Laxative for Pelvic Prolapse Surgery

Recruiting in Palo Alto (17 mi)

Overseen by David Sheyn

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University Hospitals Cleveland Medical Center

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to test the use of a laxative before surgery in women having surgery to fix pelvic prolapse that do not have constipation. The main question it aims to answer is: Does use of a laxative before surgery lessen the discomfort of bowel movements after surgery? Participants will be asked to complete questionnaires before and after surgery. Researchers will compare using the laxative before and after surgery versus only after surgery to see if there is less discomfort with bowel movements after surgery.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using a laxative at least once a week for constipation, you cannot participate in the trial.

What data supports the idea that Laxative for Pelvic Prolapse Surgery (also known as: Polyethylene Glycol 3350, MiraLAX, Polyethylene Glycol 3350, PEG 3350) is an effective treatment?

The available research shows that Polyethylene Glycol 3350, commonly known as MiraLAX, is effective for treating constipation. Several studies have demonstrated its safety and effectiveness in relieving constipation. For example, one study found that it was effective over a 6-month period for people with chronic constipation. While these studies focus on constipation, they suggest that the drug can help manage bowel movements, which is important for recovery after pelvic prolapse surgery.

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What safety data is available for polyethylene glycol 3350 (MiraLAX) as a laxative?

Polyethylene glycol 3350 (MiraLAX) is approved for short-term treatment of occasional constipation. Safety data includes studies on its use for chronic constipation, showing it is generally safe over a 6-month period. However, there are rare reports of potential contamination leading to serious side effects, such as acute kidney injury and metabolic acidosis, as seen in a case involving a child. Further studies are needed to explore these rare occurrences.

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Is the drug Polyethylene Glycol 3350 (MiraLAX) a promising treatment for pelvic prolapse surgery?

Polyethylene Glycol 3350 (MiraLAX) is a well-known laxative that is effective for treating constipation. It is widely used and has been shown to be safe and effective in various studies. This suggests it could be a promising option for managing constipation-related issues after pelvic prolapse surgery.

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Eligibility Criteria

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.

Inclusion Criteria

I am a patient assigned female at birth and am scheduled for a pelvic organ prolapse surgery with additional urogynecologic procedures.

I am scheduled for a surgery that will start with a less invasive approach.

Exclusion Criteria

Allergy or intolerance to polyethylene glycol 3350

I have been diagnosed with cancer before.

I have been diagnosed with a bowel disorder such as IBS or constipation.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-operative

Participants in the experimental group take 17 grams of PEG every day starting 3 days prior to scheduled surgery date

3 days

1 visit (in-person) for surgery preparation

Post-operative

Participants take 17 grams of PEG every day for 7 days starting the day of surgery. Participants can adjust the dose as needed and record all doses used.

1 week

1 visit (in-person) for surgery, follow-up via questionnaires

Follow-up

Participants are monitored for constipation symptoms and other outcomes using questionnaires at 1 and 2 weeks post-operative

2 weeks

Questionnaires at 1 and 2 weeks post-operative

Participant Groups

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.

Group I: Pre-operative Experimental Treatment 1 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-operative Active Control 1 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.

Polyethylene Glycol 3350 is already approved in United States, Canada, European Union for the following indications:

🇺🇸 Approved in United States as MiraLAX for:

• Constipation
• Bowel preparation for colonoscopy or surgery

🇨🇦 Approved in Canada as Polyethylene Glycol 3350 for:

• Constipation
• Bowel preparation for colonoscopy or surgery

🇪🇺 Approved in European Union as Macrogol 3350 for:

• Constipation
• Faecal impaction
• Bowel preparation for colonoscopy or surgery

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University Hospitals Cleveland Medical Center Cleveland, OH

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

New polyethylene glycol laxative for treatment of constipation in adults: a randomized, double-blind, placebo-controlled study. [2018] This study evaluated the safety and effectiveness of a new polyethylene glycol (PEG) laxative (MiraLax, Braintree Laboratories Inc, Braintree, Mass) in 23 patients reporting a history of constipation.

