Sling vs Botox for Mixed Incontinence (MUSA)

This is an interventional treatment trial for Urinary Incontinence, Stress focused on measuring urinary incontinence, midurethral sling, Botulinum toxin A (Botox A ®) Read More

Inclusion Criteria:

1. Reporting at least "moderate bother" from UUI item on UDI

   * "Do you experience urine leakage associated with a feeling of urgency?"

2. Reporting at least "moderate bother" from SUI item on UDI

   * "Do you experience urine leakage related to physical activity, coughing, or sneezing?"

3. Diagnosis of SUI defined by a positive cough stress test (CST) or UDE within the past 18 months
4. Presence of UUI on bladder diary with > 4 Urgency IE/3-day diary
5. Urinary symptoms >3 months
6. Persistent symptoms despite at least one or more conservative treatments (e.g. supervised behavioral therapy, physical therapy) as determined adequate by the physician.

7. Inadequate response to oral overactive bladder medications (including anti-cholinergic and/or beta-mimetic medication) unless patient is

   1. intolerant of oral overactive bladder medications, or
   2. oral overactive bladder medications are contraindicated as determined by the treating provider.
8. Urodynamics within past 18 months
9. Demonstrates ability (or have caregiver demonstrate ability) to perform clean intermittent self-catheterization.

Exclusion Criteria:

1. Anterior or apical compartment prolapse at or beyond the hymen (>0 on POPQ), regardless if patient is symptomatic

   * 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

   * Women undergoing only rectocele repair or other repair unrelated to anterior or apical compartment 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 6 months, or within 12 months post-partum
7. Post-void residual >150 cc on 2 occasions within the past 6 months, 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 urinary incontinence
11. Spinal cord injury or advanced/severe neurologic conditions including Multiple Sclerosis, Parkinsons, Myasthenia Gravis, Charcot-Marie-Tooth
12. Women on overactive bladder medication/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 6 month follow-up
16. Diagnosis of and/or history of bladder pain or chronic pelvic pain
17. Women who had intravesical Botox injection within the past 12 months
18. Women who have undergone anterior or apical pelvic organ prolapse repair within the past 6 months