Two Devices for Reflex Voiding Following Spinal Cord Injury
Condition: Spinal Cord Injury; Urinary Incontinence
MeSH terms: Spinal Cord Injuries; Urinary Incontinence
Study type: Interventional
Phase: Phase 1

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.

      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.
    

Intervention name(s): Vibrator; Anal dilator
Intervention type(s): Device; Procedure
Intervention description(s): A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction; 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 intervention name(s): perinuem vibrator; Modified rectal balloon for anal dilation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: electric stimulation; urethral obstruction; urodynamics; urology