Defecation Posture Device for Rectocele

Recruiting at 2 trial locations

Overseen By Meredith Carrel-Lammert

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: TriHealth Inc.

Must not be taking: Opiates

Disqualifiers: Bowel disease, Wheelchair bound, 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: 1

Duration: 2 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The study aims to determine if defecation posture, when using a defecation posture modification device (DPMD), will improve ease of bowel movements in patients with pelvic organ prolapse, specifically rectoceles.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Defecation Posture Modification Device for Rectocele?

Research suggests that defecation posture-modifying devices (DPMDs) can help improve bowel movement patterns by mimicking the benefits of squatting, which may aid in stool evacuation by straightening the anorectal angle and relaxing the pelvic floor. While specific studies on rectocele are not mentioned, these devices have shown potential benefits in improving constipation symptoms in other contexts. ^{1 2 3 4 5}

Is the Defecation Posture Device safe for humans?

The studies reviewed do not report any safety concerns for defecation posture devices, suggesting they are generally safe for use in humans. ^{1 2 4 6 7}

How is the Defecation Posture Modification Device unique compared to other treatments for rectocele?

The Defecation Posture Modification Device, like the Squatty Potty, is unique because it helps people achieve a squatting position during bowel movements, which can straighten the anorectal angle and relax the pelvic floor, potentially improving symptoms of rectocele. This approach is different from other treatments as it focuses on changing the posture during defecation rather than using medications or surgical interventions. ^{1 2 3 4 7}

Eligibility Criteria

This trial is for individuals with pelvic organ prolapse, including a rectocele at Stage 2 or greater, who experience bowel dysfunction. Participants must not be wheelchair-bound, over 250 lbs, using opiates daily, pregnant, planning surgery soon, or have certain bowel diseases like Crohn's.

Inclusion Criteria

I have a pelvic organ prolapse affecting my bowel functions.

Exclusion Criteria

Inability to understand English

Daily opiate use

Anyone currently using a defecation posture modification device

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a defecation posture modification device (DPMD) to improve ease of bowel movements

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Defecation Posture Modification Device

Trial Overview The study tests whether a Defecation Posture Modification Device (DPMD) can make it easier for patients with rectoceles to have bowel movements. It explores the impact of changing how one sits during defecation on easing these movements.

Participant Groups

Group I: Defecation Posture Modification Device Experimental Treatment 1 Intervention

Patients will be given a Squatty Potty Device

Defecation Posture Modification Device is already approved in United States, European Union for the following indications:

Approved in United States as Squatty Potty for:

• Constipation relief
• Hemorrhoid prevention
• Improved bowel evacuation

Approved in European Union as Defecation Posture Modification Device for:

• Constipation relief
• Improved bowel evacuation

Who Is Running the Clinical Trial?

TriHealth Inc.

Lead Sponsor

Trials

103

Recruited

54,100+

Findings from Research

Defecation posture-modifying devices (DPMDs) may help improve constipation symptoms by mimicking the benefits of squatting, which can enhance stool evacuation by straightening the anorectal angle and relaxing the pelvic floor.

The effectiveness of DPMDs in normalizing anorectal function in adults with chronic constipation has not yet been studied, indicating a gap in research that could inform future treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can a Defecation Posture Modifying Device Correct an Abnormal Balloon Expulsion Test in Chronically Constipated Patients? Koo, E., Chey, WD., Ezell, G., et al.[2023]

The use of defecation postural modification devices (DPMDs) significantly improved bowel emptying, with participants experiencing 3.64 times higher odds of feeling completely empty after using the device.

Participants also reported reduced straining during bowel movements when using DPMDs, with odds of straining decreasing to 0.23, and overall bowel movement duration was shorter with the device, indicating a positive impact on bowel health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a Defecation Posture Modification Device: Impact on Bowel Movement Patterns in Healthy Subjects. Modi, RM., Hinton, A., Pinkhas, D., et al.[2020]

A systematic review of 10 studies found that devices like pessaries and a vaginal stent can significantly improve symptoms of obstructive defecation syndrome (ODS) in patients with posterior pelvic organ prolapse (POP).

Meta-analysis showed that the use of pessaries led to significant improvements in stool evacuation and overall distress related to defecation, although the studies varied widely in methodology and reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posterior compartment prolapse and perineal descent: systematic review of available support devices. Van den Broeck, S., Nullens, S., Jacquemyn, Y., et al.[2023]

In a study of 12 healthy subjects, the side lying position resulted in significantly longer expulsion times for defecation compared to seated and squatting positions, indicating that lying down may hinder effective bowel movements.

Both seated and squatting positions showed similar maximum evacuation pressures and anal squeeze pressures, suggesting that these positions are more effective for defecation than lying down.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecobionics assessment of the effect of position on defecatory efficacy in normal subjects. Chen, SC., Futaba, K., Leung, WW., et al.[2022]

Sacral neuromodulation (SNM) has been shown to be a safe and effective treatment for defecation disorders that arise or worsen after pelvic or colorectal surgery, with 73.3% of patients benefiting enough to receive a permanent device.

In a study of 37 patients, those treated with SNM experienced a significant reduction in constipation symptoms, as indicated by the Cleveland Clinic Constipation Score, from an average of 17.5 preoperatively to 10.4 after one year, demonstrating the long-term efficacy of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacral Neuromodulation for defecation disorders after non oncologic pelvic surgery. Martellucci, J., Annicchiarico, A., Scheiterle, M., et al.[2023]

In a study of 60 healthy individuals, different seating conditions (mat, block, and a 10º inclined wedge) significantly affected spinal and pelvic angles, with the inclined wedge showing a greater impact on lumbar flexion compared to the block.

Gender differences were observed, with males exhibiting more lumbar flexion and pelvic tilt than females, suggesting that personalized seating aids could be designed based on these differences in posture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can different seating aids influence a sitting posture in healthy individuals and does gender matter? Sheeran, L., Hemming, R., van Deursen, R., et al.[2020]

Constipation significantly affects the quality of life and health costs for the elderly, potentially leading to serious gastrointestinal issues like colon cancer and hemorrhoids.

The review highlights the need for assistive devices that help older adults achieve a semi-squatting posture for defecation, addressing the challenges posed by musculoskeletal issues and lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review on squat-assist devices to aid elderly with lower limb difficulties in toileting to tackle constipation. Hari Krishnan, R.[2019]

References

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

Can a Defecation Posture Modifying Device Correct an Abnormal Balloon Expulsion Test in Chronically Constipated Patients? [2023]

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

Implementation of a Defecation Posture Modification Device: Impact on Bowel Movement Patterns in Healthy Subjects. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Posterior compartment prolapse and perineal descent: systematic review of available support devices. [2023]

4. Italy pubmed.ncbi.nlm.nih.gov

Fecobionics assessment of the effect of position on defecatory efficacy in normal subjects. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Sacral Neuromodulation for defecation disorders after non oncologic pelvic surgery. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Can different seating aids influence a sitting posture in healthy individuals and does gender matter? [2020]

7. England pubmed.ncbi.nlm.nih.gov

A review on squat-assist devices to aid elderly with lower limb difficulties in toileting to tackle constipation. [2019]