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Primary for Bowel Incontinence

Q: What are the eligibility criteria for individuals interested in participating in this research project?

Patients eligible for inclusion in this research should exhibit neurogenic bowel dysfunction and fall within the age range of 18 to 89 years. The study aims to recruit a total of 6 participants.

Q: Is the research open to participants above 60 years old?

Individuals aged 18 years and above but below 89 are eligible for enrollment in this clinical trial.

Q: Is the enrollment for this trial currently open?

As per clinicaltrials.gov, recruitment for this trial is ongoing. Its initial posting was on March 22nd, 2022 and the most recent update occurred on April 1st, 2024.

Q: What is the current number of individuals being enrolled in this research investigation?

Indeed, the details on clinicaltrials.gov imply that this research study is actively seeking volunteers. The trial was initially posted on March 22nd, 2022 and last modified on April 1st, 2024. It aims to recruit six participants from a single site.

Phase < 1

Recruiting

Led By Christopher P Cardozo, MD

Research Sponsored by James J. Peters Veterans Affairs Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 hours post neostigmine and glycopyrrolate administration

Awards & highlights

Study Summary

This trial aims to develop a new method to treat bowel dysfunction in individuals with spinal cord injury. The researchers have created a dual drug combination that can help safely and predictably empty the bowels. They

Who is the study for?

This trial is for individuals with spinal cord injury who experience neurogenic bowel disorders, including bowel incontinence and constipation. Participants should be those seeking a non-invasive method to induce bowel evacuation.Check my eligibility

What is being tested?

The study tests a wireless iontophoresis device called I-Box by Dynatronics, which delivers a combination of drugs (Neostigmine and Glycopyrrolate) through the skin using electrical current to promote bowel movement without needles.See study design

What are the potential side effects?

Potential side effects may include local skin reactions at the site of drug administration, possible mild discomfort from the device, and systemic effects related to Neostigmine and Glycopyrrolate such as dry mouth or dizziness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 hours post neostigmine and glycopyrrolate administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 hours post neostigmine and glycopyrrolate administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 hours post neostigmine and glycopyrrolate administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Presence or absence of bowel evacuation

Stool Consistency

Stool Quantity

+1 more

Secondary outcome measures

Presence or absence of headache, dry mouth, muscle twitching and abdominal cramps

Trial Design

1Treatment groups

Experimental Treatment

Group I: PrimaryExperimental Treatment2 Interventions

6 subjects will receive 2 medications transdermally.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

James J. Peters Veterans Affairs Medical CenterLead Sponsor

57 Previous Clinical Trials

2,894 Total Patients Enrolled

Christopher P Cardozo, MDPrincipal InvestigatorJames J. Peters Veterans Affairs Medical Center

3 Previous Clinical Trials

58 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility criteria for individuals interested in participating in this research project?

"Patients eligible for inclusion in this research should exhibit neurogenic bowel dysfunction and fall within the age range of 18 to 89 years. The study aims to recruit a total of 6 participants."

Answered by AI

Is the research open to participants above 60 years old?

"Individuals aged 18 years and above but below 89 are eligible for enrollment in this clinical trial."

Answered by AI

Is the enrollment for this trial currently open?

"As per clinicaltrials.gov, recruitment for this trial is ongoing. Its initial posting was on March 22nd, 2022 and the most recent update occurred on April 1st, 2024."

Answered by AI

What is the current number of individuals being enrolled in this research investigation?

"Indeed, the details on clinicaltrials.gov imply that this research study is actively seeking volunteers. The trial was initially posted on March 22nd, 2022 and last modified on April 1st, 2024. It aims to recruit six participants from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transdermal Administration by a Novel Wireless Iontophoresis Device

Chris Cardozo 2022. "Transdermal Administration by a Novel Wireless Iontophoresis Device". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06351852.

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