Combined Treatment for Mixed Incontinence
Condition: Urinary Incontinence, Stress; Urinary Incontinence, Urge
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Urinary Incontinence, Urge
Intervention: Miduretheral Sling; Miduretheral Sling with behavioral/pelvic floor therapy
Intervention description: MUS can include the TVT™ (mechanical cut mesh only, Gynecare, ETHICON Women's Health & Urology, Somerville, NJ), TVT-O™ (mechanical cut mesh only, Gynecare), or Monarc™ (American Medical Systems, Minnetonka, MN).; MUS is combined with components of behavioral therapy (designed to change behaviors to encourage continence), and pelvic floor muscle therapy (designed to strengthen the pelvic floor muscles, enhance the physiological closure of the bladder neck, and improve coordination). This is done prior to MUS (1 visit) and after MUS for 5 visits at 2, 4, 6, 8 weeks and 6 months.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Enrollment: 480.0
Sex: Female
Minimum age: 21 Years
Healthy volunteers: No
Keywords: urinary incontinence; midurethral sling; pelvic floor therapy

Summary:

      The overarching goal of this randomized trial is to estimate the effect of combined
      midurethral sling (MUS) and peri-operative behavioral/pelvic floor therapy (BPTx) compared to
      MUS alone on successful treatment of MUI symptoms in 472 women. Secondary objectives include
      estimating the effect of combined treatment compared to MUS on improving overactive bladder
      (OAB) and stress urinary incontinence (SUI) outcomes separately, need for additional
      treatment, time to failure and identifying predictors of poor outcomes in this MUI
      population.

      A supplemental study, The Human Microbiome Study of ESTEEM, will evaluate the urinary and
      vaginal microbiome as it relates to women with MUI, their treatment and unaffected controls.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Presence of both SUI and UUI on bladder diary; and > 2 IEs/3 days

               1. > 1 Stress IE/3 day diary

               2. > 1 Urge IE/3 day diary

          2. Reporting at least "moderate bother" from UUI item on the UDI "Do you usually
             experience urine leakage associated with a feeling of urgency, that is a strong
             sensation of needing to go to the bathroom?"

          3. Reporting at least "moderate bother" from SUI item on UDI "Do you usually experience
             urine leakage related to coughing, sneezing, or laughing"

          4. Diagnosis of SUI defined by a positive cough stress test (CST) or urodynamic
             evaluation within the past 18 months

          5. Desires surgical treatment for SUI symptoms

          6. Urinary symptoms >3 months

          7. Subjects understand that BPTx is a treatment option for MUI outside of ESTEEM study
             protocol

          8. Urodynamics within past 18 months

        Exclusion Criteria:

          1. Anterior or apical compartment prolapse at or beyond the hymen (>0 on POPQ),
             regardless if patient is symptomatic

             a)Women with anterior or apical prolapse above the hymen (<0) who do not report
             vaginal bulge symptoms will be eligible

          2. Planned concomitant surgery for anterior vaginal wall or apical prolapse > 0

             a)Women undergoing only rectocele repair are eligible

          3. Women undergoing hysterectomy for any indication will be excluded

          4. Active pelvic organ malignancy

          5. Age <21 years

          6. Pregnant or plans for future pregnancy in next 12 months, or within 12 months
             post-partum

          7. Post-void residual >150 cc on 2 occasions, or current catheter use

          8. Participation in other trial that may influence results of this study

          9. Unevaluated hematuria

         10. Prior sling, synthetic mesh for prolapse, implanted nerve stimulator for incontinence

         11. Spinal cord injury or advanced/severe neurologic conditions including Multiple
             Sclerosis, Parkinsons

         12. Women on anti-muscarinic therapy will be eligible after 3 week wash-out period

         13. Non-ambulatory

         14. History of serious adverse reaction to synthetic mesh

         15. Not able to complete study assessments per clinician judgment, or not available for 12
             month follow-up

         16. Women who only report "other IE" on bladder diary, and do not report at minimum 1
             stress and 1 urge IE/3 days

         17. Diagnosis of and/or history of bladder pain or chronic pelvic pain

         18. Women who had intravesical Botox injection within the past 12 months