Mixed Incontinence: Medical Or Surgical Approach?

Study Overview
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Brief Summary
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The purpose of this study is to compare treatment outcomes for patients with mixed urinary incontinence (MUI) for whom therapy is initiated with surgery to those for whom therapy is initiated with non-surgical treatment. Women who are bothered by symptoms of both stress and urge incontinence will be randomly assigned to initiate treatment with a surgical (surgery for stress incontinence) vs. a non-surgical (drug and behavioral therapy) approach. Follow-up will be a minimum of 12 Months.

Detailed Description
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The purpose of this study is to compare treatment outcomes for patients with mixed urinary incontinence (MUI) for whom therapy is initiated with surgery to those for whom therapy is initiated with non-surgical treatment. Women who are bothered by symptoms of both stress and urge incontinence will be randomly assigned to initiate treatment with a surgical (surgery for stress incontinence) vs. a non-surgical (drug and behavioral therapy) approach. Follow-up will be a minimum of 12 Months.

Official Title
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Mixed Incontinence: Medical Or Surgical Approach?

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Drug: Non-Surgical Intervention
* Procedure: Surgical


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Mixed UI as evidenced by stress and urge symptoms reported on MESA (either percent of urge-type symptoms ≥ the percent of stress-type symptoms or urge symptom score ≥7 if stress predominant) followed by report of moderately or greatly/quite a bit bothered to questions 2 and 3 of the 6-item Urinary Distress Index (UDI-6) or questions 16 and 17 of the 20-item Pelvic Fl;oor Distress Index (PFDI-20), respectively (See Appendix C) Moderate or severe UI as evidenced by the corresponding response on the Patient Global Impression of Severity (PGI-S) Incontinence symptoms present for at least (3) months* Bladder capacity > 200cc (by any method) Urodynamic Stress Incontinence Eligible for both treatment interventions Available to start intervention within 6 weeks Negative urine dipstick (negative result = trace or less for leukocytes & nitrites) Available for 12 months of follow-up and able to complete study assessments as per clinician judgment Signed consent form Exclusion Criteria: Age <21 years* Currently undergoing or recommended to undergo treatment of pelvic organ prolapse Other indicated/planned concomitant surgery Pregnant or has not completed child bearing* <12 months post-partum*† Active malignancy of cervix, uterus, fallopian tube(s) or ovary > Stage I, or bladder of any Stage Current catheter use Unevaluated hematuria Participation in another trial that may influence the results of this study Patient can be rescreened after respective time interval has been met. †Partum is defined as a delivery or other termination that occurs after 20 weeks gestation.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgical Treatment<br>Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension. | Procedure: Surgical<br>* Initial surgical (stress incontinence surgery) treatment approach.<br>* Other names: Surgical Treatment;|
| Active Comparator: Non Surgical Treatment<br>The non-surgical treatment will include two components: Pharmacological therapy with any FDA approved overactive bladder (OAB) drug in approved doses; and Behavioral therapy. | Drug: Non-Surgical Intervention<br>* Both oral urge incontinence medication and behavioral treatment<br>* Other names: Non-Surgical Treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimal Outcome of Treatment at 6 Months | Composite measure defined as much better or very much better on Patient Global Impression of Improvement (PGI-I) and normal or mild on Patient Global Impression of Symptoms (PGI-S). PGI-I is a single item: Circle the one answer that best describes your urinary tract condition now, compared to how it was before your incontinence treatment with responses ranging from 1= Very much better to 7= Very much worse. The PGI-S is a single item:; Circle the one number that best describes how your urinary tract condition is now with responses ranging from 1 = Normal to 4 Severe. | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimal Outcome of Treatment at 3 Months | Composite measure defined as much better or very much better om PGI-I and normal or mild on PGI-S. PGI-I is a single item: Circle the one answer that best describes how your urinary tract condition is now, compared with how it was before your incontinence treatment with responses ranging from 1=Very much better to 7=Very much worse. PGI-S is a single items: Circle the one number that best describes how your urinary tract condition is now with responses ranging from 1=Normal to 4=Severe. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress urinary incontinence, Mixed, Urge