Recruiting

Sacral Neuromodulation

Sponsor:

McMaster University

Code:

NCT03825575

Conditions

Fecal Incontinence

Eligibility Criteria

Sex: All

Age: 6 - 70+

Healthy Volunteers: Not accepted

Interventions

Low level laser therapy (LLLT)

Study Details

Brief summary:

The objective of this study is to investigate if low level laser therapy will do more good than harm for patients with severe refractory fecal incontinence. It is a proof of concept study without a placebo arm.

Conditions

Fecal Incontinence

Study ID

NCT03825575

Start date

Sep 8, 2019

Status verified date

Apr, 2022

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Feb 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patients with fecal incontinence

Exclusion Criteria:

  • Pregnant patients
  • Known malignancies in the area of treatment
  • Active bleeding in area of treatment
  • Active deep vein thrombosis
  • When tatoos are present at area of treatment
  • Patients that are light sensitive
  • Patients who take steroids.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Incontinence and low level laser therapy

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

Interventions

Low level laser therapy (LLLT)

A 3 week treatment period with a total of 8 treatments of 1 hour over the sacral spinal cord

Primary outcome measure

  • Change in number of fecal incontinence episodes [ Time Frame: 4 weeks and 12 weeks ]

Central Contacts and Locations

Central contacts

Jihong Chen, MD PhD

1-226-3439909chen338@mcmaster.ca

Jan D Huizinga, PhD

1-226-3438888huizinga@mcmaster.ca

Locations

McMaster University

Recruiting

Hamilton, Ontario, Canada, L8N3Z5

Contacts

Jihong Chen, MD PhD

chen338@mcmaster.ca

More Information

Sponsor

McMaster University

Last update posted

Apr 5, 2022

Last verified

Apr, 2022

Keywords

  • Fecal Incontinence
  • Anorectal manometry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2022-04-05.