IVES for Treatment of UUI and OAB

NCT02992509 | Completed Early Phase 1 DMC

• 1 other identifier: 5130321
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Treatment

OTHER

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.

Device: EMED detruset(TM) intravesical electrical stimulation

Interventions

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.

Treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Health

Loma Linda, California, 92354, United States

Location

Related Publications (4)

• 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. doi: 10.1016/j.juro.2007.03.188. Epub 2007 Aug 17.

  PMID: 17707024 BACKGROUND

• 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.

  PMID: 8683778 BACKGROUND

• 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. Epub 2008 Nov 18.

  PMID: 19021629 BACKGROUND

• 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. Epub 2013 Apr 30.

  PMID: 23628893 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

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

Study Officials

• Sam Siddighi, MD

  Loma Linda University Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urogynecology/Pelvic Surgery, FPMRS

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: December 14, 2016
• Study Start: December 1, 2014
• Primary Completion: November 1, 2015
• Last Updated: January 4, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)