Low Level Laser Therapy for Chronic Constipation

Recruiting in Palo Alto (17 mi)

Overseen by Jihong Chen, MD PhD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: McMaster University

Must not be taking: NSAIDS, Steroids

Disqualifiers: Pregnancy, Malignancies, Bleeding, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing if a special light therapy can help people with severe constipation that doesn't improve with other treatments. The therapy involves multiple sessions over a few weeks. It aims to improve how nerves and muscles in the digestive system work together. Researchers will check if symptoms and quality of life improve after the treatment.

Will I have to stop taking my current medications?

If you are taking NSAIDs (non-steroidal anti-inflammatory drugs) or steroids, you will need to stop taking them to participate in this trial.

What data supports the effectiveness of the treatment Sacral Neuromodulation for chronic constipation?

Research shows that sacral neuromodulation (a treatment that uses electrical impulses to stimulate nerves in the lower back) has been effective in treating constipation that doesn't respond to other treatments. Studies have found it to be a promising option for both adults and children with chronic constipation. ^{1 2 3 4 5}

Is sacral neuromodulation safe for treating chronic constipation?

Sacral neuromodulation (SNM) is generally considered safe for treating conditions like fecal and urinary incontinence, with some adverse events such as electrode movement and infection reported. While evidence for its use in constipation is limited, it is promising for certain patients, and a testing phase can help predict treatment outcomes. ^{5 6 7 8 9}

How is sacral neuromodulation different from other treatments for chronic constipation?

Sacral neuromodulation (SNM) is unique because it involves stimulating the sacral nerves, which can help regulate bowel function, and it is minimally invasive compared to other treatments. It has been used successfully in adults and is being explored for use in children, with ongoing research into optimizing its stimulation parameters for better outcomes. ^{2 4 10 11 12}

Research Team

Jihong Chen, MD PhD

Principal Investigator

McMaster University

Eligibility Criteria

This trial is for patients with severe chronic refractory constipation who have abnormal coordination between colonic motility and ano-rectal function, as shown by high resolution colonic manometry. It's not suitable for individuals with tattoos or light sensitivity in the treatment area, those taking NSAIDs or steroids, with malignancies or active bleeding in the treatment area, active deep vein thrombosis, or if pregnant.

Inclusion Criteria

My tests show my colon and rectum are not working together properly.

I have severe, long-lasting constipation that doesn't improve with treatment.

Exclusion Criteria

I am currently experiencing bleeding in the area that needs treatment.

I have cancer in the area where treatment is planned.

You are pregnant.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive low level laser therapy for severe refractory chronic constipation

3 weeks

8 sessions

Follow-up

Participants are monitored for changes in symptoms, quality of life, and physiological assessments

12 weeks

Treatment Details

Interventions

• Sacral Neuromodulation (Neuromodulation Device)

Trial Overview The study is testing low level laser therapy to see if it can help people with severe chronic constipation. This proof of concept study does not include a placebo group; all participants will receive the actual laser therapy to assess its effectiveness.

Participant Groups

Group I: Refractory Constipation with LLLT Experimental Treatment 1 Intervention

Low level laser therapy (LLLT) will be administered to patients with severe refractory chronic constipation

Sacral Neuromodulation is already approved in Canada for the following indications:

Approved in Canada as InterStim for:

• Overactive bladder
• Urinary urgency
• Frequency
• Urge incontinence
• Nonobstructive urinary retention
• Chronic fecal incontinence
• Chronic constipation

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Evan Stein

McMaster University

Chief Medical Officer since 2015

MD, PhD

Sam

McMaster University

Chief Executive Officer since 2023

MBA from McMaster University

Findings from Research

A consensus was reached among 22 European specialists on 43 out of 50 key areas regarding the use of sacral nerve stimulation (SNS) for treating fecal incontinence and constipation, indicating a strong agreement on best practices.

The findings from this modified Delphi process, which included a systematic review of 393 articles, provide a benchmark for safe and effective implementation of SNS/SNM in clinical settings across Europe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacral nerve stimulation for faecal incontinence and constipation: a European consensus statement. Maeda, Y., O'Connell, PR., Lehur, PA., et al.[2022]

In a study of 59 children and adolescents with chronic refractory constipation, noninvasive sacral neuromodulation (SNM) showed an impressive 86% overall responsiveness compared to only 39% in the conventional treatment group, highlighting its efficacy.

SNM treatment significantly improved defecation frequency, stool consistency, and reduced fecal incontinence episodes, while also enhancing quality of life scores, indicating it is a promising alternative to more invasive treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive Sacral Neuromodulation in Children and Adolescents: A Case-Control Study of Patients With Chronic Refractory Constipation. Diez, S., Kirchgatter, A., Adam, D., et al.[2023]

Sacral nerve modulation is an effective treatment for constipation that has not responded to conservative methods, showing significant improvement in Wexner constipation scores from a mean of 17.0 to 10.2 after the initial evaluation phase.

