PEG3350 vs Senna After Urogyn Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSt. Joseph's Health, New York
About this 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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Inclusion criteria includes women scheduled for urogynecologic surgery for pelvic organ prolapse and/or stress urinary incontinence and at least 18 years old.
Disqualifiers
Exclusion criteria include undergoing concomitant bowel surgery (colonic resection, anal sphincter repair, rectovaginal fistula repair, rectopexy) or placement of a sacral neuromodulation device alone.
Trial design
Design model
Parallel
Treatments tested in this trial
Senna
DrugSenna, oral, 8.6mg, 2 tablets daily (up to 4 tablets twice a day) for 7 days
Polyethylene glycol 3350
DrugPolyethylene Glycol 3350, oral, 17g, daily for 7 days
Treatment groups
254 Participants
are divided into 2 treatment groupsGroup A: SennaExperimental treatment 1 intervention
Group B: Polyethylene Glycol 3350Active comparator 1 intervention
Trial outcomes
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.
Time frame
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
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.
Time frame
From enrollment to the end of treatment at 7 days after surgery.Sponsors and contacts
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Source ClinicalTrials.gov