PTNS vs Botox of Refractory OAB
Stopped early
Conditions studied: Overactive Bladder (OAB)
In brief
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 medication (anticholinergics or mirabegron), and have chosen either OnabotulinumtoxinA (BTX) injection or percutaneous tibial nerve stimulation (PTNS) as their next treatment. OAB-dry refers to patients with OAB who do not have urge urinary incontinence; OAB-wet refers to patients with OAB and urge urinary incontinence. Eligible patients will be approached for study participation after they have decided to proceed with BTX or PTNS.
Key facts
- Study ID
- NCT04451382
- Run by
- Medstar Health Research Institute
- People needed
- 150
- Starts
- 2015-03-01
- Expected to finish
- 2018-12-01
- Last updated by the study team
- 2020-06-30
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
- Columbia University — New York, New York, United States
Full record on ClinicalTrials.gov
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