Posture Device for Easier Bowel Movements After Pelvic Surgery
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: TriHealth Inc.
Disqualifiers: Ileostomy, Colostomy, Wheelchair, Pregnancy, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
12346How 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.
7891011Eligibility 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.
+5 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Defecation Posture Modification DeviceExperimental Treatment1 Intervention
Group II: ControlActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cincinnati Urogynecology AssociatesCincinnati, OH
Good Samaritan HospitalCincinnati, OH
Bethesda North HospitalCincinnati, OH
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Who Is Running the Clinical Trial?
TriHealth Inc.Lead Sponsor
References
Implementation of a Defecation Posture Modification Device: Impact on Bowel Movement Patterns in Healthy Subjects. [2020]The goal of this study was to evaluate the influence of defecation postural modification devices (DPMDs) on normal bowel patterns.
Can a Defecation Posture Modifying Device Correct an Abnormal Balloon Expulsion Test in Chronically Constipated Patients? [2023]Evacuation disorders are common among chronically constipated (CC) patients who fail to respond to laxatives and are typically diagnosed by anorectal manometry (ARM) and/or balloon expulsion testing (BET).1,2 Recently, there has been emerging interest in the use of defecation posture-modifying devices (DPMDs) to improve constipation symptoms, presumably by replicating the physiologic benefits of squatting on stool evacuation, such as straightening of the anorectal angle and relaxing the pelvic floor. However, the ability of DPMDs to normalize anorectal function in adult patients with CC has not been studied.
Sacral Neuromodulation for defecation disorders after non oncologic pelvic surgery. [2023]Defecation disorders (DD) can sometimes affect the outcomes of pelvic or colorectal surgery. The aim of the present study is to evaluate the role of sacral neuromodulation for the treatment of constipation and other evacuation disorders after surgery.
Fecobionics assessment of the effect of position on defecatory efficacy in normal subjects. [2022]Defecation is a complex process and up to 25% of the population suffer from symptoms of defecatory dysfunction. For functional testing, diagnostics, and therapy of anorectal disorders, it is important to know the optimal defecation position. is The aim of this study was to evaluate defecation pressure patterns in side lying, seated and squatting defecation positions in normal subjects using a simulated stool device called Fecobionics.
Posterior compartment prolapse and perineal descent: systematic review of available support devices. [2023]The aim of our study is to systematically review the literature about available devices facilitating perineal support during defecation in patients with obstructive defecation syndrome (ODS) and posterior pelvic organ prolapse (POP).
A review on squat-assist devices to aid elderly with lower limb difficulties in toileting to tackle constipation. [2019]Constipation is an important issue that has impact on quality of life and health expenses of the elderly. It may lead to many other gastrointestinal disorders like colon cancer, haemorrhoids, anal fissures and so on. Squatting is considered to be the natural, traditional and most widely followed posture for defecation and hence, it is one of the practical solutions for avoiding constipation. Musculoskeletal issues due to ageing and changes in lifestyle make it difficult for the elder population to follow squatting or semi-squatting posture for defecation. Developing assistive devices to overcome older people's difficulty to attain squatting or semi-squatting posture is one of the research areas which need to be explored further. This review covers various designs of such devices which will enable a user to attain 'semi-squatting' posture to defecate and also addresses various challenges and limitations to overcome.
Clinical measurement of pelvic floor movement: evaluation of a new device. [2004]A new device that measures pelvic floor movement clinically was evaluated.
Development and testing of a pelvic goniometer designed to measure pelvic tilt and hip flexion. [2019]To determine the reliability and validity of a pelvic goniometer designed to measure the pelvic tilt and hip flexion during seated posture.
Sitting posture affects pelvic floor muscle activity in parous women: an observational study. [2019]Do different sitting postures require different levels of pelvic floor and abdominal muscle activity in healthy women?
Can different seating aids influence a sitting posture in healthy individuals and does gender matter? [2020]This study determined differences in spinal-pelvic kinematics sitting on (i) mat (ii) block and (iii) novel 10º forward inclined wedge (ButtaflyTM) in a same-subject repeated measures cross-over design in 60 healthy individuals (34 females). Repeated measures ANOVA revealed statistically significant differences between sitting conditions and lumbar and pelvic sagittal angles. Both, the inclined wedge and the block seating aids reduced overall flexion, but the inclined wedge had a greater influence in the lumbar region whilst the block induced the greatest change in the pelvis. This may be relevant for seating aid design personalised to posture type. Statistically significant gender differences were identified in all 3 seating conditions with males adopting more flexed lumbar spine and posteriorly tilted pelvis. Females flexed less in thoracic spine when sitting on an inclined wedge and a block. These statistically significant differences between males and females may provide first explorative direction for bespoke seating aids design.
[Auto-reeducation of female stress urinary incontinence]. [2007]The Pelvia device is the fruit of the latest anatomic, functional and physiotherapeutic research into the pelvic floor. Thanks to its sophisticated technology, Pelvia is a user-friendly device fully suited to today's lifestyle of women, allowing them to do self-retraining exercises of the perineal muscles as an adjunct to the other therapies available. It is a reliable method to make patients aware of the strength and improvement of th perineal muscles contraction. It has nothing to do with "vaginal weight cones". This method is based on feedback, but the weight of the device itself does not only increase awareness but allows patients to increase their muscular strength. 30 women with stress urinary incontinence followed the protocol of self-retraining. All of them presented the following symptoms: urinary leakage, urethral urinary incontinence due to urethral hypermobility or sphincteral insufficiency, a perineum muscular testing below 4. After retraining the results were as follows: 17 cases of cure (57%); 9 cases (30%) were improved without full disappearance of incontinence; 4 cases failed (13%). The average follow-up period is 10 months (2-22). The results observed in 30 women seem promising. Of course this is only a small series and results need confirming by studying a larger series with a longer follow-up.