IVES for Treatment of UUI and OAB

Early Phase 1

Completed

• Conditions: Urinary Bladder, Overactive; Urinary Incontinence, Urge
• Interventions: Device: EMED detruset(TM) intravesical electrical stimulation

• Registration Number: NCT02992509
• Lead Sponsor: Loma Linda University

Brief Summary

The pilot study is intended to show the efficacy of intravesical electrical stimulation in treating overactive bladder with or without frequency and/or urgency urinary incontinence.

Detailed Description

The EMED Technologies detrusetTM intravesical electrical stimulation (IVES) catheter is indicated for use with the EMED detrusanTM 500 electrical generator for the treatment of overactive bladder and urge urinary incontinence (UI) in women who are not satisfied with or cannot tolerate other conservative treatments. EMED is interested in conducting a prospective randomized multi-center study of IVES therapy vs conventional UI treatments. In order to gain sufficient knowledge of the treatment effect and variability of IVES therapy to power an RCT, a pilot study will be initially conducted.

The pilot study is intended to show the efficacy of IVES in treating overactive bladder with or without frequency and/or urgency urinary incontinence with safety profile of IVES being no worse than with standard urological catheters.

A primary endpoint at 3 months showing reduction in incontinence events via a 7-level patient global impression of improvement will be established. Secondary endpoints will include PCI for subsets of symptoms, 3 day voiding diary, and patient satisfaction questionnaires.

Follow up at end of therapy and 3 months from the first therapy session will be conducted. 6-month, 9-month, and 12-month follow up can be conducted to establish durability of IVES therapy if it is found to be effective at 3 months after the first treatment

Study Timeline

• Study Start: 2014-12
• Primary Completion: 2015-11
• Status Verified: 2016-12
• Study First Submitted: 2016-12-12
• Study First Submitted QC: 2016-12-12
• Study First Posted: 2016-12-14
• Last Update Submitted: 2016-12-30
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 17

Inclusion Criteria

• Female
• 18-90 years old
• Urinary urge incontinence OR overactive bladder
• Prior trial of medical treatment for UUI or OAB

Exclusion Criteria

• pelvic organ prolapse greater than stage 1
• multiple sclerosis
• parkinson's disease
• spinal cord injury
• long-term DM type I
• prior surgeries that may affect innervation of the detrusor nerves or the spinal cord
• pregnancy
• pacemaker/defibrillator
• PVR >150ml
• dementia
• Stress urinary incontinence
• intravesical botox injection within 1 year, PTNS within 6 months, or medical treatment for OAB within 3 weeks; bulking agent injection within 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	EMED detruset(TM) intravesical electrical stimulation	This pilot study group is a prospective observational study. It is not blinded and there is no control. This is a single arm study (treatment group) which will receive intravesical electrical stimulation with a total of 8 therapy sessions, each lasting 15 minutes. The sessions will be done in a serial fashion, 2 per week for 4 consecutive weeks.

Primary Outcome Measures

Name	Time	Method
Reduction in incontinence	3 months	Primary endpoint is a reduction in incontinence events at 3 months post treatment as determined by a 7 point patient global impression of improvement

Trial Locations

Locations (1)

Loma Linda University Health; 🇺🇸 Loma Linda, California, United States