Study 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.
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: 4 and 12 weeks
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
1 Treatment Group
Incontinence and low level laser therapy
1 of 1
Experimental Treatment
20 Total Participants · 1 Treatment Group
Primary Treatment: Low level laser therapy (LLLT) · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 6 - 80 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- 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.
- 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.
- 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.
- 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/
- 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.
- 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.
- Jihong Chen 2019. "Sacral Neuromodulation as Treatment for Fecal Incontinence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03825575.
Frequently Asked Questions
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor