Resistance Device for Bowel Incontinence

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Neurological disorders, Muscle diseases, Inflammatory bowel, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

340 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device designed to strengthen continence muscles, potentially improving symptoms for those with bowel incontinence. Researchers believe that working these muscles against resistance can strengthen them and reduce incontinence severity. The trial includes exercises with varying resistance levels using the Continence Muscles Resistance Device to assess improvements in muscle function. Individuals with weakened anal muscles who can perform these exercises may qualify for participation. As an unphased trial, this study allows participants to contribute to innovative research that could lead to new treatment options for bowel incontinence.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this resistance device is safe for bowel incontinence?

Research shows that devices similar to the Continence Muscles Resistance Device, used for urinary incontinence, are generally safe. Although specific safety data for the Resistance Device for Bowel Incontinence is not yet available, similar devices have proven safe and helpful.

A document summarizing safety and potential benefits indicates sufficient evidence supports the overall safety of these types of devices. Thus, even though the exact device in this study hasn't undergone safety testing, similar devices for other conditions have been well-tolerated by patients.

This information should reassure participants about the safety of using the Continence Muscles Resistance Device in the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to managing bowel incontinence using a resistance device to enhance continence muscle function. Unlike traditional treatments like dietary changes, medications, or surgery, this method focuses on strengthening the muscles directly involved in continence through resistance training. The device offers tailored resistance levels and employs techniques like anorectal and vaginal manometry to measure muscle performance accurately. By potentially improving muscle strength and function, this approach could offer a non-invasive and customizable solution for individuals with bowel incontinence.

What evidence suggests that this resistance device is effective for bowel incontinence?

Research has shown that pelvic floor rehabilitation, which includes exercises to strengthen muscles controlling bowel movements, can effectively treat fecal incontinence, with success rates between 50% and 80%. This trial tests the Continence Muscles Resistance Device, which enhances these exercises by adding resistance to prevent muscle fatigue and build strength, similar to how lifting weights strengthens other muscles. Reports indicate that this type of resistance training can improve control over bowel movements. Overall, early results suggest promise for improving continence through muscle strengthening. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with weak anal sphincters but no history of fecal incontinence. It's not for those with neurological disorders, muscle diseases, inflammatory bowel conditions, complete normal pressure in anal muscles, total loss of rectal sensation or contraction ability, under 18s, certain hip conditions or severe defecation issues.

Inclusion Criteria

I have never had issues controlling my bowel movements.

I am over 18 and have weak anal muscles but can participate in the study.

Exclusion Criteria

I have inflammatory bowel disease or celiac disease.

I do not have dementia or diseases related to brain blood vessels.

I have a muscle disease such as muscular dystrophy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform Kegel-like exercises with varying resistance levels using the c-RED device for 6 weeks

6 weeks

Weekly virtual or phone meetings for reinforcement

Follow-up

Participants are monitored for changes in fecal incontinence severity and quality of life

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Continence Muscles Resistance Device

Trial Overview The study tests a resistance device designed to strengthen continence muscles. The hypothesis is that resisted contractions will combat fatigue in these muscles and improve control over bowel movements in individuals with weakened anal sphincters.

How Is the Trial Designed?

Group I: fatigability of various striated continence muscles healthy adults Active Control 1 Intervention

Device: anorectal manometry/vaginal manometry (female) with and without applying c-RED Participants will do repetitive anal contraction and sustained contraction without device and with device in a random order. For contraction with the device, three different resistance level will be applied as described previously. For isometric contraction, the annal balloon of the device will be inflated to internal pressure of 500mmHg, which is noncompressible. Participants will repeat the repetitive contraction and sustained contraction.

Group II: contribution of continence muscles motor function enhancement in improving fecal incontinence Active Control 1 Intervention

Device: anorectal manometry/vaginal manometry (female) with c-RED Patients will then be assigned to one of the exercise protocols for 6 weeks. Protocol 1: 20 Kegel like repetitive short contractions against a progressively increased intra-vaginal resistance Protocol 2: 40 Kegel like repetitive short contractions against a progressively increased intra-vaginal resistance Protocol 3: 20 Kegel like repetitive short contractions against a progressively increased intra-anal resistance Protocol 4: 40 Kegel like repetitive short contractions against a progressively increased intra-anal resistance Protocol 5: 20 Kegel like repetitive short contractions without device Protocol 6: 40 Kegel like repetitive short contractions without device Protocol 7: 20 Kegel like repetitive short contractions against the non-compressible balloon as previously mentioned Protocol 8:40 Kegel like repetitive short contractions against the non-compressible balloon as previously mentioned

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

A biofeedback training program significantly reduced inappropriate pelvic floor muscle contractions in 15 subjects with chronic constipation, leading to a 69.9% decrease in the anismus index after an average of 3.1 weeks of treatment.

