Clinical trial NCT06825260: PEG3350 vs Senna After Urogyn Surgery
Official title: Polyethylene Glycol 3350 Compared With Senna After Urogynecologic Surgery A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Obstructive Defecation Syndrome
Postoperative Constipation
Keywords: obstructive defecation syndrome (ODS)
Postoperative constipation
Lead sponsor: St. Joseph's Health, New York
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 254
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: The purpose of this study is to evaluate whether polyethylene glycol 3350 (PEG3350) versus senna is superior in the setting of postoperative constipation after urogynecologic surgery. This is a randomized controlled trial with the aim of comparing PEG3350 vs senna as postoperative recommended treatment for obstructive defecation constipation. Our hypothesis is that senna decreases the proportion of women with obstructive defecation constipation compared to use of PEG3350 after urogynecologic surgery. Women 18 years of age and older undergoing surgery for pelvic organ prolapse, stress urinary incontinence or both by the Department of Urogynecology at St. Joseph's Health Hospital, will be randomized to one of two study arms: senna or PEG3350. Arm 1: Polyethylene Glycol 3350, 17g, daily, oral. Arm 2: Senna (Sennosides) 8.6mg, 2 tablets daily, oral (up to 4 tablets twice a day). Interventions would be administered after surgery on postoperative day #0 and continue for 7 days total.

Eligibility 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.

Primary outcomes:
measure: Postoperative ODS in Patients Taking PEG3350 vs Senna
timeFrame: From enrollment to the end of treatment at 7 days after surgery.
Secondary outcomes:
measure: Patient-level and Procedure-level Characteristics associated with Postoperative ODS in Patients Taking PEG3350 vs Senna
timeFrame: From enrollment to the end of treatment at 7 days after surgery.
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: St. Joseph's Health Hospital
state: New York
Study officials:
affiliation: St. Joseph's Health
name: Keila S Muniz, MD
role: PRINCIPAL_INVESTIGATOR
References: