Electrical Rectal Stimulation for Neurogenic Bowel Dysfunction

Recruiting at 1 trial location

Overseen By Cesar Colasante-Garrido, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Sepsis, Pressure sores, Crohn's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help individuals with spinal cord injuries manage constipation. It compares traditional finger stretching of the rectum with electrical rectal stimulation to determine which method moves stool through the colon more effectively. The researchers aim to discover if electrical stimulation can serve as a better alternative for improving bowel function. The trial seeks participants with neurogenic bowel dysfunction who currently use digital rectal stimulation for management. Participants will try both methods and provide feedback on their experiences. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance bowel dysfunction management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that electrical rectal stimulation is safe for improving colonic motility?

Research has shown that electrical stimulation might help treat bowel problems caused by nerve issues, especially after a spinal cord injury. A review of clinical studies found that this method can improve bowel function. Past studies used electrical stimulation to create strong but manageable muscle movements. Patients reported a better quality of life and fewer bladder infections, common problems linked to bowel issues.

While these studies suggest the treatment is generally well-tolerated, individual experiences can differ. No major reports of serious side effects have emerged, making this method a possible option to consider with a doctor's guidance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about electrical rectal stimulation for neurogenic bowel dysfunction because it offers a novel approach compared to current methods like manual digital stimulation. Unlike traditional techniques that rely on physical manipulation, electrical rectal stimulation uses electrical impulses to stimulate bowel movements, potentially improving efficiency and reducing the need for manual intervention. This method could lead to more consistent results and greater independence for patients. Additionally, it may enhance patient comfort and reduce caregiver burden, making it a promising alternative for managing neurogenic bowel dysfunction.

What evidence suggests that electrical rectal stimulation is effective for neurogenic bowel dysfunction?

Research has shown that electrical stimulation in the rectum can help manage bowel problems in individuals with nerve-related bowel issues. A review of studies found that this method improves bowel function in patients with spinal cord injuries. In this trial, participants will first provide data using their usual digital rectal stimulation intervention for bowel care, then provide data using electrical stimulation for bowel care. Another study noted that electrical rectal stimulation could serve as a helpful alternative to manual methods, such as using a finger, for emptying the bowels. These findings suggest that electrical stimulation may enhance colon movement and relieve constipation. Early evidence supports its potential as a treatment for managing bowel issues. ^{1 3 4 5 6}

Who Is on the Research Team?

Cesar Colasante-Garrido, MD

Principal Investigator

Syracuse VA Medical Center, Syracuse, NY

Dennis Bourbeau, PhD

Principal Investigator

Louis Stokes VA Medical Center, Cleveland, OH

Are You a Good Fit for This Trial?

This trial is for adults over 18 with stable spinal cord injuries above the sacral region, diagnosed with neurogenic bowel dysfunction, and who have been using digital rectal stimulation for at least a year. It's not suitable for those with active infections, open sores near the pelvis, recent gut surgery or significant colon issues.

Inclusion Criteria

I need significant help to have a bowel movement.

It has been over a year since my neurological diagnosis.

My neurological condition is stable.

Exclusion Criteria

I am currently suffering from a severe infection.

I have open sores near my pelvis.

I have had major injury to my colon or have a colostomy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will first use their usual digital rectal stimulation intervention, followed by electrical stimulation for bowel care

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Electrical Rectal Stimulation

Trial Overview The study tests if electrical stimulation of the rectum can improve bowel movement in people with spinal cord injuries better than manual stretching. Participants will be compared to see which method more effectively aids in emptying their bowels.

How Is the Trial Designed?

Group I: Bowel emptying Experimental Treatment 1 Intervention

Study participants will act as their own controls, first providing data using their usual digital rectal stimulation intervention for bowel care, then providing data using electrical stimulation for bowel care.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Electric stimulation of bowel motor activity significantly accelerates the rehabilitation of bowel function after surgery, based on 208 stimulations performed in the study.

While it does not prevent severe functional intestinal obstruction, electric stimulation is an effective treatment method for managing such obstructions and should be routinely used in intensive postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Electric stimulation of intestinal motility in the postoperative period]. Nechaĭ, AI., Ostrovskaia, MS., Gudkov, GV., et al.[2007]

Functional electrical stimulation of the anal mucosa can help differentiate between supraspinal and segmental detrusor hyperreflexia, which is important for diagnosing bladder control issues.

This method enhances our understanding of how micturition works and aids in selecting the right treatment for patients based on their specific condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional electrical stimulation: method to differentiate supraspinal from segmental detrusor hyperreflexia. Vignoli, GC., Martelli, A.[2019]

An electrical stimulator designed to treat neurogenic faecal incontinence effectively increased anal canal pressure and external anal sphincter activity in a study of eight patients over two months.

After treatment, seven out of eight patients achieved continence, demonstrating the efficacy of this stimulation method in improving control over bowel movements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the pudendo-anal reflex in the treatment of neurogenic faecal incontinence. Binnie, NR., Kawimbe, BM., Papachrysostomou, M., et al.[2019]

In a study of 45 children with primary monosymptomatic enuresis, those receiving parasacral transcutaneous electrical neural stimulation along with behavioral therapy showed a significantly greater improvement in the number of dry nights (61.8%) compared to those receiving only behavioral therapy (37.3%).

