Sacral Neuromodulation as Treatment for Fecal Incontinence

NCT ID: NCT03825575

Last Updated: 2022-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-08

Study Completion Date

2027-02-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fecal Incontinence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Proof of concept
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Incontinence and low level laser therapy

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

Group Type EXPERIMENTAL

Low level laser therapy (LLLT)

Intervention Type DEVICE

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

Interventions

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Low level laser therapy (LLLT)

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

Intervention Type DEVICE

Other Intervention Names

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Sacral neuromodulation Photobiomodulation BioFlex laser stimulation

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Jihong Chen

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jihong Chen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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McMaster University

Hamilton, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Jihong Chen, MD PhD

Role: CONTACT

1-226-3439909

Jan D Huizinga, PhD

Role: CONTACT

1-226-3438888

Facility Contacts

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Jihong Chen, MD PhD

Role: primary

References

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Forte ML, Andrade KE, Butler M, Lowry AC, Bliss DZ, Slavin JL, Kane RL. Treatments for Fecal Incontinence [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2016 Mar. Report No.: 15(16)-EHC037-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK356097/

Reference Type BACKGROUND
PMID: 27099893 (View on PubMed)

Vaizey CJ, Carapeti E, Cahill JA, Kamm MA. Prospective comparison of faecal incontinence grading systems. Gut. 1999 Jan;44(1):77-80. doi: 10.1136/gut.44.1.77.

Reference Type BACKGROUND
PMID: 9862829 (View on PubMed)

Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7. doi: 10.1007/BF02237236.

Reference Type BACKGROUND
PMID: 10813117 (View on PubMed)

Other Identifiers

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McMasterChenFI

Identifier Type: -

Identifier Source: org_study_id

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