PEG3350 vs Senna After Urogyn Surgery

Conditions

• Obstructive Defecation Syndrome
• Postoperative Constipation

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Senna — DRUG
  Senna, oral, 8.6mg, 2 tablets daily (up to 4 tablets twice a day) for 7 days
• Polyethylene glycol 3350 — DRUG
  Polyethylene Glycol 3350, oral, 17g, daily for 7 days

Study Details

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

Key Dates

Start date

Apr 23, 2025

Status verified

Apr 2025

Primary completion

Mar 31, 2027

Completion

Jul 31, 2027

Study Design

Enrollment

254 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Senna
  Senna (Sennosides), oral, 8.6mg, 2 tablets daily (up to 4 tablets twice a day) for 7 days
• Active Comparator: Polyethylene Glycol 3350
  Polyethylene Glycol 3350, oral, 17g, daily for 7 days

Primary Outcome Measure

Postoperative ODS in Patients Taking PEG3350 vs Senna [ Time Frame: From enrollment to the end of treatment at 7 days after surgery. ]

Central Contacts

• Keila S Muniz, MD
  631-896-7937
  [email protected]

Locations (1)

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