Two Devices for Reflex Voiding Following Spinal Cord Injury

NCT00662207 | Completed Phase 1 Results

• 1 other identifier: B6176-R
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injury; Urinary Incontinence

Keywords

electric stimulation; urethral obstruction; urodynamics; urology

Outcome Measures

Primary Outcomes (4)

• Number of Participants With a Change in Bladder Pressure

  Measured via pressure catheter in bladder with a pressure transducer

  3 hour recording session

• Number of Participants With a Change in External Urethral Pressure

  Measured via balloon catheter

  3 hour recording session

• Number of Participants With a Change in Anal Sphincter Pressure

  Measured via balloon catheter

  3 hour recording session

• Number of Participants With a Urethral Sphincter Contractions

  3 hour recording session

Study Arms (1)

Arm 1

EXPERIMENTAL

Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; Use an anal dilator to determine if urethral relaxation will occur

Device: Vibrator; Procedure: Anal dilator

Interventions

Vibrator DEVICE

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

Also known as: perinuem vibrator

Arm 1

Anal dilator PROCEDURE

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

Also known as: Modified rectal balloon for anal dilation

Arm 1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

Edward Hines, Jr. VA Hospital

Hines, Illinois, 60141-5000, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Urinary Incontinence; Urethral Obstruction

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Urination Disorders; 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; Urethral Diseases

Results Point of Contact

• Title: James S. Walter, Ph.D.
• Organization: Hines VA Hospital, Research Service

James.Walter@va.gov

708-202-5805

Study Officials

• James Walter, PhD

  Edward Hines Jr. VA Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 21, 2008
• Study Start: October 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: November 5, 2014
• Results First Posted: November 5, 2014

Record last verified: 2014-11

Locations

US (1)