Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
NCT ID: NCT05626816
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
52 participants
INTERVENTIONAL
2023-03-21
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
At-Home Genital Nerve Stimulation for SCI Bowel
NCT06836739
Ambulatory Closed-loop Stimulation for Bladder Control
NCT05740527
Long Term Efficacy of Sacral Nerve Modulation (SNM) in Patients With Constipation or Stool Incontinence
NCT02836717
Electrical Control of Bladder in Spinal Cord Injury Patients
NCT00011570
Electrical Stimulation for Continence After Spinal Cord Injury
NCT02978638
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Minimizing barriers to participation:
1. \- If you live in the region (Cuyahoga, Lorain, Medina, Lake, or Geauga counties of Ohio) and need assistance with transportation to get to and from the research site for a visit, the study team will make these arrangements at no cost to you. If you live outside of the region, the study team will reimburse your transportation expenses up to a maximum of $556 per visit.
2. \- If you live a distance away from the research site for which it would be easier for you to spend the night closer for a research visit, accessible lodging is available at the Zubizarreta House. This house is right next door to the MetroHealth Rehabilitation Institute and is designed for people with spinal cord injuries. The overnight stay will be provided at no cost to you, but if you need a caregiver to stay with you that is your responsibility.
Visit 1 (screening): When a person decides to participate in the study they will be scheduled to come in for a screening visit. During this visit they will: provide informed consent to participate, participate in the initial screening exams, and have genital nerve stimulation (GNS) applied briefly to determine if the nerve responds to electrical stimulation.
If a person completes the screening procedures and qualifies for the study they will be invited back to complete the manometry visit.
Visit 2 (manometry):
1. \- Preparation: the participant will be asked to complete their typical bowel program the night before their manometry visit is scheduled. There are no restrictions on medications, eating, or drinking prior to the visit.
2. \- Instrumentation: the participant will have the study instrumentation applied.
3. \- Testing procedures with ARM and GNS: The London classification protocol will be used to assess ano-rectal function. This procedure uses a short (\~12 minutes) procedure of actions to determine how the anus and rectum are functioning.
Overall design: GNS and the London classification system will be used to assess bowel function in two different states, with stimulation and without stimulation. This will be applied in the order of no stimulation (condition A), stimulation (condition B), no stimulation (condition A repeated).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
All interventions, Sham applied first
These participants will have all interventions applied, but will be randomly designated to have sham stimulation applied before effective stimulation. This will balance any issue with order of presentation of multiple stimulation sessions.
Genital Nerve Stimulation
Electrical stimulation applied to the genital nerve with surface electrodes using an off the shelf TENS unit (Ultima Plus). First, an amplitude threshold for the pudendo-anal reflex responses will be determined. Then, sham (1-2 Hz) and effective stimulation (20 Hz) will be briefly applied to record responses. Then, stimulation will be applied in random presentation order to record any changes in anorectal manometry outcomes due to both sham and effective stimulation.
Clinical exam
Examination by physician determines the presence of pelvic reflexes (pudendo-anal and bulbocavernosus) which are essential for GNS to have an effect.
Collection of SCI common data elements
Data regarding participant demographics, history of injury, and medical history will be collected.
Bowel function survey completion
Two surveys will be conducted to assess the bowel function of the participant. The International SCI Bowel Function Basic Data Set (ISCI BF BDS v2.1) and the SCI Qulaity of Life Bowel Management Difficulties (SCI-QoL BMD) survey scales collect data on overall bowel function and how any difficulties impact the participants quality of life.
International Standard for Neurological Classification of SCI (ISNCSCI)
The physician will conduct the ISNCSCI to determine the level and severity of injury to the spinal cord. This is done by determining the ability to detect light touch and pinprick stimulation. Outcomes will be a Spinal Injury Association Impairment Scale (AIS) grade of A-D.
Response to genital nerve stimulation (GNS)
GNS will be applied to determine if there is a response in the participant. If the participant has no response to the stimulation they will be excluded from the second visit as it is dependent on the ability to respond to GNS.
Anorectal Manometry testing (ARM)
The participant will be instrumented for ARM testing. This requires a special balloon catheter to be inserted into the anus and secured, surface electrode pads being applied to the anal sphincter, and electrode pads being applied to the genital nerve stimulation sites.
Once instrumented, the participant will be tested with the London Classification procedure. This procedure asks the participant to perform several actions (squeeze to withhold a bowel movement, push to have a bowel movement, and cough) as well as inflating the balloon on the catheter to determine reflex thresholds (RAIR, retroanal inhibitory reflex which relaxes the anal sphincter in response to rectal distension) and sensory thresholds (first senstation,
All interventions, effective stim applied first
These participants will have all interventions applied, but will be randomly designated to have effective stimulation applied before sham stimulation. This will balance any issue with order of presentation of multiple stimulation sessions.
Genital Nerve Stimulation
Electrical stimulation applied to the genital nerve with surface electrodes using an off the shelf TENS unit (Ultima Plus). First, an amplitude threshold for the pudendo-anal reflex responses will be determined. Then, sham (1-2 Hz) and effective stimulation (20 Hz) will be briefly applied to record responses. Then, stimulation will be applied in random presentation order to record any changes in anorectal manometry outcomes due to both sham and effective stimulation.
