PEG3350 vs Senna for Constipation

Recruiting in Palo Alto (17 mi)

Overseen byKeila S Muniz, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: St. Joseph's Health, New York

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The goal of this study is to evaluate whether polyethylene glycol 3350 (PEG3350) versus senna is better at relieving postoperative constipation after urogynecologic surgery. The main questions it aims to answer are: What number of patients taking PEG3350 have obstructed defecation syndrome (ODS), a form of constipation, vs those taking senna in the week after urogynecologic surgery? What patient-level and procedure-level characteristics are associated with postoperative ODS, in patients taking PEG3350 vs senna? participants will: Take their randomized medication daily for seven days after surgery Fill out an ODS questionnaire before and one week after surgery Complete a daily bowel diary for 7 days after surgery

Eligibility Criteria

This trial is for individuals experiencing constipation after urogynecologic surgery. Participants will take a daily medication for seven days post-surgery and keep track of their bowel movements. They must be willing to fill out questionnaires before and after the treatment period.

Inclusion Criteria

I am a woman over 18 scheduled for surgery due to pelvic organ prolapse or stress urinary incontinence.

Exclusion Criteria

I am having surgery for bowel issues or getting a sacral neuromodulation device.

Participant Groups

The study compares two laxatives: PEG3350 and senna, to see which is more effective at preventing obstructive defecation syndrome (ODS) following urogynecologic surgery. Patients are randomly assigned one of these medications and monitored for a week.

2Treatment groups

Experimental Treatment

Active Control

Group I: SennaExperimental Treatment1 Intervention

Senna (Sennosides), oral, 8.6mg, 2 tablets daily (up to 4 tablets twice a day) for 7 days

Group II: Polyethylene Glycol 3350Active Control1 Intervention

Polyethylene Glycol 3350, oral, 17g, daily for 7 days