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Two Devices for Reflex Voiding Following Spinal Cord Injury
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, December 2008
First Received: April 1, 2008   Last Updated: December 30, 2008   History of Changes
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00662207
  Purpose

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.


Condition Intervention Phase
Spinal Cord Injury
Urinary Incontinence
Device: Vibrator
Procedure: Anal dilator
Phase I

MedlinePlus related topics: Spinal Cord Injuries Urinary Incontinence Urine and Urination
U.S. FDA Resources
Study Type: Interventional
Study Design: Basic Science, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: Two Devices for Reflex Voiding Following SCI: Urodynamic Evaluation

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Bladder pressure increase [ Time Frame: during a few minutes of testing ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: October 2008
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dialtor of the anus to determine if urethral relaxation will occur
Device: Vibrator
A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction
Procedure: Anal dilator
A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter

Detailed Description:

Catheters are often used by individuals emptying their bladder following spinal cord injury. Reflex voiding is one of the bladder emptying methods, and it relies on spontaneous bladder contractions for voiding. These contractions occur with normal bladder filling or can be induced with suprapubic tapping and hair pulling. Poor voiding responses with reflex voiding can occur because of unwanted contractions of the urethra during bladder contractions and/or unsustained bladder contractions that result in high residual urine. The focus of this investigation is methods to reduce the high urethral resistance and to induce more sustained bladder contractions. Obj.1. Measure pelvic floor contractile activity including the pelvic floor relaxation response (urethral and anal pressures, and EMG and the bulbocavernosus reflex) during dilation of the anus with digits or a balloon for 60 sec at diameters of 2, 3.5 and 5 cm.

Obj. 2. Measure urodynamic parameters (urethral and anal pressures, EMG, urine flow rates and bladder pressure) and compare three somatic methods of inducing bladder contractions, which are vibration (3 mm conducted at 100 strokes per second) at suprapubic and perineum (between the scrotum and anus) locations and tapping/suprapubic hair pulling. Conduct procedures using 80% of cystometric capacity and define a responder to any of the three interventions as an increase of 10 cm H20 pressure or greater. For nonresponders go to objective 4.

Obj. 3. For responders to Ob. 2, further evaluate effects of perineum vibration by conducting comparisons with (1) anal dilation to no dilation; (2) A vibration stroke length of 1.5 mm to 3 mm; (3) A bladder volume of 50% cystometric capacity to 80%.

Obj. 4. Compare the urodynamic responses to spontaneous bladder contractions induced by bladder filling (cystometry) with and without anal dilation.

Obj. 5. Conduct a human factors assessment. Determine problems with use of the current perineum vibration and anal dilation devices. Evaluate if curving the tip of the insertion device for the anal dilator would facilitate insertion and if the use of a plastic bag would improve hygiene. Discuss features important for a user-friendly home-use device. Design & Methods: All objectives will be conducted during a single, urodynamic, testing protocol. Fifteen male SCI patients with upper-motor-neuron injuries will be enrolled. Urodynamic responses are our primary measure. These include urethral and anal sphincter pressures and anal surface EMG, bladder contractions including peak pressure and duration of pressure, voiding responses including peak voiding rate and duration of voiding. These measures will be evaluated during anal dilation and perineum vibration methods alone and in combination. Anal dilation protocols will include random and duplicated testing. Vibration methods will only be done once to limit the risk of autonomic dysreflexia. Analysis of variance followed by Student-Neuman-Keuls post hoc test will be conducted to assess significant differences.

Importance of Findings: Results from these studies will provide evidence for anal dilation to reduce DSD and perineum vibration to improve bladder contractions. Thus, these studies could provide important evidence for improved methods of RV for individuals with SCI. During this pilot study, subjects will not be counseled to conduct RV for their daily or regular bladder management program.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Can voluntarily control their urination
  2. Surgically removed external urethral sphincter in men or replaced bladder
  3. Any implanted devices in the lower urinary tract
  4. Female
  5. Urinary tract infection in the prior 3 months or untreated urinary tract infection, or bladder pathology such as a tumor or stones
  6. History of autonomic dysreflexia
  7. Anal inflammation or pathology
  8. 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
  9. Not under 18 or over 70 years old and in good health
  10. Less than 3-months after injury and before the return of bladder reflexes
  11. Lower motor neuron spinal cord injury
  12. Not competent to understand the study and the consent and willing to participate in study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00662207

Contacts
Contact: James Walter, PhD (708) 202-8387 ext 25805 james.walter@va.gov

Locations
United States, Illinois
Edward Hines, Jr. VA Hospital Recruiting
Hines, Illinois, United States, 60141-5000
Contact: James Walter, PhD     708-202-8387 ext 25805     james.walter@va.gov    
Principal Investigator: James Walter, PhD            
Sponsors and Collaborators
Investigators
Principal Investigator: James Walter, PhD Edward Hines Jr. VA Hospital
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs ( Walter, James - Principal Investigator )
Study ID Numbers: B6176R
Study First Received: April 1, 2008
Last Updated: December 30, 2008
ClinicalTrials.gov Identifier: NCT00662207     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
electric stimulation
urethral obstruction
urodynamics
urology

Study placed in the following topic categories:
Signs and Symptoms
Spinal Cord Injuries
Spinal Cord Diseases
Urologic Diseases
Urination Disorders
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases
Urinary Incontinence
Trauma, Nervous System

Additional relevant MeSH terms:
Signs and Symptoms
Urological Manifestations
Spinal Cord Injuries
Spinal Cord Diseases
Urologic Diseases
Urination Disorders
Nervous System Diseases
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases
Urinary Incontinence
Trauma, Nervous System

ClinicalTrials.gov processed this record on May 07, 2009