Patients experienced improved defecation frequency and ease, with lasting benefits observed for up to 6.2 months post-treatment, as shown by changes in anorectal angles during defecation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outlet obstruction constipation (anismus) managed by biofeedback. Kawimbe, BM., Papachrysostomou, M., Binnie, NR., et al.[2019]

A comprehensive analysis of 7,766,737 adverse event records from the FDA's MAUDE database revealed that 96.6% of reports came from manufacturers, highlighting a significant reliance on manufacturers for safety data.

Patient and nurse reports to the FDA were much more common than physician reports, with only 0.49% of physician reports submitted directly, indicating a need for improved physician engagement in reporting adverse events to enhance post-market surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporter's occupation and source of adverse device event reports contained in the FDA's MAUDE database. Kavanagh, KT., Brown, RE., Kraman, SS., et al.[2022]

A significant portion of medical device adverse event reports submitted to the FDA's MAUDE database (approximately 47.9%) were classified as categories other than death, despite containing terms indicating that a patient had died.

The study found that about 23% of reports involving patient deaths were misclassified, suggesting that around 31,552 reports may have inaccurately categorized deaths, highlighting a critical need for improved accuracy in adverse event reporting to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of Death in US Food and Drug Administration Medical Device Adverse Event Reports in Categories Other Than Death. Lalani, C., Kunwar, EM., Kinard, M., et al.[2022]

A review of 42 medical device reports on vaginal energy-based devices revealed that most patient complaints, including vaginal pain and urinary symptoms, were not severe, with serious adverse events being rare (only 3.5% reported third-degree burns).

The majority of complaints were reported after the FDA's July 30, 2018 warning, suggesting that increased awareness and potential litigation may have influenced reporting rates, highlighting the need for further research on the safety and efficacy of these devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaginal energy-based devices: characterization of adverse events based on the last decade of MAUDE safety reports. Wallace, SL., Sokol, ER., Enemchukwu, EA.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4174224/

Pelvic Floor Rehabilitation in the Treatment of Fecal ... Pelvic floor rehabilitation treatment for FI is thought to be effective and safe, with reported success rates in a majority of studies at 50 to 80%. Many more ...

2. withpower.com withpower.com/trial/phase-fecal-incontinence-9-2024-c5f76

Resistance Device for Bowel Incontinence Trial Overview The study tests a resistance device designed to strengthen continence muscles. The hypothesis is that resisted contractions will combat fatigue ...

3. mdpi.com mdpi.com/2624-5647/6/3/53

Effectiveness of Pelvic Floor Muscle Training for Treating ... The effectiveness of pelvic floor muscle training for treating faecal incontinence ranges from 41% to 66%, and there are reports that this rate ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2772973723009219

Clinical assessment, conservative management ... ... muscles are contracted, held, and relaxed with the aim of improving muscle strength, tone, endurance, and coordination to increase control over fecal leakage.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3096428/

New Options for the Treatment of Fecal Incontinence - PMC At a median follow-up of 19 months all patients showed continued improvement in continence and in resting and squeeze pressures. As with other new technologies, ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf13/H130006b.pdf

Summary of Safety and Probable Benefit (SSPB) Based on the overall safety and probable benefit data, the device has demonstrated sufficient evidence to support the conclusion of overall safety and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10867159/

Faecal incontinence—a comprehensive review - PMC By creating passive resistance, the device contributes to controlling faecal continence (65). While initial feasibility studies showed promise, due to high ...

8. gastrojournal.org gastrojournal.org/article/S0016-5085(99)70176-9/fulltext

Safety and efficacy of dynamic muscle plasty for anal ... Conclusions: Dynamic graciloplasty may be an effective procedure for patients with refractory, end-stage fecal incontinence as well as for patients who require ...

9. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/fecal-incontinence

Fecal Incontinence Clinical Trials The purpose of this study is to to evaluate the safety and effectiveness of the Eclipse System for the treatment of Fecal Incontinence (FI) in adult women.