Vaginal Electrical Stimulation Versus Neuromodulation

Refractory Overactive Bladder Clinical Trial

— Estim  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01525485
• Other study ID #: 1104
• Status: Completed
• Phase: N/A
• First received: January 19, 2012
• Last updated: June 8, 2016
• Start date: March 2011
• Est. completion date: April 2016

Study information

• Verified date: June 2016
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 99 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Refractory Overactive Bladder
• Urinary Bladder, Overactive

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No