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Laxative

Laxative for Pelvic Prolapse Surgery

Phase 4

Recruiting

Led By David Sheyn, MD

Research Sponsored by University Hospitals Cleveland Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week post-operative, 2 weeks post-operative

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to see if giving women a laxative before surgery for pelvic prolapse reduces discomfort with bowel movements after surgery. Participants will complete questionnaires before and after surgery to compare the effects of using

Who is the study for?

This trial is for women who are planning to have minimally invasive surgery (vaginal or laparoscopic, including robotic-assisted) to correct pelvic prolapse. It includes those who might need an unplanned switch to open surgery during the procedure. Participants should be undergoing procedures like sacrocolpopexy or uterosacral ligament suspension and may also have additional related surgeries.

What is being tested?

The study tests whether taking a laxative called Polyethylene Glycol 3350 before pelvic prolapse surgery can reduce discomfort in bowel movements post-surgery compared to only using it after the operation. Women will fill out questionnaires about their bowel movement comfort levels before and after surgery.

What are the potential side effects?

Polyethylene Glycol 3350 is a laxative that could cause side effects such as bloating, gas, upset stomach, dizziness, or increased thirst if taken before surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week post-operative, 2 weeks post-operative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week post-operative, 2 weeks post-operative

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week post-operative, 2 weeks post-operative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PAC-SYM

Secondary study objectives

Doses of PEG used

Rescue laxative use

Satisfaction with pain after surgery

+1 more

Side effects data

From 2017 Phase 4 trial • 276 Patients • NCT03060512

Flatulence

Nausea

Abdominal pain

Urinary tract infection

Abdominal pain upper

Diarrhoea

Vertigo

Gastroenteritis

Laceration

Vomiting

Abdominal distension

Back pain

100%

80%

60%

40%

20%

Study treatment Arm

PEG 3350

Movantik

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pre-operativeExperimental Treatment1 Intervention

Participants will be instructed to take 17 grams of powder Polyethylene glycol 3350 (PEG) every day starting 3 days prior to scheduled surgery date and continue to take 17 grams of PEG every day for 7 days following the day of surgery. Participants will be allowed to titrate up or down the amount of PEG used as needed and instructed to record all doses of PEG used.

Group II: Post-operativeActive Control1 Intervention

Participants will be instructed to take 17 grams of powder PEG\* every day for 7 days starting the day of surgery. Participants will be allowed to titrate up or down the amount of PEG used as needed and instructed to record all doses of PEG used.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Polyethylene Glycol 3350

2023

Completed Phase 4

~510

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