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

Trial Summary

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 data supports the effectiveness of this treatment for neurogenic bowel dysfunction?

Research shows that transcutaneous electrical stimulation (TES) can increase bowel movements in children with constipation and improve symptoms in those with bladder and bowel dysfunction. Additionally, electric stimulation has been effective in enhancing bowel function after surgery, suggesting potential benefits for neurogenic bowel dysfunction. ^{1 2 3 4 5}

How does electrical rectal stimulation differ from other treatments for neurogenic bowel dysfunction?

Electrical rectal stimulation is unique because it uses electrical impulses to stimulate the rectum, which can help trigger bowel movements by mimicking natural reflexes. This approach is different from traditional methods like mechanical rectal distension, as it directly targets the nervous system to improve bowel function. ^{6 7 8 9 10}

What is the purpose of this trial?

The investigators are testing the effect of electrical stimulation of the rectum on colonic motility. Most individuals with spinal cord injury develop neurogenic bowel dysfunction, which includes slowed colonic motility, which means that stools take longer than normal to pass through the colon. This slowed movement may result in chronic constipation and difficulty emptying the bowels. Individuals typically (without or without caregiver assistance) insert a gloved finger into the rectum and gently stretch it to improve colonic motility for a brief period to empty the bowels. The investigators hypothesize that electrically stimulating the rectum, instead of mechanically stretching it, will produce the same beneficial effect of improving colonic motility. Therefore, this study will compare the two methods. If electrical stimulation effectively improves colonic motility, then the investigator shall develop the approach as a therapeutic intervention in future studies.

Research Team

Dennis Bourbeau, PhD

Principal Investigator

Louis Stokes VA Medical Center, Cleveland, OH

Cesar Colasante-Garrido, MD

Principal Investigator

Syracuse VA Medical Center, Syracuse, NY

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Electric stimulation of intestinal motility in the postoperative period]. [2007]

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

Home Transcutaneous Electrical Stimulation Therapy to Treat Children With Anorectal Retention: A Pilot Study. [2022]

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

Transcutaneous parasacral electrical neural stimulation in children with primary monosymptomatic enuresis: a prospective randomized clinical trial. [2013]

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

Daily transabdominal electrical stimulation at home increased defecation in children with slow-transit constipation: a pilot study. [2009]

5. Brazil 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. [2023]

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

The efficacy of external neuromyogenic stimulation on neuromuscular anorectal incontinence. [2019]

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

Functional electrical stimulation: method to differentiate supraspinal from segmental detrusor hyperreflexia. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Use of the pudendo-anal reflex in the treatment of neurogenic faecal incontinence. [2019]

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

Electrical Colon Stimulation Reflexively Increases Colonic Activity. [2022]

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

Electrical stimulation of the rectal ampulla causing reflex voiding. [2019]