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NCT Number: NCT03825575

Sacral Neuromodulation as Treatment for Fecal Incontinence

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.

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Key information

Conditions

Fecal Incontinence Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

6 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University

Hamilton, Ontario, L8N3Z5, Canada

Location status: Recruiting

Location contact

Jihong Chen, MD PhD

CONTACT

[email protected]

About this study

The therapy consists of a 3 week treatment with a total of 8 sessions of low level laser therapy. Effects will be assessed using symptoms and quality of life questionnaires and physiological assessments of pelvic floor function, at 4 weeks and 12 weeks after beginning of treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low level laser therapy (LLLT)

Device

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

Other names: Sacral neuromodulation, Photobiomodulation, BioFlex laser stimulation

Primary outcomes

  1. Change in number of fecal incontinence episodes

    Time frame: 4 weeks and 12 weeks

    Number of fecal incontinence episodes per week

Secondary outcomes

  1. Change in Quality of Life

    Time frame: 4 weeks and 12 weeks

    The Fecal Incontinence Quality of Life Assessment is a subject-completed questionnaire. It is measured in each of four areas of depression/self-perception (7 items), lifestyle (10 items), coping (9 items), and embarrassment (3 items). Area scores are measured on a 1 (worse) to 4 (best) scale and are each the average of their component individual item scores measured on the same scale. The total score is the mean of all non-missing items. A negative change from baseline indicates improvement. Minimum important difference is 4 (Forte et al., 2016)

  2. Change in symptoms score

    Time frame: 4 and 12 weeks

    St. Mark's Incontinence (Vaizey) Score, it is a scale from 0-24 where 0=perfect continence and 24 is complete continence. Minimal important difference is 3 (Forte et al., 2016)

  3. Change in anal sphincter tone

    Time frame: 12 weeks

    Anal sphincter tone (mmHg)

  4. Change in increase of anal sphincter pressure during squeezing

    Time frame: 12 weeks

    Difference between anal sphincter squeeze pressure and resting pressure (mmHg)

  5. Change in squeezing duration

    Time frame: 12 weeks

    Anal sphincter sustained squeezing duration (seconds)

Study contacts

Contact information is provided by the study sponsor or research team.

Jan D Huizinga, PhD

CONTACT

[email protected]

1-226-3438888

Jihong Chen, MD PhD

CONTACT

[email protected]

1-226-3439909

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Acronym: LLLT-FI

Important dates

Study start
2019
Primary completion
2025
Study completion
2027
First posted
Jan 31, 2019
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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