Comparing PEG3350 and Senna for Constipation Relief After Urogyn Surgery
Polyethylene Glycol 3350 Compared With Senna After Urogynecologic Surgery A Randomized Controlled Trial
This study tests whether a new laxative called PEG3350 works better than senna to help women with constipation after urogynecologic surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 254 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | St. Joseph's Health, New York Academic / other |
| Locations | 1 site (Syracuse, New York) |
| Trial ID | NCT06825260 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of polyethylene glycol 3350 (PEG3350) versus senna in relieving postoperative constipation in women after urogynecologic surgery. Participants will be randomly assigned to receive either PEG3350 or senna for seven days following their surgery. They will complete an obstructive defecation syndrome (ODS) questionnaire and maintain a daily bowel diary to track their symptoms. The study aims to determine which treatment is more effective in reducing the incidence of obstructed defecation syndrome in the postoperative period.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older scheduled for urogynecologic surgery for pelvic organ prolapse or stress urinary incontinence.
Not a fit: Patients undergoing concomitant bowel surgery or placement of a sacral neuromodulation device will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for postoperative constipation, improving recovery and quality of life for patients.
How similar studies have performed: Previous studies have explored treatments for postoperative constipation, but this specific comparison of PEG3350 and senna is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Inclusion criteria includes women scheduled for urogynecologic surgery for pelvic organ prolapse and/or stress urinary incontinence and at least 18 years old. Exclusion Criteria: * Exclusion criteria include undergoing concomitant bowel surgery (colonic resection, anal sphincter repair, rectovaginal fistula repair, rectopexy) or placement of a sacral neuromodulation device alone.
Where this trial is running
Syracuse, New York
- St. Joseph's Health Hospital — Syracuse, New York, United States (Recruiting)
Study contacts
- Principal investigator: Keila S Muniz, MD — St. Joseph's Health
- Study coordinator: Keila S Muniz, MD
- Email: keila.muniz@sjhsyr.org
- Phone: 631-896-7937
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.