However, only 52% of patients continued with the treatment at the latest follow-up, indicating that while the therapy can be effective, its long-term sustainability may be a concern, particularly as younger patients were more likely to benefit from the initial evaluation phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medium-term outcome of sacral nerve modulation for constipation. Govaert, B., Maeda, Y., Alberga, J., et al.[2022]

Sacral neuromodulation (SNM) significantly improved constipation symptoms in all 7 patients studied, with defecation frequency increasing from 0.6 to 8.0 times per week and defecation time decreasing from 22.9 to 3.7 minutes after a median follow-up of 4 months.

SNM is a safe and minimally invasive treatment option for patients with intractable constipation, particularly those who have not responded to traditional treatments or surgeries, as evidenced by significant reductions in constipation scores and improvements in patient-reported outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Sacral neuromodulation in the treatment of intractable constipation]. Zheng, J., Li, S., Nie, Y., et al.[2018]

Sacral neuromodulation (SN) has shown promising efficacy in treating constipation, with over 50% of patients experiencing improvement during temporary neuromodulation and about 90% maintaining results after permanent implantation, based on a review of 10 studies involving 350 procedures.

While SN can be effective, it is associated with a high rate of adverse effects, primarily related to electrode positioning, highlighting the need for careful patient selection and further research to identify predictive factors for successful outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of sacral neuromodulation for management of constipation. Sharma, A., Bussen, D., Herold, A., et al.[2014]

In a study of 15 patients with slow-transit constipation (STC), sacral nerve modulation (SNM) led to significant improvements in constipation symptoms and quality of life, with a mean improvement of 10 points in the Wexner Constipation Score and 6.2 points in quality of life measures.

The treatment was safe, with no reported complications, and 60% of patients opted for permanent implantation after an initial 4-week trial, indicating its potential as a long-term solution for STC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of slow-transit constipation with sacral nerve modulation. Naldini, G., Martellucci, J., Moraldi, L., et al.[2010]

Sacral neuromodulation (SNM) with the InterStim II system has evolved into a minimally invasive procedure, significantly improving treatment success rates for chronic urinary and bowel dysfunction, with a response rate of approximately 80%.

Recent advancements, such as the tined lead and smaller neurostimulator, have enhanced patient comfort, reduced technical failures, and improved quality of life, making SNM a viable option for patients who do not respond to conservative treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Latest technologic and surgical developments in using InterStim Therapy for sacral neuromodulation: impact on treatment success and safety. Spinelli, M., Sievert, KD.[2008]

A systematic review of 17 studies on sacral neuromodulation (SNM) found that adjusting stimulation parameters, such as frequency and pulse width, can enhance treatment efficacy for urinary and bowel dysfunction, with some studies showing no risk of bias.

High-frequency stimulation and specific pulse widths, along with short cycling intervals, were particularly effective in improving outcomes and quality of life for patients, indicating potential for better management of these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stimulation Parameters for Sacral Neuromodulation on Lower Urinary Tract and Bowel Dysfunction-Related Clinical Outcome: A Systematic Review. Assmann, R., Douven, P., Kleijnen, J., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Sacral nerve stimulation for faecal incontinence and constipation: a European consensus statement. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Noninvasive Sacral Neuromodulation in Children and Adolescents: A Case-Control Study of Patients With Chronic Refractory Constipation. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Medium-term outcome of sacral nerve modulation for constipation. [2022]

4. China pubmed.ncbi.nlm.nih.gov

[Sacral neuromodulation in the treatment of intractable constipation]. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Review of sacral neuromodulation for management of constipation. [2014]

6. England pubmed.ncbi.nlm.nih.gov

Treatment of slow-transit constipation with sacral nerve modulation. [2010]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Latest technologic and surgical developments in using InterStim Therapy for sacral neuromodulation: impact on treatment success and safety. [2008]

8. Germany pubmed.ncbi.nlm.nih.gov

Retrospective study of sacral neuromodulator implantations in a French hospital center: Lifespan and hospital costs assessment. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Neuromodulation for constipation: sacral and transcutaneous stimulation. [2011]

10. United States pubmed.ncbi.nlm.nih.gov

Sacral Neuromodulation for Lower Urinary Tract and Bowel Dysfunction in Animal Models: A Systematic Review With Focus on Stimulation Parameter Selection. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Stimulation Parameters for Sacral Neuromodulation on Lower Urinary Tract and Bowel Dysfunction-Related Clinical Outcome: A Systematic Review. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Long-term outcome of intractable constipation treated by sacral neuromodulation: a comparison between children and adults. [2019]