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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The primary aim of this study is to test if the addition of behavioral treatment to drug therapy for the treatment of urge incontinence will increase the number of patients who can discontinue drug therapy and sustain a significant reduction of incontinence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination therapy | Experimental | Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication (tolterodine) and behavioral training. |
|
| Drug therapy alone | Active Comparator | Women assigned to this arm received 10 weeks of anti-cholinergic medication (tolterodine), only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolterodine | Drug | 4mg/d for 10 weeks. Could be reduced to 2mg/d for managing side effects. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Women Who Meet Definition of Success | Proportion of women who meet definition of success: not taking drug or receiving other urge UI therapy (i.e., neuromodulation, botox injections, myomectomy, electrical stimulation, or any intravesical therapy) and not taking a tricyclic antidepressant or duloxetine at 8 months; and a >70% reduction in number of incontinence episodes as compared to baseline. | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Incontinence Episodes | Change from baseline to 10 weeks in number of incontinence episodes per week as reported on bladder diary. | Baseline and 10 weeks |
| Change in Voids Per Day | Change from baseline to 10 weeks in frequency of voids per day as reported on bladder diary |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| William D Steers, M.D. | University of Virginia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35233 | United States | ||
| University of California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16919506 | Background | Urinary Incontinence Treatment Network (UITN). Design of the Behavior Enhances Drug Reduction of Incontinence (BE-DRI) study. Contemp Clin Trials. 2007 Jan;28(1):48-58. doi: 10.1016/j.cct.2006.06.002. Epub 2006 Jun 18. | |
| 20671098 | Background | Borello-France D, Burgio KL, Goode PS, Markland AD, Kenton K, Balasubramanyam A, Stoddard AM; Urinary Incontinence Treatment Network. Adherence to behavioral interventions for urge incontinence when combined with drug therapy: adherence rates, barriers, and predictors. Phys Ther. 2010 Oct;90(10):1493-505. doi: 10.2522/ptj.20080387. Epub 2010 Jul 29. |
| Label | URL |
|---|---|
| www.uitn.net | View source |
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Of the 134 found to be ineligible after consent, for 77 their urinary incontinence (UI) was not urge predominant, 19 had fewer than 7 episodes of incontinence per week and the other 38 were excluded for a variety of reasons.
Between July, 2004 and January, 2006 4,043 women were screened for eligibility and 561 provided written consent. After further screening, 134 were found to be ineligible, 119 withdrew consent and 1 was excluded erroneously. The remaining 307 were randomized to one of the treatment arms.
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| ID | Title | Description |
|---|---|---|
| FG000 | Combination Therapy | Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training. |
| FG001 | Drug Therapy Alone | Women assigned to this arm received 10 weeks of anti-cholinergic medication, only. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline to 10 Weeks |
|
| ||||||||||||||||||
| Baseline to 8 Months |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Combination Therapy | Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training. |
| BG001 | Drug Therapy Alone | Women assigned to this arm received 10 weeks of anti-cholinergic medication, only. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Women Who Meet Definition of Success | Proportion of women who meet definition of success: not taking drug or receiving other urge UI therapy (i.e., neuromodulation, botox injections, myomectomy, electrical stimulation, or any intravesical therapy) and not taking a tricyclic antidepressant or duloxetine at 8 months; and a >70% reduction in number of incontinence episodes as compared to baseline. | All women who completed the 8 months assessment or were known to return to drug use prior to that time. | Posted | Number | participants | 8 months |
|
