Mixed Incontinence: Medical Or Surgical Approach?

Phase 4

Terminated

• Conditions: Urinary Incontinence
• Interventions: Procedure: Surgical; Drug: Non-Surgical Intervention

• Registration Number: NCT00803270
• Lead Sponsor: Carelon Research

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-12-04
• Study First Submitted QC: 2008-12-04
• Study First Posted: 2008-12-05
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2012-03-26
• Results First Submitted QC: 2012-04-12
• Results First Posted: 2012-05-11
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-08
• Last Update Posted: 2013-05-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 27

Inclusion Criteria

1. Female
2. 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)
3. Moderate or severe UI as evidenced by the corresponding response on the Patient Global Impression of Severity (PGI-S)
4. Incontinence symptoms present for at least (3) months*
5. Bladder capacity > 200cc (by any method)
6. Urodynamic Stress Incontinence
7. Eligible for both treatment interventions
8. Available to start intervention within 6 weeks
9. Negative urine dipstick (negative result = trace or less for leukocytes & nitrites)
10. Available for 12 months of follow-up and able to complete study assessments as per clinician judgment
11. Signed consent form

Exclusion Criteria

1. Age <21 years*

2. Currently undergoing or recommended to undergo treatment of pelvic organ prolapse

3. Other indicated/planned concomitant surgery

4. Pregnant or has not completed child bearing*

5. <12 months post-partum*†

6. Active malignancy of cervix, uterus, fallopian tube(s) or ovary > Stage I, or bladder of any Stage

7. Current catheter use

8. Unevaluated hematuria

9. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical Treatment	Surgical	Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.
Non Surgical Treatment	Non-Surgical Intervention	The non-surgical treatment will include two components: 1. Pharmacological therapy with any FDA approved overactive bladder (OAB) drug in approved doses; and 2. Behavioral therapy.

Primary Outcome Measures

Name	Time	Method
Optimal Outcome of Treatment at 6 Months	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".

Secondary Outcome Measures

Name	Time	Method
Optimal Outcome of Treatment at 3 Months	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."

Trial Locations

Locations (10)

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States

Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Oakwood Hospital/Cancer Center; 🇺🇸 Dearborn, Michigan, United States

University of Texas Southwestern; 🇺🇸 Dallas, Texas, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

University of California; 🇺🇸 San Diego, California, United States

University of Texas Health Sciences Center; 🇺🇸 San Antonio, Texas, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States