Using a laxative before surgery for pelvic prolapse in women
Pre- and Post-operative Compared to Post-operative Only Polyethylene Glycol 3350 for Minimally Invasive Urogynecologic Surgery
This study is testing whether giving a laxative before surgery helps women with pelvic prolapse feel less discomfort during bowel movements after the procedure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | Female |
| Sponsor | University Hospitals Cleveland Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06159777 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of administering polyethylene glycol 3350, a laxative, before surgery in women undergoing procedures for pelvic organ prolapse. The study will compare the discomfort experienced during bowel movements after surgery between two groups: one receiving the laxative pre-operatively and the other receiving it post-operatively. Participants will complete questionnaires before and after their surgeries to assess their experiences. The trial is designed as a multi-institution, single-blind, randomized control study to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are women assigned female sex at birth who are scheduled for minimally invasive surgery to correct pelvic organ prolapse.
Not a fit: Patients with pre-existing conditions such as irritable bowel syndrome or symptomatic constipation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce post-operative bowel discomfort for women undergoing pelvic prolapse surgery.
How similar studies have performed: While the specific use of pre-operative laxatives in this context may be novel, similar studies have shown that pre-operative bowel management can improve post-operative outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients assigned female sex at birth undergoing an apical prolapse procedure including: sacrocolpopexy, sacrospinous ligament suspension, uterosacral ligament suspension, or colpocleisis. Planned urogynecologic procedure may include hysterectomy, adnexectomy, colporrhaphy, perineorrhaphy, or treatment of stress urinary incontinence. * Planning to undergo primary procedure as above via minimally invasive route: vaginal or laparoscopic (including robotic-assisted). Including those that have an unplanned conversion intraoperatively of minimally invasive route to open laparotomy. Exclusion Criteria: * Diagnosis of irritable bowel syndrome, inflammatory bowel disease, slow transit constipation, obstructed defecation, or symptomatic constipation at time of study screening and recruitment. (Slow transit constipation and obstructed defecation defined as per American Gastroenterological Association 2013 constipation statement. Symptomatic constipation defined as any of the following: Bristol Stool Scale score of 1 or 2, PAC-SYM score greater than 1.0, self-reported 2 or less bowel movements per week.) * Current use of pharmacologic laxative agent ≥1x/week (prescription or OTC) for the treatment of constipation symptoms * Allergy or intolerance to polyethylene glycol 3350 * Planning to undergo surgery via laparotomy * Scheduled for any concurrent non-urogynecologic procedure, ex abdominoplasty * History of large bowel resection, surgical treatment of constipation, or anal sphincter surgery * History of sacral neuromodulation * Current or prior radiation therapy to the abdomen or pelvis * Current or prior diagnosis of malignancy * Unable to provide informed consent
Where this trial is running
Cleveland, Ohio
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: David Sheyn, MD — University Hospitals Cleveland Medical Center
- Study coordinator: Gabriella M Rustia, MD
- Email: gabriella.rustia@uhhospitals.org
- Phone: 216-202-0597
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.