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

Trial Summary

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 data supports the effectiveness of the treatment Continence Muscles Resistance Device for bowel incontinence?

Research shows that resistance exercise can have positive effects on muscle strength and rehabilitation, which may suggest potential benefits for strengthening continence muscles. A prototype rehabilitation device with variable resistance has been shown to aid in muscle strength training, which could be relevant for improving muscle control in bowel incontinence. ^{1 2 3 4 5}

Is the Resistance Device for Bowel Incontinence safe for humans?

There is no specific safety data available for the Resistance Device for Bowel Incontinence, but similar devices for urinary incontinence have been studied for safety. The Adjustable Continence Therapy device, used for urinary incontinence, has been evaluated for safety, suggesting that similar devices may be generally safe for human use. ^{6 7 8 9 10}

How does the Continence Muscles Resistance Device treatment differ from other treatments for bowel incontinence?

The Continence Muscles Resistance Device is unique because it likely involves a physical device to strengthen continence muscles, unlike biofeedback treatments that focus on training muscle control through visual feedback. This approach may offer a novel way to improve muscle strength directly, potentially providing an alternative for those who do not respond well to biofeedback. ^{11 12 13 14 15}

What is the purpose of this trial?

The investigators hypothesize that different continence muscles have different fatigue characteristics and fatigue induced by resisted contractions will result in significant increase in contractility of the continence muscles and improvement of fecal incontinence severity.

Eligibility Criteria

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

I have a muscle disease such as muscular dystrophy.

I have inflammatory bowel disease or celiac disease.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Muscle activation and strength in squat and Bulgarian squat on stable and unstable surface. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The influence of variable resistance moment arm on knee extensor performance. [2010]

3. Sweden pubmed.ncbi.nlm.nih.gov

Enhancing the examiner's resisting force improves the reliability of manual muscle strength measurements: comparison of a new device with hand-held dynamometry. [2014]

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

Electromyographic activity and applied load during seated quadriceps exercises. [2019]

5. England pubmed.ncbi.nlm.nih.gov

A prototype rehabilitation device with variable resistance and joint motion control. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

Treatment of moderate to severe female stress urinary incontinence with the adjustable continence therapy (ACT) device after failed surgical repair. [2021]

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

Vaginal energy-based devices: characterization of adverse events based on the last decade of MAUDE safety reports. [2021]

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

Reporting of Death in US Food and Drug Administration Medical Device Adverse Event Reports in Categories Other Than Death. [2022]

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

Real-World Complications of the SpaceOAR Hydrogel Spacer: A Review of the Manufacturer and User Facility Device Experience Database. [2023]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Reporter's occupation and source of adverse device event reports contained in the FDA's MAUDE database. [2022]

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

Management of anal incontinence by biofeedback. [2019]

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

Biofeedback in the management of partial anal incontinence. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Outlet obstruction constipation (anismus) managed by biofeedback. [2019]

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

An external device for faecal incontinence. [2014]

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

Biofeedback conditioning for fecal incontinence. [2019]