Two Devices for Reflex Voiding Following SCI: Urodynamic Evaluation
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Number of Participants With a Urethral Sphincter Contractions
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
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
Intervention: Vibrator (Device)
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
Intervention: Anal dilator (Procedure)
Outcomes
Primary Outcomes
Number of Participants With a Urethral Sphincter Contractions
Time Frame: 3 hour recording session
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
Number of Participants With a Change in Anal Sphincter Pressure
Time Frame: 3 hour recording session
Measured via balloon catheter
Number of Participants With a Change in External Urethral Pressure
Time Frame: 3 hour recording session
Measured via balloon catheter
Secondary Outcomes
No secondary outcomes reported