Clinical exam
Examination by physician determines the presence of pelvic reflexes (pudendo-anal and bulbocavernosus) which are essential for GNS to have an effect.
Collection of SCI common data elements
Data regarding participant demographics, history of injury, and medical history will be collected.
Bowel function survey completion
Two surveys will be conducted to assess the bowel function of the participant. The International SCI Bowel Function Basic Data Set (ISCI BF BDS v2.1) and the SCI Qulaity of Life Bowel Management Difficulties (SCI-QoL BMD) survey scales collect data on overall bowel function and how any difficulties impact the participants quality of life.
International Standard for Neurological Classification of SCI (ISNCSCI)
The physician will conduct the ISNCSCI to determine the level and severity of injury to the spinal cord. This is done by determining the ability to detect light touch and pinprick stimulation. Outcomes will be a Spinal Injury Association Impairment Scale (AIS) grade of A-D.
Response to genital nerve stimulation (GNS)
GNS will be applied to determine if there is a response in the participant. If the participant has no response to the stimulation they will be excluded from the second visit as it is dependent on the ability to respond to GNS.
Anorectal Manometry testing (ARM)
The participant will be instrumented for ARM testing. This requires a special balloon catheter to be inserted into the anus and secured, surface electrode pads being applied to the anal sphincter, and electrode pads being applied to the genital nerve stimulation sites.
Once instrumented, the participant will be tested with the London Classification procedure. This procedure asks the participant to perform several actions (squeeze to withhold a bowel movement, push to have a bowel movement, and cough) as well as inflating the balloon on the catheter to determine reflex thresholds (RAIR, retroanal inhibitory reflex which relaxes the anal sphincter in response to rectal distension) and sensory thresholds (first senstation,
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Genital Nerve Stimulation
Electrical stimulation applied to the genital nerve with surface electrodes using an off the shelf TENS unit (Ultima Plus). First, an amplitude threshold for the pudendo-anal reflex responses will be determined. Then, sham (1-2 Hz) and effective stimulation (20 Hz) will be briefly applied to record responses. Then, stimulation will be applied in random presentation order to record any changes in anorectal manometry outcomes due to both sham and effective stimulation.
Clinical exam
Examination by physician determines the presence of pelvic reflexes (pudendo-anal and bulbocavernosus) which are essential for GNS to have an effect.
Collection of SCI common data elements
Data regarding participant demographics, history of injury, and medical history will be collected.
Bowel function survey completion
Two surveys will be conducted to assess the bowel function of the participant. The International SCI Bowel Function Basic Data Set (ISCI BF BDS v2.1) and the SCI Qulaity of Life Bowel Management Difficulties (SCI-QoL BMD) survey scales collect data on overall bowel function and how any difficulties impact the participants quality of life.
International Standard for Neurological Classification of SCI (ISNCSCI)
The physician will conduct the ISNCSCI to determine the level and severity of injury to the spinal cord. This is done by determining the ability to detect light touch and pinprick stimulation. Outcomes will be a Spinal Injury Association Impairment Scale (AIS) grade of A-D.
Response to genital nerve stimulation (GNS)
GNS will be applied to determine if there is a response in the participant. If the participant has no response to the stimulation they will be excluded from the second visit as it is dependent on the ability to respond to GNS.
Anorectal Manometry testing (ARM)
The participant will be instrumented for ARM testing. This requires a special balloon catheter to be inserted into the anus and secured, surface electrode pads being applied to the anal sphincter, and electrode pads being applied to the genital nerve stimulation sites.
Once instrumented, the participant will be tested with the London Classification procedure. This procedure asks the participant to perform several actions (squeeze to withhold a bowel movement, push to have a bowel movement, and cough) as well as inflating the balloon on the catheter to determine reflex thresholds (RAIR, retroanal inhibitory reflex which relaxes the anal sphincter in response to rectal distension) and sensory thresholds (first senstation,
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Minimum 6 months post-injury
* Aged 18 years or older
* Neurological level of injury T12 or higher AIS grade A-D defined by ISNCSCI
* Response to genital nerve stimulation upon screening
* Able to understand and provide informed consent
Exclusion Criteria
* Females who are pregnant or planning to become pregnant during the trial
* Presence of cardiac pacemaker, implanted defibrillator or other implanted FES device if, upon clinical exam, it may have an interaction with GNS.
* In the judgement of the PI or Co-Investigators, presence of medical complications that may interfere with the execution of the study.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
VA of Northeast Ohio Health System
UNKNOWN
Congressionally Directed Medical Research Programs
FED
MetroHealth Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Robert Hoey
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kim Anderson, PhD
Role: PRINCIPAL_INVESTIGATOR
MetroHealth Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
MetroHealth Medical System Old Brooklyn Campus
Cleveland, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CDMRP-SC210121P1
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CDMRP-SC210121
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STUDY00000105
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.