IVES for Treatment of UUI and OAB | Clinical Trial

Key information

Conditions

Urinary Bladder, Overactive Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Loma Linda University Health

Loma Linda, California, 92354, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EMED detruset(TM) intravesical electrical stimulation

Device

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.

Primary outcomes

Reduction in incontinence

Time frame: 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

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
First posted: Dec 14, 2016
Registry last updated: Jan 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed