NCT01525485

Vaginal Electrical Stimulation Versus Neuromodulation

Vaginal Electrical Stimulation Versus Sacral Neuromodulation for the Treatment of Refractory Overactive Bladder: A Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 34 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: Female
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Refractory Overactive Bladder

Timeline

• Start date: 2011-03-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2012-02-03
• Last updated: 2016-06-09

Locations

1 site across 1 country: United States