Posture Device for Easier Bowel Movements After Pelvic Surgery

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

160 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Defecation Posture Modification Device, Squatty Potty, Defecation Posture Modification Device, DPMD?

Research suggests that using a defecation posture modification device can help improve bowel movement patterns by mimicking the natural squatting position, which straightens the anorectal angle and relaxes the pelvic floor, making it easier to pass stool. ^{1 2 3 4 5}

Is the posture device for easier bowel movements after pelvic surgery safe for humans?

Research on defecation posture modification devices, like the Squatty Potty, suggests they are generally safe for use in humans, as they aim to improve bowel movement by helping people achieve a more natural squatting position. ^{1 2 3 4 6}

How does the Defecation Posture Modification Device differ from other treatments for easier bowel movements after pelvic surgery?

The Defecation Posture Modification Device, like the Squatty Potty, is unique because it modifies the sitting posture to facilitate bowel movements by aligning the body in a more natural squatting position, which can reduce strain and improve pelvic floor muscle activity. This approach is different from other treatments that may involve medication or surgical interventions, as it focuses on changing posture to enhance bowel function. ^{7 8 9 10 11}

What is the purpose of this trial?

This study will determine if defecation posture, when using a defecation posture modification device (DPMD), improves ease with first bowel movement following pelvic reconstructive surgery, specifically posterior repair.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

References

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

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

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

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

3. Germany pubmed.ncbi.nlm.nih.gov

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

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

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

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

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

6. 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]

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

Clinical measurement of pelvic floor movement: evaluation of a new device. [2004]

8. England pubmed.ncbi.nlm.nih.gov

Development and testing of a pelvic goniometer designed to measure pelvic tilt and hip flexion. [2019]

9. Australia pubmed.ncbi.nlm.nih.gov

Sitting posture affects pelvic floor muscle activity in parous women: an observational study. [2019]

10. England pubmed.ncbi.nlm.nih.gov

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

11. France pubmed.ncbi.nlm.nih.gov

[Auto-reeducation of female stress urinary incontinence]. [2007]