Vaginal Electrical Stimulation Versus Neuromodulation

Completed

• Conditions: Refractory Overactive Bladder

• Registration Number: NCT01525485
• Lead Sponsor: University of Oklahoma

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).

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2012-01-19
• Study First Submitted QC: 2012-01-31
• Study First Posted: 2012-02-03
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-08
• Last Update Posted: 2016-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptom improvement	3 months	\>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.

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States