PEG3350 vs Senna After Urogyn Surgery

Polyethylene Glycol 3350 Compared With Senna After Urogynecologic Surgery A Randomized Controlled 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

Study Overview

• Status: Recruiting
• Conditions: Obstructive Defecation Syndrome; Postoperative Constipation
• Intervention / Treatment: Drug: Senna; Drug: Polyethylene glycol 3350

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.

• Study Type: Interventional
• Enrollment (Estimated): 254
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Keila S Muniz, MD; Phone Number: 631-896-7937; Email: keila.muniz@sjhsyr.org

Study Locations

• United States
  • New York
    • Syracuse, New York, United States, 13203
      • Recruiting
      • St. Joseph's Health Hospital
      • Contact: Keila S Muniz, MD; Phone Number: 631-896-7937; Email: keila.muniz@sjhsyr.org
      • Principal Investigator: Keila S Muniz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Senna; Senna (Sennosides), oral, 8.6mg, 2 tablets daily (up to 4 tablets twice a day) for 7 days	Drug: Senna; Senna, oral, 8.6mg, 2 tablets daily (up to 4 tablets twice a day) for 7 days; Other Names: Senokot; Sennoside
Active Comparator: Polyethylene Glycol 3350; Polyethylene Glycol 3350, oral, 17g, daily for 7 days	Drug: Polyethylene glycol 3350; Polyethylene Glycol 3350, oral, 17g, daily for 7 days; Other Names: Miralax; PEG 3350

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative ODS in Patients Taking PEG3350 vs Senna	The primary outcome is to determine the proportion of patients with postoperative obstructed defecation syndrome (ODS), defined as a score of nine or greater on the ODS questionnaire, in patients taking PEG3350 vs senna in the week after urogynecologic surgery.	From enrollment to the end of treatment at 7 days after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-level and Procedure-level Characteristics associated with Postoperative ODS in Patients Taking PEG3350 vs Senna	In order to identify postoperative bowel symptoms associated with ODS, enrolled participants will complete a bowel diary for 7 days after surgery. The bowel diary will include: type of bowel movement using the validated Bristol stool scale, degree of strain and pain measured on an 11-point numerical rating scale from 0-10 (zero denoting no presence of symptom and ten denoting the most severe symptom experienced), presence of splinting with bowel movements, sensation of incomplete evacuation (measured on an 11-point numerical rating scale from 0-10), additional medications taken to assist with bowel movements, fecal urgency, fecal incontinence, narcotic medication usage as well as time to first bowel movement. ODS score will be obtained preoperatively. Participants will be asked to estimate their preoperative frequency of bowel movements. Patients will self-identify their racial background. Medical records will be reviewed to obtain patient characteristics and perioperative data.	From enrollment to the end of treatment at 7 days after surgery.

Collaborators and Investigators

• Sponsor: St. Joseph's Health, New York
• Investigators: Principal Investigator: Keila S Muniz, MD, St. Joseph's Health

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: February 8, 2025
• First Submitted That Met QC Criteria: February 8, 2025
• First Posted (Actual): February 13, 2025

Study Record Updates

• Last Update Posted (Actual): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 21, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Postoperative constipation; obstructive defecation syndrome (ODS)
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Gastrointestinal Agents; Laxatives; Polyethylene glycol 3350; Sennosides
• Other Study ID Numbers: StJosephNewYork

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes