Mixed Incontinence: Medical Or Surgical Approach? (MIMOSA)

Carelon Research

Status and phase: Terminated; Phase 4

Conditions: Urinary Incontinence

Treatments: Drug: Non-Surgical Intervention; Procedure: Surgical

Study type: Interventional

Funder types: Other

Identifiers

NCT00803270

MIMOSA (terminated)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Surgical Treatment

Active Comparator group

Description:

Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.

Treatment:

Procedure: Surgical

Non Surgical Treatment

Active Comparator group

Description:

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.

Treatment:

Drug: Non-Surgical Intervention