While the treatment was effective, no participants achieved complete resolution of their enuresis symptoms, indicating that while the method is beneficial, it may not fully eliminate the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous parasacral electrical neural stimulation in children with primary monosymptomatic enuresis: a prospective randomized clinical trial. de Oliveira, LF., de Oliveira, DM., da Silva de Paula, LI., et al.[2013]

In a pilot study involving 10 children with treatment-resistant constipation, transcutaneous electrical stimulation (TES) significantly increased bowel movements from an average of 0.9 to 4.1 per week after 3 months, with 6 out of 9 children achieving at least 3 bowel movements per week.

TES also reduced the frequency of soiling episodes from an average of 5.9 to 1.9 days per week, and many children were able to reduce or stop their laxative use, leading to improved quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home Transcutaneous Electrical Stimulation Therapy to Treat Children With Anorectal Retention: A Pilot Study. Yik, YI., Stathopoulos, L., Hutson, JM., et al.[2022]

Daily transcutaneous electrical stimulation (TES) at home significantly improved bowel function in children with slow-transit constipation, increasing the average number of defecations per week from 2.5 to 6.7 episodes.

The treatment was safe, with no adverse events reported, and it may provide a novel, convenient alternative to hospital visits for managing intractable constipation in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily transabdominal electrical stimulation at home increased defecation in children with slow-transit constipation: a pilot study. Ismail, KA., Chase, J., Gibb, S., et al.[2009]

In a study involving 11 patients with intact nervous systems, electrical stimulation of the rectal ampulla successfully triggered the desire to void and defecate, indicating its potential efficacy in managing lower urinary and fecal incontinence.

The stimulation caused contractions in the detrusor muscle and rectal ampulla while relaxing the anal sphincter, suggesting a mechanism of action that could be beneficial for patients struggling with emptying their lower urinary tract or fecal system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical stimulation of the rectal ampulla causing reflex voiding. Godec, C., Ayala, G., Cass, A.[2019]

In a study of 17 patients with anorectal conditions, external neuromyogenic electrostimulation (ENS) significantly improved continence scores and quality of life after 6 weeks of home treatment, indicating its efficacy for managing anorectal continence problems.

Patients showed increased maximum voluntary squeeze pressures from 56.1 to 100.7 cmH2O, suggesting that ENS effectively enhances anal muscle function, which is crucial for continence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of external neuromyogenic stimulation on neuromuscular anorectal incontinence. Ergun, O., Tatlisu, R., Pehlivan, M., et al.[2019]

In a study of 40 children aged 5-17 with Bladder and Bowel Dysfunction (BBD), an enlarged rectal diameter (RD) of over 3 cm was found to be a strong predictor of persistent functional constipation after treatment, with an odds ratio of 9.56.

The study demonstrated that 73.3% of children with an enlarged RD continued to experience functional constipation post-treatment, highlighting the importance of measuring RD as both a diagnostic and prognostic tool in managing BBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between rectal diameter and response to treatment with parasacral transcutaneous electrical nerve stimulation and behavioral changes in children and adolescents with bladder and bowel dysfunction. Nunes, NC., de Abreu, GE., Dourado, ER., et al.[2023]

Electrical stimulation of the distal colon successfully evoked colonic activity in all eight neural-intact cats studied, indicating its potential as a method to enhance bowel function.

The study suggests that the effectiveness of colonic stimulation is influenced by the location of stimulation and the type of anesthesia used, highlighting the need for further research to optimize this approach for improving colonic motility in individuals with neurogenic bowel dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical Colon Stimulation Reflexively Increases Colonic Activity. Bourbeau, D., Aamoth, K., Brose, S., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8818104/

Evaluation the Efficiency of Electrical Stimulation Advanced ... Electrical stimulation includes magnetic stimulation use of sacral nerve or deep muscles which has been used to improve the social performance of bowel and ...

2. journals.lww.com journals.lww.com/md-journal/fulltext/2018/10120/a_systematic_review_of_clinical_studies_on.78.aspx

A systematic review of clinical studies on electrical... A systematic review of clinical studies on electrical stimulation therapy for patients with neurogenic bowel dysfunction after spinal cord injury.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10653754/

Minimally invasive electrical rectal stimulation promotes ... This study presents a description of using electrical rectal stimulation as an alternative to DRS to help manage bowel emptying in a person with SCI.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1521691810001642

15 Neuromodulation for constipation: Sacral and ... This paper reviews methods of neuromodulation used to treat constipation. This includes direct stimulation of sacral nerves and stimulation across the skin.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/codi.70276

The effect of neuromuscular electrical stimulation on bowel ... Stimulation intensity was set to elicit strong but tolerable contractions. Five visits over 24 weeks assessed bowel and bladder function ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3618949/

Neurostimulation for Neurogenic Bowel Dysfunction - PMC SNS can reduce NBD in selected patients with a variety of incomplete neurological lesions. Peripheral stimulation using electrical stimulation ...