Laxative for Pelvic Prolapse Surgery

Overseen By Gabriella M Rustia, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University Hospitals Cleveland Medical Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

74 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 4 5 6}

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. ^{1 2 4 5 7}

Research Team

David Sheyn

Principal Investigator

University Hospitals Cleveland Medical Center

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.

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

Treatment Details

Interventions

• Polyethylene Glycol 3350

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Findings from Research

In a study involving 23 patients with constipation, daily treatment with 17 g of polyethylene glycol (PEG) laxative significantly increased bowel movement frequency to once per day compared to a placebo, which resulted in about one bowel movement every two days.

The PEG treatment not only improved bowel movement frequency but also enhanced patients' subjective symptoms related to constipation, with no significant adverse effects observed in blood chemistry or other health markers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New polyethylene glycol laxative for treatment of constipation in adults: a randomized, double-blind, placebo-controlled study. Cleveland, MV., Flavin, DP., Ruben, RA., et al.[2018]

In a study of 304 patients with chronic constipation, PEG 3350 (MiraLAX) was found to be significantly more effective than placebo, with 52% of PEG users achieving treatment success compared to only 11% of those on placebo (P < 0.001).

The study demonstrated that PEG laxative is safe for long-term use, as there were no significant differences in adverse events or laboratory findings compared to placebo, although some gastrointestinal side effects like diarrhea and nausea were reported more frequently with PEG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, multicenter, placebo-controlled trial of polyethylene glycol laxative for chronic treatment of chronic constipation. Dipalma, JA., Cleveland, MV., McGowan, J., et al.[2022]

In a study involving 151 constipated but otherwise healthy outpatients, Braintree polyethylene glycol (PEG) laxative significantly increased bowel movement frequency compared to a placebo, with an average of 4.5 movements per week in the PEG group versus 2.7 in the placebo group by week 2.

The PEG laxative was found to be safe, with no significant differences in laboratory results or adverse effects between the treatment and placebo groups, indicating its suitability for short-term use in treating constipation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, placebo-controlled, multicenter study of the safety and efficacy of a new polyethylene glycol laxative. DiPalma, JA., DeRidder, PH., Orlando, RC., et al.[2022]

In a study involving 311 patients, including 117 elderly individuals, polyethylene glycol 3350 (MiraLAX) was found to be safe and effective for treating chronic constipation over a 12-month period, with 80-88% of patients reporting successful treatment outcomes.

The treatment was associated with mild to moderate gastrointestinal side effects, such as diarrhea and nausea, but there were no significant changes in blood chemistry or hematology, indicating a favorable safety profile for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open-label study of chronic polyethylene glycol laxative use in chronic constipation. Di Palma, JA., Cleveland, MV., McGowan, J., et al.[2018]

Polyethylene glycol 3350 (MiraLAX) is an effective and safe osmotic laxative for treating chronic constipation in both children and adults, supported by 21 clinical studies involving 1949 patients.

The American College of Gastroenterology has given polyethylene glycol 3350 a grade A recommendation for its ability to improve stool frequency and consistency, indicating strong clinical support for its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Over-the-counter laxative polyethylene glycol 3350: an evidence-based appraisal. Zurad, EG., Johanson, JF.[2019]

A 7-year-old child developed acute kidney injury and altered mental status after using generic PEG 3350, suggesting possible contamination with ethylene glycol, which can lead to serious health issues.

The child's condition improved after treatment, highlighting the importance of recognizing potential contamination in PEG 3350 products, especially when symptoms like metabolic acidosis and kidney injury occur.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polyethylene Glycol 3350 Crystal Nephropathy in Association With Glomerular Mesangial Immunoglobin A Deposition. Aly, R., Acharya, R., Zeng, X., et al.[2022]

In a study involving 156 patients with chronic constipation, PEG3350 plus electrolytes (PEG3350 + E) significantly increased the frequency of spontaneous bowel movements compared to placebo, demonstrating its efficacy in resolving constipation.

The long-term use of PEG3350 + E over 52 weeks was well tolerated, with only mild gastrointestinal side effects reported, indicating its safety for chronic use in managing constipation.

NCBI (Pubmed)

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. Nakajima, A., Shinbo, K., Oota, A., et al.[2020]

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]

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]

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]

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

An open-label study of chronic polyethylene glycol laxative use in chronic constipation. [2018]

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

Over-the-counter laxative polyethylene glycol 3350: an evidence-based appraisal. [2019]

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

Polyethylene Glycol 3350 Crystal Nephropathy in Association With Glomerular Mesangial Immunoglobin A Deposition. [2022]

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]