Defecation Posture Device for Rectocele
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.
Must not be taking: Opiates
Disqualifiers: Bowel disease, Wheelchair bound, others
No Placebo Group
Approved in 2 Jurisdictions
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.
12345Is 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.
12467How 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.
12347Eligibility 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
+9 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 bowel movements
2 weeks
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
2 weeks
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Defecation Posture Modification DeviceExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Bethesda North HospitalCincinnati, OH
Good Samaritan HospitalCincinnati, OH
Cincinnati Urogynecology AssociatesCincinnati, OH
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Who Is Running the Clinical Trial?
TriHealth Inc.Lead Sponsor
References
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.
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.
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).
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.
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.
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.
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.