Spinal Cord InjuryPhase 1NCT00662207
Two Devices for Reflex Voiding Following Spinal Cord Injury
A Phase 1 study testing Vibrator and Anal dilator in people with Spinal Cord Injury and Urinary Incontinence, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Spinal Cord Injury, Urinary Incontinence
- What is being tested?
- Vibrator and Anal dilator
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Oct 2009
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male Veterans using Hines VA Hospital SCI Service that have upper motor neuron injuries
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Edward Hines, Jr. VA Hospital
Hines, Illinois, 60141-5000
About this study
Official title: Two Devices for Reflex Voiding Following SCI: Urodynamic Evaluation
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.
Read the 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.
- Conditions
- Spinal Cord Injury, Urinary Incontinence
- Being tested
- Vibrator, Anal dilator
- Keywords
- electric stimulation, urethral obstruction, urodynamics, urology
- Medical subject headings
- Spinal Cord Injuries, Urinary Incontinence, Urethral Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VibratorDevice
Also called perinuem vibrator
A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction
Anal dilatorProcedure or surgery
Also called Modified rectal balloon for anal dilation
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Vibrator; Procedure: Anal dilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Change in Bladder Pressure
Measured via pressure catheter in bladder with a pressure transducer
Measured: 3 hour recording session
Number of Participants With a Change in External Urethral Pressure
Measured via balloon catheter
Measured: 3 hour recording session
Number of Participants With a Change in Anal Sphincter Pressure
Measured via balloon catheter
Measured: 3 hour recording session
Number of Participants With a Urethral Sphincter Contractions
Measured: 3 hour recording session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- James Walter, PhD, Principal investigator, Edward Hines Jr. VA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662207
- Sponsor's protocol ID
- B6176-R
- Status last verified
- Nov 2014
- First submitted
- 1 Apr 2008
- Last updated
- 5 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Devices for Reflex Voiding Following SCI: Urodynamic Evaluation
- ClinicalTrials.gov ID
- NCT00662207
- Acronym / sponsor ID
- B6176-R
- Conditions
- Spinal Cord Injury, Urinary Incontinence
- Keywords
- electric stimulation, urethral obstruction, urodynamics, urology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 21 Apr 2008 (estimated)
- Results
- Posted 5 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: Vibrator, Procedure: Anal dilatorUse 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male Veterans using Hines VA Hospital SCI Service that have upper motor neuron injuries
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VibratorAlso: perinuem vibratorA vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction | Device | Arm 1 |
| Anal dilatorAlso: Modified rectal balloon for anal dilationA 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 | Procedure or surgery | Arm 1 |
Primary outcome
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 External Urethral Pressure
Time frame: 3 hour recording session
Measured via balloon catheter
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 Urethral Sphincter Contractions
Time frame: 3 hour recording session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Walter, PhD principal investigator
Edward Hines Jr. VA Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vibrator and Anal dilator in people with Spinal Cord Injury and Urinary Incontinence, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Change in Bladder Pressure (time frame: 3 hour recording session). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2014.