Posture Device for Easier Bowel Movements After Pelvic Surgery

No longer recruiting at 2 trial locations

Overseen By Jennifer Hodge

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: TriHealth Inc.

Disqualifiers: Ileostomy, Colostomy, Wheelchair, Pregnancy, 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: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special device that changes sitting position can ease bowel movements after pelvic surgery, particularly for those who have undergone posterior repair. Participants will either use the Defecation Posture Modification Device (also known as Squatty Potty) or follow their usual routine to assess any differences in the ease of their first bowel movement post-surgery. Individuals undergoing pelvic surgery by a specific group of surgeons who have not previously used a similar device may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance post-surgery recovery for future patients.

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

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 after pelvic surgery?

Research shows that a Defecation Posture Modification Device (DPMD) can ease bowel movements. Studies have found that this device helps users empty their bowels more completely and with less effort, making bathroom visits more comfortable.

No reports indicate unsafe outcomes from using this device. It positions the body in a more natural way for defecation, similar to using a footstool to mimic a squatting position, a method used for centuries.

While specific data on harmful effects is lacking, the device's design and purpose suggest safety. Remember, it aids posture and is not a medication or surgery. For concerns, consulting a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Defecation Posture Modification Device because it offers a new, non-invasive way to improve bowel movements after pelvic surgery. Unlike traditional treatments that might involve medication or dietary changes, this device focuses on altering posture to enhance the natural mechanics of defecation. By optimizing the angle and position during bowel movements, the device aims to reduce strain and discomfort, potentially leading to quicker recovery and better outcomes for patients. This approach is unique because it harnesses the body's natural alignment without the need for drugs or surgical intervention.

What evidence suggests that this defecation posture modification device is effective for easier bowel movements after pelvic surgery?

Research shows that a Defecation Posture Modification Device (DPMD), which participants in this trial may use, can ease bowel movements by altering sitting position. Studies have found that people using a DPMD strained less and spent less time on the toilet. Specifically, the device helped users feel more completely empty after using the bathroom, making them over three times more likely to feel fully relieved. One study showed that the time spent on bowel movements decreased from about 5.6 minutes to around 4.24 minutes with the device. These results were observed in healthy individuals, suggesting the device might also facilitate the first bowel movement after pelvic surgery. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals who have recently undergone pelvic reconstructive surgery, specifically posterior repair, and are experiencing difficulty with their first bowel movement post-surgery.

Inclusion Criteria

I am having surgery with a focus on the back part of my pelvic area by one of the study's doctors.

Exclusion Criteria

Anyone currently using a defecation posture modification device

Patients weighing over 250 lbs, as per device manufacturer guidelines

The device could be a fall or safety risk for me.

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 first bowel movement following pelvic reconstructive surgery

1 week

Post-surgery monitoring

Follow-up

Participants are monitored for stool consistency, use of laxatives and pain medication, and satisfaction with the device

1 month

Questionnaire and diary logs

What Are the Treatments Tested in This Trial?

Interventions

• Defecation Posture Modification Device

Trial Overview The study is testing whether a defecation posture modification device (DPMD) can make it easier for patients to have their first bowel movement after pelvic organ prolapse surgery.

How Is the Trial Designed?

Group I: Defecation Posture Modification Device Experimental Treatment 1 Intervention

Group II: Control Active Control 1 Intervention

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

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]

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]

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]

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 eight healthy women, pelvic floor muscle activity significantly increased in unsupported sitting postures compared to supported sitting, indicating that posture affects pelvic floor engagement.

Specifically, pelvic floor muscle activity rose from 7.2% in slump supported sitting to 12.6% in upright unsupported sitting and 24.3% in very tall unsupported sitting, suggesting that maintaining an upright posture may enhance pelvic floor strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sitting posture affects pelvic floor muscle activity in parous women: an observational study. Sapsford, RR., Richardson, CA., Stanton, WR.[2019]

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 Pelvia device effectively aids in self-retraining exercises for the pelvic floor muscles, showing promising results in a study of 30 women with stress urinary incontinence, where 57% experienced complete cure and 30% showed improvement.

The device enhances awareness and strength of perineal muscle contractions, distinguishing itself from traditional methods like vaginal weight cones, but further research with larger groups and longer follow-up is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Auto-reeducation of female stress urinary incontinence]. Mauroy, B., Devillers, P., Bonnal, JL., et al.[2007]

The pelvic goniometer has been validated as a reliable tool for measuring pelvic tilt and hip flexion angles in seated postures, showing strong correlation with radiographic measures (correlation coefficients of 0.93 for pelvic tilt and 0.81 for hip angle).

This new goniometer offers advantages over traditional goniometers by measuring both pelvic tilt and hip angle, making it particularly useful for clinical applications such as wheelchair seating evaluations and ergonomic assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and testing of a pelvic goniometer designed to measure pelvic tilt and hip flexion. Sprigle, S., Flinn, N., Wootten, M., et al.[2019]

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]

A new device for measuring pelvic floor movement was tested on 28 healthy volunteers, showing good reproducibility and minimal discomfort during use.

The device could be beneficial for pelvic floor training, as it effectively measures movements and allows for biofeedback, although one participant experienced a vasovagal reaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical measurement of pelvic floor movement: evaluation of a new device. Morren, GL., Ryn, AK., Hallböök, O., et al.[2004]

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. 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% ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06253689/impact-of-defecation-posture-on-ease-of-first-bowel-movement-following-posterior-repair?q=prolapse

Impact of Defecation Posture on Ease of First Bowel ... This study will determine if defecation posture, when using a defecation posture modification device (DPMD), improves ease with first bowel ...

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

Impact on Bowel Movement Patterns in Healthy Subjects Utilizing the DPMD resulted in increased bowel emptiness (odds ratio, 3.64; 95% confidence interval (CI), 2.78-4.77) and reduced straining patterns (odds ratio, ...

5. empr.com empr.com/home/news/defecation-posture-modification-device-found-to-be-beneficial/

Defecation Posture Modification Device Found to Be ... For DMPD versus non-DMPD bowel movements, there were significant reductions in duration (4.24 versus 5.6 minutes), reduced straining patterns ( ...

6. verywellhealth.com verywellhealth.com/squatty-potty-8419923

Squatty Potty: 5 Benefits of an Angled Pooping Position The Squatty Potty is a toilet footstool designed to mimic a natural squatting position that may promote faster, more complete bowel movements (poop).

7. clinicaltrial.be clinicaltrial.be/en/details/425084?only_active=0&only_eligible=0&only_recruiting=0&per_page=20

Impact of Defecation Posture on Ease of First Bowel Movem... This study will determine if defecation posture, when using a defecation posture modification device (DPMD), improves ease with first bowel ...

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

Rethinking the effectiveness of defecation postures and ... The pedestal toilet involves the user sitting with an upright posture on a chair-like structure with knees at right angles (dependant on height of seat and the ...