PEG3350 vs Senna After Urogyn Surgery

NCT06825260 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: StJosephNewYork
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

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

Conditions

Obstructive Defecation Syndrome; Postoperative Constipation

Keywords

obstructive defecation syndrome (ODS); Postoperative constipation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient-level and Procedure-level Characteristics associated with Postoperative ODS in Patients Taking PEG3350 vs Senna

  From enrollment to the end of treatment at 7 days after surgery.

Study Arms (2)

Senna

EXPERIMENTAL

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

Drug: Senna

Polyethylene Glycol 3350

ACTIVE COMPARATOR

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

Drug: Polyethylene glycol 3350

Interventions

Senna DRUG

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

Also known as: Senokot, Sennoside

Senna

Polyethylene glycol 3350 DRUG

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

Also known as: PEG 3350, Miralax

Polyethylene Glycol 3350

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• St. Joseph's Health, New York: lead

Study Sites (1)

St. Joseph's Health Hospital

Syracuse, New York, 13203, United States

RECRUITING

MeSH Terms

Interventions

Sennosides; polyethylene glycol 3350

Intervention Hierarchy (Ancestors)

Senna Extract; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quinones; Polycyclic Compounds; Glycosides; Carbohydrates; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Keila S Muniz, MD

  St. Joseph's Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keila S Muniz, MD

CONTACT

631-896-7937; keila.muniz@sjhsyr.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, St. Joseph's Physicians Urogynecology

Study Record Dates

• First Submitted: February 8, 2025
• First Posted: February 13, 2025
• Study Start: April 23, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 28, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)