Phase 1 N=3 Basic Science

Two Devices for Reflex Voiding Following Spinal Cord Injury

Spinal Cord Injury · Urinary Incontinence

Bottom Line

View on ClinicalTrials.gov: NCT00662207 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2014

Primary outcome: Primary: Number of Participants With a Change in Bladder Pressure — 0 participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Vibrator (Device); Anal dilator (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: US Department of Veterans Affairs
Primary completion: Oct 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With a Change in Bladder Pressure	—	—
PRIMARY Number of Participants With a Change in External Urethral Pressure	—	—
PRIMARY Number of Participants With a Change in Anal Sphincter Pressure	—	—
PRIMARY Number of Participants With a Urethral Sphincter Contractions	—	—

Summary

The purpose of this investigation is to evaluate methods in spinal cord injured individuals to improve reflex urination. Anal dilation will be investigated to reduce high urethral resistance and a vibrator on the patient's bottom will be tested to induce more sustained bladder contractions for better bladder emptying.

Eligibility Criteria

Inclusion Criteria

Male Veterans using Hines VA Hospital SCI Service that have upper motor neuron injuries

Exclusion Criteria

Can voluntarily control their urination
Surgically removed external urethral sphincter in men or replaced bladder
Any implanted devices in the lower urinary tract
Female
Urinary tract infection in the prior 3 months or untreated urinary tract infection, or bladder pathology such as a tumor or stones
History of autonomic dysreflexia
Anal inflammation or pathology
Use of Indwelling (Foley) catheter as the primary method of bladder management; note patients will be included if they only occasionally use a Foley catheters; for example, during traveling
Not under 18 or over 70 years old and in good health
Less than 3-months after injury and before the return of bladder reflexes
Lower motor neuron spinal cord injury
Not competent to understand the study and the consent and willing to participate in study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00662207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.