treatment

T2 - A randomized trial

AU - Burgio, Kathryn L.

AU - Kraus, Stephen R.

AU - Menefee, Shawn

AU - Borello-France, Diane

AU - Corton, Marlene

AU - Johnson, Harry W.

AU - Mallett, Veronica

AU - Norton, Peggy

AU - FitzGerald, Mary P.

AU - Dandreo, Kimberly J.

AU - Richter, Holly E.

AU - Rozanski, Thomas

AU - Albo, Michael

AU - Zyczynski, Halina M.

AU - Lemack, Gary E.

AU - Chai, Toby C.

AU - Khandwala, Salil

AU - Baker, Jan

AU - Brubaker, Linda

AU - Stoddard, Anne M.

AU - Goode, Patricia S.

AU - Nielsen-Omeis, Betsy

AU - Nager, Charles W.

AU - Kenton, Kimberly

AU - Tennstedt, Sharon L.

AU - Kusek, John W.

AU - Chang, T. Debuene

AU - Nyberg, Leroy M.

AU - Steers, William

PY - 2008/8/5

Y1 - 2008/8/5

N2 - Background: Women with urge urinary incontinence are commonly treated with antimuscarinic medications, but many discontinue therapy. Objective: To determine whether combining antimuscarinic drug therapy with supervised behavioral training, compared with drug therapy alone, improves the ability of women with urge incontinence to achieve clinically important reductions in incontinence episodes and to sustain these improvements after discontinuing drug therapy. Design: 2-stage, multicenter, randomized clinical trial conducted from July 2004 to January 2006. Setting: 9 university-affiliated outpatient clinics. Patients: 307 women with urge-predominant incontinence. Intervention: 10 weeks of open-label, extended-release tolterodine alone (n = 153) or combined with behavioral training (n = 154), followed by discontinuation of therapy and follow-up at 8 months. Measurements: The primary outcome, measured at 8 months, was no receipt of drugs or other therapy for urge incontinence and a 70% or greater reduction in frequency of incontinence episodes. Secondary outcomes were reduction in incontinence, self-reported satisfaction and improvement, and scores on validated questionnaires measuring symptom distress and bother and health-related quality of life. Study staff who performed outcome evaluations, but not participants and interventionists, were blinded to group assignment. Results: 237 participants completed the trial. According to life-table estimates, the rate of successful discontinuation of therapy at 8 months was the same in the combination therapy and drug therapy alone groups (41% in both groups; difference, 0 percentage points [95% CI, -12 to 12 percentage points]). A higher proportion of participants who received combination therapy than drug therapy alone achieved a 70% or greater reduction in incontinence at 10 weeks (69% vs. 58%; difference, 11 percentage points [CI, -0.3 to 22.1 percentage points]). Combination therapy yielded better outcomes over time on the Urogenital Distress Inventory and the Overactive Bladder Questionnaire (both P <0.001) at both time points for patient satisfaction and perceived improvement but not health-related quality of life. Adverse events were uncommon (12 events in 6 participants [3 in each group]). Limitations: Behavioral therapy components (daily bladder diary and recommendations for fluid management) in the group receiving drug therapy alone may have attenuated between-group differences. Assigned treatment was completed by 68% of participants, whereas 8-month outcome status was assessed on 77%. Conclusion: The addition of behavioral training to drug therapy may reduce incontinence frequency during active treatment but does not improve the ability to discontinue drug therapy and maintain improvement in urinary incontinence. Combination therapy has a beneficial effect on patient satisfaction, perceived improvement, and reduction of other bladder symptoms.

AB - Background: Women with urge urinary incontinence are commonly treated with antimuscarinic medications, but many discontinue therapy. Objective: To determine whether combining antimuscarinic drug therapy with supervised behavioral training, compared with drug therapy alone, improves the ability of women with urge incontinence to achieve clinically important reductions in incontinence episodes and to sustain these improvements after discontinuing drug therapy. Design: 2-stage, multicenter, randomized clinical trial conducted from July 2004 to January 2006. Setting: 9 university-affiliated outpatient clinics. Patients: 307 women with urge-predominant incontinence. Intervention: 10 weeks of open-label, extended-release tolterodine alone (n = 153) or combined with behavioral training (n = 154), followed by discontinuation of therapy and follow-up at 8 months. Measurements: The primary outcome, measured at 8 months, was no receipt of drugs or other therapy for urge incontinence and a 70% or greater reduction in frequency of incontinence episodes. Secondary outcomes were reduction in incontinence, self-reported satisfaction and improvement, and scores on validated questionnaires measuring symptom distress and bother and health-related quality of life. Study staff who performed outcome evaluations, but not participants and interventionists, were blinded to group assignment. Results: 237 participants completed the trial. According to life-table estimates, the rate of successful discontinuation of therapy at 8 months was the same in the combination therapy and drug therapy alone groups (41% in both groups; difference, 0 percentage points [95% CI, -12 to 12 percentage points]). A higher proportion of participants who received combination therapy than drug therapy alone achieved a 70% or greater reduction in incontinence at 10 weeks (69% vs. 58%; difference, 11 percentage points [CI, -0.3 to 22.1 percentage points]). Combination therapy yielded better outcomes over time on the Urogenital Distress Inventory and the Overactive Bladder Questionnaire (both P <0.001) at both time points for patient satisfaction and perceived improvement but not health-related quality of life. Adverse events were uncommon (12 events in 6 participants [3 in each group]). Limitations: Behavioral therapy components (daily bladder diary and recommendations for fluid management) in the group receiving drug therapy alone may have attenuated between-group differences. Assigned treatment was completed by 68% of participants, whereas 8-month outcome status was assessed on 77%. Conclusion: The addition of behavioral training to drug therapy may reduce incontinence frequency during active treatment but does not improve the ability to discontinue drug therapy and maintain improvement in urinary incontinence. Combination therapy has a beneficial effect on patient satisfaction, perceived improvement, and reduction of other bladder symptoms.

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