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.
Is Sacral Neuromodulation a promising treatment for chronic constipation?Yes, Sacral Neuromodulation is a promising treatment for chronic constipation. It has been effective in treating bowel dysfunction and constipation in both adults and children. It is a minimally invasive therapy that has shown success rates between 50% and 80%, and ongoing research aims to improve these outcomes further.6891011
What data supports the idea that Low Level Laser Therapy for Chronic Constipation is an effective treatment?The available research shows that sacral neuromodulation, a treatment for chronic constipation, has been effective in various studies. For example, one study found that it successfully helped adults with severe constipation who did not respond to other treatments. Another study highlighted its potential for children and teenagers, suggesting it could be a less invasive option with similar benefits. Overall, these studies indicate that sacral neuromodulation can be a promising treatment for those struggling with chronic constipation.456711
Do I have to stop taking my current medications?The trial requires that you stop taking NSAIDs or steroids.
What safety data is available for Low Level Laser Therapy for Chronic Constipation?The safety data for sacral neuromodulation (SNM), which is related to Low Level Laser Therapy for Chronic Constipation, indicates that it is generally considered safe. Adverse events reported include electrode migration and infection. The therapy involves implanting a device to modulate neural activity, and a testing phase is available to predict treatment outcomes. However, the level of evidence is low, and further studies are needed to fully assess safety and efficacy.123512
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.
I take NSAIDs or steroids.
I currently have a deep vein thrombosis.
Treatment Details
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.
1Treatment groups
Experimental Treatment
Group I: Refractory Constipation with LLLTExperimental Treatment1 Intervention
Low level laser therapy (LLLT) will be administered to patients with severe refractory chronic constipation
Sacral Neuromodulation is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as InterStim for:
- Overactive bladder
- Urinary urgency
- Frequency
- Urge incontinence
- Nonobstructive urinary retention
- Chronic fecal incontinence
🇪🇺 Approved in European Union as InterStim for:
- Overactive bladder
- Urinary urgency
- Frequency
- Urge incontinence
- Nonobstructive urinary retention
- Chronic fecal incontinence
- Chronic constipation
🇨🇦 Approved in Canada as InterStim for:
- Overactive bladder
- Urinary urgency
- Frequency
- Urge incontinence
- Nonobstructive urinary retention
- Chronic fecal incontinence
- Chronic constipation
Find a clinic near you
Research locations nearbySelect from list below to view details:
McMaster UniversityHamilton, Canada
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Who is running the clinical trial?
McMaster UniversityLead Sponsor
References
Latest technologic and surgical developments in using InterStim Therapy for sacral neuromodulation: impact on treatment success and safety. [2008]This article accompanies a "surgery in motion" DVD on sacral neuromodulation (SNM) with InterStim Therapy, which visualizes the implantation of the InterStim II system. The article describes the technical and surgical developments of SNM and their impact on treatment success, safety, and patient's quality of life (QoL).
Treatment of slow-transit constipation with sacral nerve modulation. [2010]Constipation is common and a selection of the best treatment is difficult, especially for slow-transit constipation (STC). The aim of the study was to assess the effect of sacral nerve modulation (SNM) on STC.
Neuromodulation for constipation: sacral and transcutaneous stimulation. [2011]Constipation is a frequently occurring digestive ailment that is usually treated conservatively. Neuromodulation is altering function of an organ by altering neural activity. This paper reviews methods of neuromodulation used to treat constipation. This includes direct stimulation of sacral nerves and stimulation across the skin. Direct stimulation of sacral nerves is the most well developed method and is presented in detail. It is generally accepted that the mechanism of action is modulation rather than stimulation so it is called sacral neuromodulation (SNM). SNM involves percutaneous placement of an electrode in the third sacral foramen and implanting a stimulating device under the skin in the buttocks. SNM is founded on the physiological principle that activity in one neural pathway modulates pre-existing activity in another through synaptic interaction. The mechanism of action in constipation may be neuromodulation of the extrinsic neural control of the large bowel or modulation of reflexes inhibiting large bowel function. Limited evidence is available to assess the outcome of SNM in constipation. Results in the medium term seem promising for selected patients with idiopathic slow and normal transit constipation not responding to optimal conservative treatment. Adverse events include electrode migration and infection. The availability of a testing phase provides a predictor of treatment outcome. In addition, transcutaneous stimulation using sticky pad electrodes over the lumbosacral region or acupuncture points has been reported to improve constipation symptoms. In general, the level of evidence is low and further studies are needed.
