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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special device that might assist people with rectoceles (a type of pelvic organ prolapse) in having easier bowel movements. The goal is to determine if altering sitting posture during bathroom use can make a difference. Participants will use a device similar to a Squatty Potty, called a Defecation Posture Modification Device (DPMD), to assess its effectiveness for their condition. The trial seeks individuals with a rectocele who experience bowel issues but do not already use a similar device. As an unphased trial, it offers a unique opportunity to explore a non-invasive solution for improving bowel health.

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 prior data suggests that this defecation posture modification device is safe for use?

Research shows that using a Defecation Posture Modification Device (DPMD) is generally safe for most people. Studies have found that DPMDs make bowel movements easier by helping the body align better during the process. They reduce the time and effort needed and help people feel like they have emptied their bowels more completely.

Most of these studies involved healthy individuals, and no serious side effects were reported, indicating that the device is well-tolerated. The trial is labeled as "Not Applicable" for phase, meaning it does not focus on a new drug or treatment with unknown safety. Instead, it tests a device that changes posture, considered low-risk based on existing research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for rectocele, which often involve surgical interventions or pelvic floor exercises, the Defecation Posture Modification Device offers a non-invasive and straightforward approach. Researchers are excited about this trial because the device, similar to a Squatty Potty, adjusts the body's posture during defecation to potentially alleviate symptoms associated with rectocele. This method is unique in its simplicity and accessibility, providing a low-cost, at-home option that could improve bowel movements by optimizing the natural alignment of the rectum. This trial could reveal a practical and immediate solution for individuals seeking relief from discomfort without the need for surgery or complex therapies.

What evidence suggests that this defecation posture device is effective for improving bowel movements in patients with rectoceles?

Research shows that using a Defecation Posture Modification Device (DPMD) can ease bowel movements. Studies have found that these devices reduce bathroom time by over a minute and decrease the need to strain. Participants also reported feeling more completely emptied after using the device. This trial will evaluate the DPMD's effectiveness for individuals with rectoceles, a type of pelvic organ prolapse, by facilitating stool passage. Those experiencing difficulty with bowel movements due to a rectocele might benefit from participating in this trial. ^{1 2 3 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6382038/

Implementation of a Defecation Posture Modification Device Our results indicate that DPMDs positively influenced defecatory time, straining, and complete evacuation of bowels in a presumed healthy population.

2. journals.lww.com journals.lww.com/ajg/fulltext/2017/10001/implementation_of_a_defecation_posture.108.aspx

Implementation of a Defecation Posture Modification Device Our findings show reduced duration (4.24 vs. 5.60 min, P<0.001), reduced straining patterns (2.46 vs. 3.10, P<0.001), and increased bowel emptiness (2.19 vs.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06252714/impact-of-defecation-posture-on-ease-of-bowel-movements-in-patients-with-a-rectocele?state=OH&city=Montgomery

Impact of Defecation Posture on Ease of Bowel Movements ... ... posture modification device (DPMD), will improve ease of bowel movements in patients with pelvic organ prolapse, specifically rectoceles.

4. researchgate.net researchgate.net/publication/328441398_Implementation_of_a_Defecation_Posture_Modification_Device_Impact_on_Bowel_Movement_Patterns_in_Healthy_Subjects

Implementation of a Defecation Posture Modification Device A total of 1119 BMs were recorded (735 without DPMD and 384 with DPMD). Utilizing the DPMD resulted in increased bowel emptiness (odds ratio, 3.64; 95% ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30346317/

Impact on Bowel Movement Patterns in Healthy Subjects DPMDs positively influenced BM duration, straining patterns, and complete evacuation of bowels in this study.

6. pdfs.semanticscholar.org pdfs.semanticscholar.org/213c/5001ee6486b7aac87d1599b6331202d71741.pdf

Rethinking the effectiveness of defecation postures and ... The literature on posture for defecation has long recommended that if the hip joints are flexed (as in a squat position) this will increase the anorectal angle, ...