Participants were monitored for adverse events throughout the study period (8 months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Combination Therapy | Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Glaucoma | Eye disorders | Systematic Assessment |
Ony 68% of participants completed assigned treatment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Stoddard, ScD | New England Research Institutes | 617-972-3331 | astoddard@neriscience.com |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000068737 | Tolterodine Tartrate |
| ID | Term |
|---|---|
| D010665 | Phenylpropanolamine |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Behavioral training | Behavioral | Training in pelvic floor muscle control and exercises; behavioral strategies to diminish urgency, suppress bladder contractions and prevent incontinence; delayed voiding; and individualized fluid management. |
|
| baseline and 10 weeks |
| Symptom Distress | Urogenital distress inventory (UDI). Higher score indicates greater distress. Possible range 0 to 300. | baseline, 10 weeks and 8 months |
| Symptom Bother | Disease specific overactive bladder scale (OAB-q). HIgher score indicates greater bother. Possible range 0 to 100. | baseline, 10 weeks and 8 months |
| Satisfaction | Number of women who responded "completely satisfied" to question, "How satisfied are you with your progress?" | 10 weeks |
| Satisfaction | Number of women who responded "completely satisfied" to question "How satisfied are you with your progress?" | 8 months |
| Symptom Improvement | Number of women who responded "much better" or "better" to question: "Overall, do you feel that you are much better, better, about the same, worse or much worse?" | 10 weeks |
| Symptom Improvement | Number of women who responded "much better" or "better" to question: "Overall, do you feel that you are much better, better, about the same, worse or much worse?" | 8 months |
| San Diego |
| California |
| 92103 |
| United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Oakwood Hospital and Medical Center | Royal Oak | Michigan | 48123 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
| University of Texas Health Sciences Center | San Antonio | Texas | 78229 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| 21181960 | Background | Brubaker L, Lukacz ES, Burgio K, Zimmern P, Norton P, Leng W, Johnson H, Kraus S, Stoddard A. Mixed incontinence: comparing definitions in non-surgical patients. Neurourol Urodyn. 2011 Jan;30(1):47-51. doi: 10.1002/nau.20922. |
| 20143047 | Background | Burgio KL, Kraus SR, Borello-France D, Chai TC, Kenton K, Goode PS, Xu Y, Kusek JW; Urinary Incontinence Treatment Network. The effects of drug and behavior therapy on urgency and voiding frequency. Int Urogynecol J. 2010 Jun;21(6):711-9. doi: 10.1007/s00192-010-1100-x. Epub 2010 Feb 9. |
| 18678843 | Background | 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; Urinary Incontinence Treatment Network. Behavioral therapy to enable women with urge incontinence to discontinue drug treatment: a randomized trial. Ann Intern Med. 2008 Aug 5;149(3):161-9. doi: 10.7326/0003-4819-149-3-200808050-00005. |
| 18704249 | Background | Fitzgerald MP, Lemack G, Wheeler T, Litman HJ; Urinary Incontinence Treatment Network. Nocturia, nocturnal incontinence prevalence, and response to anticholinergic and behavioral therapy. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Nov;19(11):1545-50. doi: 10.1007/s00192-008-0687-7. Epub 2008 Aug 14. |
| 20945064 | Background | Goode PS, Burgio KL, Kraus SR, Kenton K, Litman HJ, Richter HE; Urinary Incontinence Treatment Network. Correlates and predictors of patient satisfaction with drug therapy and combined drug therapy and behavioral training for urgency urinary incontinence in women. Int Urogynecol J. 2011 Mar;22(3):327-34. doi: 10.1007/s00192-010-1287-x. Epub 2010 Oct 13. |
| 19200939 | Background | Markland AD, Richter HE, Kenton KS, Wai C, Nager CW, Kraus SR, Xu Y, Tennstedt SL; Urinary Incontinence Treatment Network. Associated factors and the impact of fecal incontinence in women with urge urinary incontinence: from the Urinary Incontinence Treatment Network's Behavior Enhances Drug Reduction of Incontinence study. Am J Obstet Gynecol. 2009 Apr;200(4):424.e1-8. doi: 10.1016/j.ajog.2008.11.023. Epub 2009 Feb 6. |
| 19183825 | Background | Richter HE, Burgio KL, Chai TC, Kraus SR, Xu Y, Nyberg L, Brubaker L. Predictors of outcomes in the treatment of urge urinary incontinence in women. Int Urogynecol J Pelvic Floor Dysfunct. 2009 May;20(5):489-97. doi: 10.1007/s00192-009-0805-1. Epub 2009 Jan 30. |
