Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
254 participants
INTERVENTIONAL
2025-04-23
2027-07-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Senna
Senna (Sennosides), oral, 8.6mg, 2 tablets daily (up to 4 tablets twice a day) for 7 days
Senna
Senna, oral, 8.6mg, 2 tablets daily (up to 4 tablets twice a day) for 7 days
Polyethylene Glycol 3350
Polyethylene Glycol 3350, oral, 17g, daily for 7 days
Polyethylene glycol 3350
Polyethylene Glycol 3350, oral, 17g, daily for 7 days
Interventions
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Senna
Senna, oral, 8.6mg, 2 tablets daily (up to 4 tablets twice a day) for 7 days
Polyethylene glycol 3350
Polyethylene Glycol 3350, oral, 17g, daily for 7 days
Other Intervention Names
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Eligibility Criteria
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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.
18 Years
FEMALE
Yes
Sponsors
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St. Joseph's Health, New York
OTHER
Responsible Party
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Keila S. Muniz, MD
Physician, St. Joseph's Physicians Urogynecology
Principal Investigators
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Keila S Muniz, MD
Role: PRINCIPAL_INVESTIGATOR
St. Joseph's Health
Locations
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St. Joseph's Health Hospital
Syracuse, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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StJosephNewYork
Identifier Type: -
Identifier Source: org_study_id
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