Medium-term outcome of sacral nerve modulation for constipation. [2022]Sacral nerve modulation has been reported as a minimally invasive and effective treatment for constipation refractory to conservative treatment.
Review of sacral neuromodulation for management of constipation. [2014]Sacral neuromodulation (SN) is an emerging treatment for constipation. This review evaluates the mechanism of action, techniques, efficacy, and adverse effects of SN in the management of constipation.
[Sacral neuromodulation in the treatment of intractable constipation]. [2018]To assess the efficacy of sacral neuromodulation (SNM) in patients with intractable constipation.
Sacral nerve stimulation for faecal incontinence and constipation: a European consensus statement. [2022]In Europe during the last decade sacral nerve stimulation (SNS) or sacral neuromodulation (SNM) has been used to treat faecal incontinence (FI) and constipation. Despite this, there is little consensus on baseline investigations, patient selection and operative technique. A modified Delphi process was conducted to seek consensus on the current practice of SNS/SNM for FI and constipation.
Long-term outcome of intractable constipation treated by sacral neuromodulation: a comparison between children and adults. [2019]Sacral neuromodulation (SNM) is a minimally invasive therapy for functional constipation (FC) and is most often used to treat adults. Recent studies suggest that SNM may also beneficial in children. However, comparative data regarding preferred age of SNM for FC are lacking. Therefore, long-term results of SNM for FC were compared between children and adults.
Sacral Neuromodulation for Lower Urinary Tract and Bowel Dysfunction in Animal Models: A Systematic Review With Focus on Stimulation Parameter Selection. [2022]Conventional sacral neuromodulation (SNM) has shown to be an effective treatment for lower urinary tract and bowel dysfunction, but improvements of clinical outcome are still feasible. Currently, in preclinical research, new stimulation parameters are being investigated to achieve better and longer effects. This systematic review summarizes the status of SNM stimulation parameters and its effect on urinary tract and bowel dysfunction in preclinical research.
Stimulation Parameters for Sacral Neuromodulation on Lower Urinary Tract and Bowel Dysfunction-Related Clinical Outcome: A Systematic Review. [2022]Sacral neuromodulation (SNM) has been used to treat patients with lower urinary tract dysfunction and bowel dysfunction for many years. Success rates vary between 50% and 80%, indicating that there is much room for improvement. Altering stimulation parameters may result in improved outcome. This paper reports a systematic review of the clinical efficacy of nonconventional stimulation parameters on urinary tract and bowel dysfunction.
Noninvasive Sacral Neuromodulation in Children and Adolescents: A Case-Control Study of Patients With Chronic Refractory Constipation. [2023]In adult patients with chronic refractory constipation, invasive sacral neuromodulation (SNM) has been applied successfully. There is a need for less invasive solutions while providing comparable therapeutic effects in children and adolescents. We present a prospective, interventional case-control study on the application of noninvasive SNM.
Retrospective study of sacral neuromodulator implantations in a French hospital center: Lifespan and hospital costs assessment. [2023]Sacral nerve neuromodulation (SNM) is a safe and effective therapy for the management of fecal and/or urinary incontinence. The generators InterStim™ and InterStim™ II (Medtronic™) are non-rechargeable active implantable medical devices with a limited lifespan. The aims of this study were to assess the generators' median lifespan for all indications and the long-term hospital costs of the therapy.