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Device

Low Level Laser Therapy for Bowel Incontinence (LLLT-FI Trial)

N/A

Recruiting

Led By Jihong Chen, MD PhD

Research Sponsored by McMaster University

Eligibility Criteria Checklist

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

Must have

Patients with fecal incontinence

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 and 12 weeks

Awards & highlights

LLLT-FI Trial Summary

This trial is testing whether a low level laser therapy can help patients with severe, uncontrollable fecal incontinence. There is no control group receiving a placebo in this study.

Who is the study for?

This trial is for individuals with severe fecal incontinence, which means they have trouble controlling their bowel movements. It's not open to pregnant people, those on steroids, anyone with active deep vein thrombosis or bleeding in the treatment area, light-sensitive patients, or if there are tattoos or known cancers where the therapy will be applied.Check my eligibility

What is being tested?

The study is testing low level laser therapy (LLLT) to see if it helps patients with severe refractory fecal incontinence. There isn't a placebo group being compared against; this is an initial test of the concept to understand its effects.See study design

What are the potential side effects?

Since LLLT doesn't involve drugs and uses low-intensity lasers, side effects might include local skin irritation at the site of application. However, specific side effect profiles will be studied as part of this trial.

LLLT-FI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I experience loss of bowel control.

LLLT-FI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 and 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 and 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 and 12 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in number of fecal incontinence episodes

Secondary outcome measures

Change in Quality of Life

Change in anal sphincter tone

Change in increase of anal sphincter pressure during squeezing

+2 more

LLLT-FI Trial Design

1Treatment groups

Experimental Treatment

Group I: Incontinence and low level laser therapyExperimental Treatment1 Intervention

Intervention: Low level laser therapy (sacral neuromodulation or photobiomodulation) will be administered to patients with fecal incontinence

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Low level laser therapy (LLLT)

2021

N/A

~200

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor

881 Previous Clinical Trials

2,597,866 Total Patients Enrolled

Jihong Chen, MD PhDPrincipal InvestigatorMcMaster University

1 Previous Clinical Trials

20 Total Patients Enrolled

Media Library

Low level laser therapy (LLLT) (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03825575 — N/A

Bowel Incontinence Clinical Trial 2023: Low level laser therapy (LLLT) Highlights & Side Effects. Trial Name: NCT03825575 — N/A

Bowel Incontinence Research Study Groups: Incontinence and low level laser therapy

Low level laser therapy (LLLT) (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03825575 — N/A

Frequently Asked Questions

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

What is the current enrollment count of this research experiment?

"Affirmative. The study, which was posted on September 8th 2019 and last updated April 4th 2022 is actively recruiting patients according to clinicaltrials.gov reports. A total of 20 individuals are needed for the trial at 1 location."

Answered by AI

Are new participants still being received into this experiment?

"Yes, records on clinicaltrials.gov demonstrate that this study is presently recruiting patients. Originally posted in September of 2019 and revised last April 4th 2022; the trial has a target enrolment of 20 participants from 1 medical centre."

Answered by AI

Under what circumstances would an individual qualify for inclusion in this investigation?

"The criteria for enrollment in this trial is limited to individuals within the age range of 6 and 80 who are affected by fecal soiling. Approximately 20 participants need to be recruited."

Answered by AI

Is this trial open to adults aged 25 and over?

"According to the trial's eligibilty guidelines, potential participants must have a chronological age of between 6 and 80 years old. Additionally, there are 7 study groups for minors and 23 dedicated research tracks available for those aged 65 or older."

Answered by AI

Recent research and studies

Diseases of the Colon & RectumJournal

Systematic Review of Surgical Treatments for Fecal Incontinence

Forte, Mary L., Kate E. Andrade, Ann C. Lowry, Mary Butler, Donna Z. Bliss, and Robert L. Kane. 2016. “Systematic Review of Surgical Treatments for Fecal Incontinence”. Diseases of the Colon & Rectum. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/dcr.0000000000000594.

Diseases of the Colon & RectumJournal

Fecal Incontinence Quality of Life Scale

Rockwood, Todd H., James M. Church, James W. Fleshman, Robert L. Kane, Constantinos Mavrantonis, Alan G. Thorson, Steven D. Wexner, Donna Bliss, and Ann C. Lowry. 2000. “Fecal Incontinence Quality of Life Scale”. Diseases of the Colon & Rectum. Ovid Technologies (Wolters Kluwer Health). doi:10.1007/bf02237236.

GutJournal

Prospective Comparison of Faecal Incontinence Grading Systems

Vaizey, C J, E Carapeti, J A Cahill, and M A Kamm. 1999. “Prospective Comparison of Faecal Incontinence Grading Systems”. Gut. BMJ. doi:10.1136/gut.44.1.77.

clinicaltrials.govStudy