2. United States pubmed.ncbi.nlm.nih.gov

A randomized, multicenter, placebo-controlled trial of polyethylene glycol laxative for chronic treatment of chronic constipation. [2022] Polyethylene glycol (PEG) 3350 (MiraLAX) is currently approved for the short-term treatment of occasional constipation. This study was designed to compare the safety and efficacy of PEG laxative versus placebo over a 6-month treatment period in patients with chronic constipation.

3. United States pubmed.ncbi.nlm.nih.gov

A randomized, placebo-controlled, multicenter study of the safety and efficacy of a new polyethylene glycol laxative. [2022] This study was designed to determine the efficacy and safety of a new laxative, Braintree polyethylene glycol (PEG) laxative (Miralax, Braintree Laboratories, Braintree, MA).

4. England pubmed.ncbi.nlm.nih.gov

An open-label study of chronic polyethylene glycol laxative use in chronic constipation. [2018] Polyethylene glycol 3350 (MiraLAX, Braintree Laboratories Inc., Braintree, MA, USA) is approved for the short-term treatment of occasional constipation.

5. England pubmed.ncbi.nlm.nih.gov

Over-the-counter laxative polyethylene glycol 3350: an evidence-based appraisal. [2019] To explore the clinical dimensions of chronic constipation and the role played in its treatment by laxatives in general and by polyethylene glycol 3350 (MiraLAX * ) in particular. * MiraLAX is a registered trade name of Schering-Plough HealthCare Products, Inc., Memphis, TN, USA, a subsidiary of Merck & Co., Inc.

6. Canada pubmed.ncbi.nlm.nih.gov

Polyethylene Glycol 3350 Crystal Nephropathy in Association With Glomerular Mesangial Immunoglobin A Deposition. [2022] Polyethylene glycol (PEG) 3350, an active ingredient of over-the-counter MiraLAX, is a commonly used laxative in children and is produced by polymerization of ethylene glycol (EG). Masked EG toxicity secondary to contamination of PEG 3350 could occur. We present a 7-year-old child with developmental delay who presented with altered mental status and acute kidney injury (AKI) following intake of generic PEG 3350 for few days prior to presentation. There was high anion gap metabolic acidosis, hypernatremia, elevated osmolar gap, lactic acidosis, and AKI. Urinalysis showed tubular proteinuria, microscopic hematuria, and calcium oxalate crystals. Prior urinalyses were normal without hematuria or proteinuria. Renal biopsy revealed evidence of mesangial dominant immunoglobulin A (IgA) and complement 3 (C3) deposits along with dense tubular deposition of calcium oxalate crystals. He subsequently developed worsening oliguric AKI and required hemodialysis (HD) for several sessions. The AKI resolved within 2 weeks and further HD was not required. Mental status improved in few days. Follow-up urinalyses showed resolution of microscopic hematuria and crystalluria. We hypothesized that the generic PEG 3350 most likely was contaminated with EG leading to the presentation. A high index of suspicion of contamination of PEG 3350 with EG is required in patients presenting with unexplained high anion gap metabolic acidosis, elevated osmolar gap, lactic acidosis, AKI, calcium oxalate crystalluria, and oxalate crystals on renal biopsy. Further studies are needed to determine whether there is an association between transient glomerular mesangial IgA deposition and crystal nephropathy.

7. Japan pubmed.ncbi.nlm.nih.gov

Polyethylene glycol 3350 plus electrolytes for chronic constipation: a 2-week, randomized, double-blind, placebo-controlled study with a 52-week open-label extension. [2020] Although polyethylene glycol 3350 plus electrolytes (PEG3350 + E) is the most widely used osmotic laxative in Europe, prospective data on its long-term (over 6 months) safety and efficacy are not available to date.