| 19912207 | Background | Zimmern P, Litman HJ, Mueller E, Norton P, Goode P; Urinary Incontinence Treatment Network. Effect of fluid management on fluid intake and urge incontinence in a trial for overactive bladder in women. BJU Int. 2010 Jun;105(12):1680-5. doi: 10.1111/j.1464-410X.2009.09055.x. Epub 2009 Nov 13. |
| 22453106 | Background | Fitzgerald MP, Dubeau CE, Kraus SR, Johnson HW Jr, Rahn DD, Mallett V, Stoddard AM, Zyczynski HM; Urinary Incontinence Treatment Network. Patient expectations did not predict outcome of drug and behavioral treatment of urgency urinary incontinence. Female Pelvic Med Reconstr Surg. 2011 Sep;17(5):231-7. doi: 10.1097/SPV.0b013e31822dd10b. |
| 21563210 | Background | Dyer KY, Xu Y, Brubaker L, Nygaard I, Markland A, Rahn D, Chai TC, Stoddard A, Lukacz E; Urinary Incontinence Treatment Network (UITN). Minimum important difference for validated instruments in women with urge incontinence. Neurourol Urodyn. 2011 Sep;30(7):1319-24. doi: 10.1002/nau.21028. Epub 2011 May 11. |
| 37811598 | Derived | Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2. |
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Women assigned to this arm received 10 weeks of anti-cholinergic medication, only. |
|
|
|
| Secondary | Change in Incontinence Episodes | Change from baseline to 10 weeks in number of incontinence episodes per week as reported on bladder diary. | All women with valid bladder diary at baseline and 10 weeks in each treatment group. | Posted | Mean | Standard Error | incontinence episodes per week | Baseline and 10 weeks |
|
|
|
|
| Secondary | Change in Voids Per Day | Change from baseline to 10 weeks in frequency of voids per day as reported on bladder diary | All women with valid bladder diary at baseline and 10 weeks in each treatment group. | Posted | Mean | Standard Error | voids per day | baseline and 10 weeks |
|
|
|
|
| Secondary | Symptom Distress | Urogenital distress inventory (UDI). Higher score indicates greater distress. Possible range 0 to 300. | All women who completed UDI at each time in each treatment group | Posted | Mean | Standard Deviation | units on a scale | baseline, 10 weeks and 8 months |
|
|
|
|
| Secondary | Symptom Bother | Disease specific overactive bladder scale (OAB-q). HIgher score indicates greater bother. Possible range 0 to 100. | Participants who completed OAB-q assessment at each time in each treatment group. | Posted | Mean | Standard Deviation | units on a scale | baseline, 10 weeks and 8 months |
|
|
|
|
| Secondary | Satisfaction | Number of women who responded "completely satisfied" to question, "How satisfied are you with your progress?" | Number of women who completed satisfaction question at 10 weeks. | Posted | Number | participants | 10 weeks |
|
|
|
|
| Secondary | Satisfaction | Number of women who responded "completely satisfied" to question "How satisfied are you with your progress?" | Number of participants who completed the 8 months satisfaction questions | Posted | Number | participants | 8 months |
|
|
|
|
| Secondary | Symptom Improvement | Number of women who responded "much better" or "better" to question: "Overall, do you feel that you are much better, better, about the same, worse or much worse?" | Participants who completed the satisfaction item at 10 weeks. | Posted | Number | participants | 10 weeks |
|
|
|
|
| Secondary | Symptom Improvement | Number of women who responded "much better" or "better" to question: "Overall, do you feel that you are much better, better, about the same, worse or much worse?" | Participants who completed the perceived improvement item at 8 months. | Posted | Number | participants | 8 months |
|
|
|
|
| 2 |
| 154 |
| 2 |
| 154 |
| EG001 | Drug Therapy Alone | Women assigned to this arm received 10 weeks of anti-cholinergic medication, only. | 2 | 153 | 1 | 153 |
| Small bowl obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Renal cell carcinoma | Renal and urinary disorders | Systematic Assessment |
|
| Peripheral edema | Renal and urinary disorders | Systematic Assessment |
|
| Syncopal episode | Cardiac disorders | Systematic Assessment |
|
| Night sweats | Renal and urinary disorders | Systematic Assessment |
|
| Stomach cramping | Gastrointestinal disorders | Systematic Assessment |
|
| Weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003408 | Cresols |
| D010636 | Phenols |