An observational study in Refractory Overactive Bladder, sponsored by University of Oklahoma. Completed at 1 site in United States. Open to female participants aged 21 Years to 99 Years. Per ClinicalTrials.gov, last updated 2016-06-09.
Sponsored by University of Oklahoma · Observational
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).
864 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's enrollment of 34 is below the median of 109 across 167 observational studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →University of Oklahoma is the lead sponsor of 432 studies on the registry; 100 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
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The projected sample size is 48 patients. We anticipate the recruitment of 16 patients for the InterStim arm of this study and 32 patients who will undergo vaginal electrical stimulation. Participants will be drawn from the University of Oklahoma Urogynecology clinics. Our catchment area includes OU Physicians clinic (private clinic) and Presbyterian Professional Building (resident clinic). Our referral area includes all of Oklahoma as well as the surrounding states. Participants will be recruited by physician referrals as well as by campus advertisements.
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Exclusion Criteria:
Participants will have a dedicated visit with a pelvic floor physical therapist during which instructions on usage and technique for the Minnova unit will be given. The electrical parameters selected will be: 10 Hertz frequency, 5-second on/10=second off cycle, and a pulse width of 0.4 milliseconds. The bipolar square will be delivered over a range that varies from 0 to 100 milliamps, depending on the maximum current intensity comfortably tolerated by the patient. The participant will perform each treatment session for 20 minutes twice daily for 8 weeks. Participants will be asked to keep a log recording the dates, times, and duration of each treatment session.
Participants assigned to the sacral neuromodulation group will undergo InterStim device placement by one of the three Urogynecologists at OUHSC using a staged implant technique according to manufacturer's specifications.
Symptom improvement
\>50% improvement in symptoms and decrease in frequency of voids and episodes of nocturia. Subjective outcomes will be measured by improvement in scores on the UDI-6, KHG, and MBIS.
Time frame: 3 months
The record gives a start of Mar 2011, a primary completion of Apr 2016 and a completion of Apr 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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