Clinical trial NCT01525485: Vaginal Electrical Stimulation Versus Neuromodulation
Official title: Vaginal Electrical Stimulation Versus Sacral Neuromodulation for the Treatment of Refractory Overactive Bladder: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractory Overactive Bladder
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2012-02-03
Enrollment: 34
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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 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.

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 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).

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Symptom improvement
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: Univerisity of Oklahoma Health Sciences Center
name: S. Abbas Shobeiri, MD
role: PRINCIPAL_INVESTIGATOR
References: