Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury

Technology

Bowel health

Online since 27 June 2023, updated 386 days ago

About this trial

Bowel function following SCI is a high priority for individuals living with SCI. This trial is enrolling individuals with chronic spinal cord injury at the cervical or thoracic level to test the effect of genital nerve stimulation (GNS) on the activity of the anus and rectum, to assess bowel function. If selected, participants will receive GNS applied briefly to determine if they qualify for the study. If qualified, participants will then receive: 1) active electrical stimulation applied to the genital nerve with surface electrodes; and 2) sham stimulation in a random order. Participants will also undergo ano-rectal manometry (ARM) to test anal and rectal function in response to the stimulation.

Included participants

Gender

All

Age

≥ 18 years

Injury level

C1 - T12

Severity (AIS)?

AIS-A

AIS-B

AIS-C

AIS-D

Time since injury

≥ 6 months

Injury type

Traumatic

Healthy volunteers

C1-T12

Additionally, participants must

NOT have cardiac pacemaker other implanted FES device

What’s involved

Type

Technology

Details

- One or two study visits (for a total of about 7.5 hours) - In visit 1, participants will receive GNS applied briefly to determine if they qualify for the study. - In visit 2, participants will receive 1) active electrical stimulation applied to the genital nerve with surface electrodes and 2) sham stimulation in a random order. - Ano-rectal manometry (ARM) to test how the anus and rectum are functioning in response to the stimulation

Potential benefits

Main benefits

Bowel health

Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

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