RecruitingNot ApplicableNCT03825575

Sacral Neuromodulation as Treatment for Fecal Incontinence


Sponsor

McMaster University

Enrollment

20 participants

Start Date

Sep 8, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 6 YearsMax Age: 80 Years

Inclusion Criteria1

  • Patients with fecal incontinence

Exclusion Criteria7

  • 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.

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Interventions

DEVICELow level laser therapy (LLLT)

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


Locations(1)

McMaster University

Hamilton, Ontario, Canada

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NCT03825575


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