NCT02992509

IVES for Treatment of UUI and OAB

EMED Detruset Intravesical Electrical Stimulation Catheter for Treatment of Urge Urinary Incontinence and Overactive Bladder Syndrome in Females

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Loma Linda University · Academic / Other
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Conditions

• Urinary Bladder, Overactive
• Urinary Incontinence, Urge

Interventions

Type	Name	Description
DEVICE	EMED detruset(TM) intravesical electrical stimulation	There will be 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. The electrical parameters utilized will be those previously determined to be appropriate for OAB and UUI. As the beneficial effect of electrical stimulation is dependent on a "maximal" level of stimulation, the stimulation voltage will be increased during the first minute of treatment until the maximum tolerated by the patient is established and then backed-off by 1-2 Volts. The therapy will continue for 15 minutes in total for each session. The VAS will be marked by the patient before each treatment session throughout the therapy period, and other questionnaires will be administered.

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-11-01
• First posted: 2016-12-14
• Last updated: 2017-01-04

Locations

1 site across 1 country: United States