CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 3 enrolled
Drug / intervention
Vibrator +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00662207
NCT00662207Phase 1Completed
CompareCT.gov

Two Devices for Reflex Voiding Following SCI: Urodynamic Evaluation

US Department of Veterans Affairs·interventional·Posted Apr 21, 2008·Updated Nov 5, 2014

In Brief

A Phase 1 clinical trial evaluating Vibrator and Anal dilator for Spinal Cord Injury and Urinary Incontinence. Completed, enrolled 3 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Cord Injury, Urinary Incontinence
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 21, 2008
Enrollment StartOct 1, 2008
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 18.2 years ago

Interventions

Vibratordevice

A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction

Anal dilatorprocedure

A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter. An anal dilator is being conduced with the balloon