Vaginal Electrical Stimulation Versus Neuromodulation

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Oklahoma
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01525485
First received: January 19, 2012
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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.


Condition
Refractory Overactive Bladder

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Vaginal Electrical Stimulation Versus Sacral Neuromodulation for the Treatment of Refractory Overactive Bladder: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Symptom improvement [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    >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.


Estimated Enrollment: 48
Study Start Date: March 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01525485

Contacts
Contact: Dena White, MD 405-271-8787

Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Dena White, MD    405-271-8787      
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: S. Abbas Shobeiri, MD Univerisity of Oklahoma Health Sciences Center
  More Information

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01525485     History of Changes
Other Study ID Numbers: Estim
Study First Received: January 19, 2012
Last Updated: May 5, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014