Status:
COMPLETED
Vaginal Electrical Stimulation Versus Neuromodulation
Lead Sponsor:
University of Oklahoma
Conditions:
Refractory Overactive Bladder
Eligibility:
FEMALE
21-99 years
Brief Summary
This prospective study compares quality of life measures of patients with refractory overactive bladder, between two modes of neuromodulation: vaginal electrical stimulation (Group A) and sacral nerve...
Detailed Description
All participants will have a standardized intake history which will include age, weight, history of prior treatment for incontinence, medication list, obstetric and gynecologic history, medical histor...
Eligibility Criteria
Inclusion
- Diagnosis of refractory OAB (+/- UUI)\*
- Female Gender
- Eligible for both treatment interventions
- Available for 8 weeks of follow-up
- Able to complete study assessments
- Must discontinue anticholinergics within 2 weeks of intervention
Exclusion
- Age \< 21
- Pregnancy
- Stage 3 or 4 pelvic organ prolapse
- Current use of anticholinergics
- Urinary tract infection
- Undergoing concurrent treatment for pelvic organ prolapse
- Unstable or serious cardiac arrhythmia
- Implanted pacemaker
- Postvoid residual \> 100ml
- Unstable seizure disorder
- Dementia or inability to follow instructions
Key Trial Info
Start Date :
March 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01525485
Start Date
March 1 2011
End Date
April 1 2016
Last Update
June 9 2016
Active Locations (1)
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1
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104