Status:
TERMINATED
PTNS vs Botox of Refractory OAB
Lead Sponsor:
Medstar Health Research Institute
Collaborating Sponsors:
University of Michigan
Methodist Urology Associates, Houston, Texas
Conditions:
Overactive Bladder (OAB)
Eligibility:
FEMALE
18+ years
Brief Summary
This is a prospective cohort study of women with overactive bladder OAB (dry or wet) who have failed 2 prior treatments, including behavioral modification, pelvic floor physical therapy, and/or OAB me...
Detailed Description
Prior to initiation of BTX or PTNS, patients will undergo a standardized evaluation including urodynamics study (UDS) if not previously done in the past year and pelvic organ prolapse quantification (...
Eligibility Criteria
Inclusion
- Women with refractory OAB (dry or wet)
- OAB will be defined by a positive response and bother of "somewhat, quite a bit, a great deal, or a very great deal" to question #3 or #8 on the OAB-q (see appendix B) regarding urinary urgency and urgency incontinence.
- Refractory will be defined as failure of 2 prior treatments, including behavioral modification, pelvic floor physical therapy, and OAB medication (anticholinergics or mirabegron). Trial of 2 medications that did not improve symptoms after 2 weeks or could not be tolerated due to side effects will constitute 2 treatment failures.
- Women with mixed urinary incontinence that is urge predominant will also be included.
- Age ≥ 18 years
- English speaking
- Available for 1 year follow-up
- Able to complete study questionnaires
Exclusion
- Neurologic disease known to cause OAB including, but not limited to, Multiple sclerosis, Parkinson's disease, and Spinal Cord Injury.
- Pregnancy by self-report or pregnancy test
- Contraindication to PTNS and/or BTX
- PTNS: Pacemaker
- BTX: myasthenia gravis, allergy to BTX, urinary retention (post void residual \>200cc)
- Planned surgery for pelvic floor disorder during the study period
- Prior treatment with BTX, PTNS, or sacral nerve stimulation (SNS) for refractory OAB/urinary urge incontinence (UUI)
Key Trial Info
Start Date :
March 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04451382
Start Date
March 1 2015
End Date
December 1 2018
Last Update
June 30 2020
Active Locations (2)
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1
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
2
Columbia University
New York, New York, United States, 10032