IVES for Treatment of UUI and OAB

Urinary Bladder, Overactive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02992509
• Other study ID #: 5130321
• Status: Completed
• Phase: Phase 0
• First received: December 12, 2016
• Last updated: December 30, 2016
• Start date: December 2014

Study information

• Verified date: December 2016
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enuresis
• Urinary Bladder, Overactive
• Urinary Incontinence
• Urinary Incontinence, Urge

Intervention

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.

Locations

Country	Name	City	State
United States	Loma Linda University Health	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & Publications (4)

Cheng EY, Richards I, Balcom A, Steinhardt G, Diamond M, Rich M, Donovan JM, Carr MC, Reinberg Y, Hurt G, Chandra M, Bauer SB, Kaplan WE. Bladder stimulation therapy improves bladder compliance: results from a multi-institutional trial. J Urol. 1996 Aug;156(2 Pt 2):761-4. — View Citation

Hagerty JA, Richards I, Kaplan WE. Intravesical electrotherapy for neurogenic bladder dysfunction: a 22-year experience. J Urol. 2007 Oct;178(4 Pt 2):1680-3; discussion 1683. — View Citation

Hong CH, Lee HY, Jin MH, Noh JY, Lee BH, Han SW. The effect of intravesical electrical stimulation on bladder function and synaptic neurotransmission in the rat spinal cord after spinal cord injury. BJU Int. 2009 Apr;103(8):1136-41. doi: 10.1111/j.1464-410X.2008.08189.x. — View Citation

Lombardi G, Musco S, Celso M, Ierardi A, Nelli F, Del Corso F, Del Popolo G. Intravesical electrostimulation versus sacral neuromodulation for incomplete spinal cord patients suffering from neurogenic non-obstructive urinary retention. Spinal Cord. 2013 Jul;51(7):571-8. doi: 10.1038/sc.2013.37. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in incontinence	Primary endpoint is a reduction in incontinence events at 3 months post treatment as determined by a 7 point patient global impression of improvement	3 months	No