Overview

Sling vs Botox for Mixed Incontinence

Status:
Recruiting
Trial end date:
2022-11-01
Target enrollment:
0
Participant gender:
Female
Summary
The primary aim is to compare the effectiveness of intradetrusor injection of 100 unit injection of Botulinum toxin A to mid-urethral sling for change in MUI symptoms 6 months following treatment.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
NICHD Pelvic Floor Disorders Network
Collaborators:
Duke University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Kaiser Permanente
RTI International
University of Alabama at Birmingham
University of California, San Diego
University of Pennsylvania
University of Pittsburgh
University of Texas Southwestern Medical Center
Women and Infants Hospital of Rhode Island
Treatments:
abobotulinumtoxinA
Botulinum Toxins
Botulinum Toxins, Type A
Criteria
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