Refractory Overactive Bladder Clinical Trial
Official title:
Vaginal Electrical Stimulation Versus Sacral Neuromodulation for the Treatment of Refractory Overactive Bladder: A Pilot Study
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 stimulation (Group B).
The specific aims are:
1. To characterize patient symptom bother score, quality of life, and body image scores in
patients obtaining sacral nerve stimulation, as compared to vaginal electrical stimulation.
- Hypothesis 1: Both modes of neuromodulation will impact patients' scores in quality of
life, patient symptoms, and body image questionnaires.
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 history, and surgical history, as well as a complete review of systems. The
physical examination will include vital signs (including BMI), genitourinary exam, including
Pelvic Organ Prolapse Quantification (POPQ), and neurologic exam. All patients will undergo
spontaneous uroflowmetry, urine dipstick from catheterized specimen, multichannel
urodynamics, and 3-day voiding diary. Measurement of post-void residual will also be
obtained. Completion of the UDI-69, King's Health Questionnaire10, and the Modified Body
Image Perception Scale (MBIS) will also be part of the initial visit 11,12.
All participants taking anticholinergics will undergo a 2 week flush-out period prior to the
intake assessment. After the intake assessment, the provider will determine which treatment
option is appropriate to the participant, and they will then be assigned to one of the two
treatment arms: Group A will use vaginal electrical stimulation using the Empi Intravaginal
Stimulation Unit Minnova (Empi, St. Paul, MN, USA) and participants in Group B will receive
sacral neuromodulation using InterStim (Medtronic, Minneapolis, MN, USA).
;
Observational Model: Case Control, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02619721 -
Clinical Trial of Sacral Neuromodulation for Treatment of Refractory Overactive Bladder (OAB)
|
Phase 0 | |
| Not yet recruiting |
NCT02946723 -
A Study to Compare the Efficacy and Safety of Ultrasound Guided Lead Implantation for Sacral Neuromodulation (SNM) in Subjects With Overactive Bladder (OAB) With X-Ray Guided Technique
|
Phase 1 |