Device for Bladder Control for Men With SCI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Noninvasive electrical stimulation device to improve bladder control.
- Who it may be relevant to
- Registry conditions: Neurogenic Bladder. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Noninvasive Electrical Stimulation Device to Improve Bladder Control for Men With Spinal Core Injury
Overview
Urinary incontinence, bladder frequency, and bladder urgency are significant medical problems for people with overactive bladder (OAB) or neurogenic bladder overactivity (NDO). Affected individuals typically experience reflex bladder contractions in response to bladder filling at low volumes, resulting in urinary incontinence and decreased bladder capacity. This project will advance a new device for administering noninvasive electrical stimulation in order to improve bladder control.
Detailed description
Urinary incontinence, bladder frequency, and bladder urgency are significant medical problems for people with overactive bladder (OAB) or neurogenic bladder overactivity (NDO). Restoring bladder control is considered a high priority, but remains a critically unmet need requiring further development. The long-term goal is to develop and clinically implement a "bladder pacemaker" able to restore bladder control for individuals with OAB or NDO. Electrical stimulation of the genital nerves inhibits the spinal neural circuits involved in hyper-reflexive bladder spasms.
Genital nerve stimulation (GNS) has been used by multiple groups to inhibit reflexive OAB and neurogenic bladder contractions during acute (1 visit) urodynamic testing and limited chronic take-home testing. The investigators have recently demonstrated that surface GNS inhibits reflexive bladder contractions and reduces incontinence in individuals with SCI during one month of home use using a limited stimulation system. Participant feedback from these studies identified a number of stimulation system issues that created nontrivial inconveniences, which affected activities of daily living and prevented some participants from participating in the study. Required improvements include, but are not limited to better electrode interface, elimination of wired connections, and a smaller device.
The purposes of this proposal are to 1) develop and prototype a device for bladder control for men using GNS and 2) determine the acute effect of GNS on bladder capacity using this new prototype device. This work is building on previous success prototyping a similar device for women with OAB or NDO, which is being developed in other projects. The success of this study will be used to conduct a multi-site study of GNS and lead to clinical implementation.
Interventions
- Device Noninvasive electrical stimulation device to improve bladder control
Genital nerve stimulation (GNS) will be applied using a wearable, transcutaneous neurostimulator and sleeve electrode that targets the genital nerve reflex pathway for the treatment of neurogenic bladder associated with spinal cord injury.
Primary outcome measures
- Bladder Capacity [Time frame: Day 1]
Secondary outcome measures (2)
- Usability Metrics [Time frame: Day 1]
- Electrical Impedance [Time frame: Day 1]
Eligibility criteria
Inclusion criteria
- Suprasacral SCI
- Neurologically stable
- Skeletally mature
- Presence of reflex bladder contractions
- At least 12 months post SCI
Exclusion criteria
- Active sepsis
- Open pressure sores on or around pelvis
- Bleeding diathesis
- Significant urethral trauma, erosion, or stricture
- Indwelling catheter for over 1 year AND bladder capacity less than 100 mL
- Significant history of autonomic dysreflexia
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Louis Stokes VA Medical Center, Cleveland, OH — Cleveland
Identifiers
NCT: NCT07668063 · RRD5-001-25W · IU1RD000568-01A2