Vaginal Electrical Stimulation Versus Neuromodulation

NCT01525485 | Completed

• 1 other identifier: 1104
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Study Arms (2)

Electrical Stimulation

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.

Interstim device

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.

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• S. Abbas Shobeiri, MD

  Univerisity of Oklahoma Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2012
• First Posted: February 3, 2012
• Study Start: March 1, 2011
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 9, 2016

Record last verified: 2016-06

Locations

US (1)