Two Devices for Reflex Voiding Following Spinal Cord Injury

• ClinicalTrials.gov Identifier: NCT00662207
• Recruitment Status: Completed
• First Posted: April 21, 2008
• Results First Posted: November 5, 2014
• Last Update Posted: November 5, 2014
• Sponsor: US Department of Veterans Affairs
• Information provided by (Responsible Party): VA Office of Research and Development ( US Department of Veterans Affairs )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Spinal Cord Injury; Urinary Incontinence	Device: Vibrator; Procedure: Anal dilator	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Two Devices for Reflex Voiding Following SCI: Urodynamic Evaluation
• Study Start Date: October 2008
• Actual Primary Completion Date: October 2009
• Actual Study Completion Date: October 2009

Arms and Interventions

Arm

Intervention/treatment

Experimental: Arm 1; 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; A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction; Other Name: perinuem vibrator; 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. An anal dilator is being conduced with the balloon; Other Name: Modified rectal balloon for anal dilation

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With a Change in Bladder Pressure [ Time Frame: 3 hour recording session ]
   Measured via pressure catheter in bladder with a pressure transducer
2. Number of Participants With a Change in External Urethral Pressure [ Time Frame: 3 hour recording session ]
   Measured via balloon catheter
3. Number of Participants With a Change in Anal Sphincter Pressure [ Time Frame: 3 hour recording session ]
   Measured via balloon catheter
4. Number of Participants With a Urethral Sphincter Contractions [ Time Frame: 3 hour recording session ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Illinois

Edward Hines, Jr. VA Hospital

Hines, Illinois, United States, 60141-5000

Sponsors and Collaborators

US Department of Veterans Affairs

Investigators

• Principal Investigator: James Walter, PhD; Edward Hines Jr. VA Hospital

More Information

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00662207
• Other Study ID Numbers: B6176-R
• First Posted: April 21, 2008
• Results First Posted: November 5, 2014
• Last Update Posted: November 5, 2014
• Last Verified: November 2014

Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):

electric stimulation; urethral obstruction; urodynamics; urology

Additional relevant MeSH terms:

Spinal Cord Injuries; Urinary Incontinence; Wounds and Injuries; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations