Health TrialsbyHealthPanel

Device for Bladder Control for Men With SCI

ConditionNeurogenic Bladder
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Suprasacral SCI

Neurologically stable

Skeletally mature

Presence of reflex bladder contractions

Disqualifiers

Active sepsis

Open pressure sores on or around pelvis

Bleeding diathesis

Significant urethral trauma, erosion, or stricture

Trial design

Design model

Single group

Treatments tested in this trial

  • Noninvasive electrical stimulation device to improve bladder control

    Device

    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.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Genital Nerve StimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Bladder Capacity

Change in bladder capacity (in mL) in response to genital nerve stimulation will serve as the primary outcome measure for this study.

Time frame
Day 1

Secondary outcomes

1

Usability Metrics

Study participants will be surveyed regarding device design and usability prior to device usage.

Time frame
Day 1
2

Electrical Impedance

The Gravata's electrode to skin contact will be assessed through measuring electrical impedance of the device to confirm adherence to out benchmark (less than 4 kOhms)

Time frame
Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: