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PEG3350 vs Senna After Urogyn Surgery

NCT06825260 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2025-05-28

No results posted yet for this study

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

Conditions

  • Obstructive Defecation Syndrome
  • Postoperative Constipation

Interventions

DRUG

Senna

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

DRUG

Polyethylene glycol 3350

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

Sponsors & Collaborators

  • St. Joseph's Health, New York

    lead OTHER

Principal Investigators

  • Keila S Muniz, MD · St. Joseph's Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-23
Primary Completion
2027-03-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06825260 on ClinicalTrials.gov