Personalizable Pessary for Pelvic Organ Prolapse

(NPP-POP Trial)

Overseen By Laura Reyes Martinez, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Pregnancy, Infections, Tumors, others

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

Compensation: Varies

Number of Visits: 4

43 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it focuses on using a new pessary for pelvic organ prolapse, so it might not affect your medication use.

What data supports the effectiveness of the treatment Personalizable Pessary for Pelvic Organ Prolapse?

The research indicates that pessaries, which are devices inserted into the vagina to support pelvic organs, have been studied for their success rates and factors affecting their fitting in women with pelvic organ prolapse. While the studies focus on fitting success and continuation rates, they suggest that pessaries can be a viable option for managing symptoms of pelvic organ prolapse. ^{1 2 3 4 5}

Is the personalizable pessary safe for humans?

The studies on vaginal pessaries, which are similar devices, mainly focus on fitting success and dislodgment rather than safety issues, suggesting that significant safety concerns are not commonly reported. ^{3 6 7 8 9}

What makes the Personalizable Pessary treatment unique for pelvic organ prolapse?

The Personalizable Pessary is unique because it can be customized to fit each woman's unique anatomy using three-dimensional printing technology, which may improve comfort and effectiveness compared to standard pessaries that often have a poor fit. ^{1 2 3 10 11}

What is the purpose of this trial?

Pelvic organ prolapse (POP) is a common health issue. It will impact about half of Canadian women over their lifetime. With POP, organs like the bladder, uterus, and bowel may push into the vagina. Women may experience urine leakage, physical discomfort, and embarrassment. Aside from surgery, a common treatment for POP is the use of pessaries. Pessaries are removable devices placed inside the vagina that can relieve POP symptoms. Unfortunately, pessaries have fixed sizes and three in ten patients cannot find the right fit. Pessaries can cause bleeding and discomfort if they do not fit well or are not removed and cleaned regularly. Almost half of patients who wear pessaries stop using them because of these issues. There is a need for a better pessary treatment for patients. The investigators have developed a new pessary that has the natural shape of the vagina. This pessary is easier to remove and re-insert. The pessary is also custom fit for each patient. In this study, the investigators will compare our new pessary to traditional pessaries. Study participants who have been fit with a traditional pessary will be asked to use our new pessary design for 3 months. Study participants will fill out questionnaires about their POP symptoms. The investigators will also ask patients to provide their feedback on comfort and how easy it is to use the new pessary. This study could open up new possibilities for treating POP across Canada and around the world.

Research Team

Lucas Vasas, MD

Principal Investigator

University of Alberta

Eligibility Criteria

This trial is for Canadian women experiencing Pelvic Organ Prolapse (POP), who have previously been fitted with a traditional pessary. Participants should be willing to switch to the new custom-fit pessary and provide feedback on its use, comfort, and effectiveness in managing POP symptoms over a 3-month period.

Inclusion Criteria

I was assigned female at birth.

I have been using a pessary for my pelvic organ prolapse symptoms for over 3 months.

Fluency in English

Exclusion Criteria

I have vaginal damage from using a pessary.

I have inflammatory bowel disease.

I was born with a malformation of my bladder, rectum, or vagina.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Standard Pessary Use

Participants use a standard pessary for baseline comparison

4 weeks

1 visit (in-person)

Treatment with Novel Personalizable Pessary

Participants use the novel personalizable pessary and provide feedback on comfort and ease of use

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Personalizable Pessary

Trial Overview The study is testing a novel personalizable pessary designed to match the natural shape of the vagina, aiming to improve fit and ease of use compared to traditional fixed-size pessaries. The trial involves using this new device for three months while monitoring symptom relief and overall satisfaction.

Participant Groups

Group I: Novel Personalizable Pessary Arm Experimental Treatment 1 Intervention

All patients in the study have previously been fit and used a standard pessary prior to the trial. They will use their standard pessary for one month. All participants will then be fit with a novel pessary, which they will use for 3 months.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Cosm Medical

Collaborator

Alberta Innovates Health Solutions

Collaborator

Trials

54

Recruited

94,100+

Findings from Research

A custom-made pessary, created using a 3D printer and medical-grade silicone, was successfully used in a patient with stress urinary incontinence (SUI) who had previously failed commercial pessary fittings.

The patient experienced no discomfort or leakage during a 48-hour trial, indicating that 3D-printed pessaries can provide a comfortable and effective alternative for women with unique anatomical needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Customized Pessary Fabrication Using Three-Dimensional Printing Technology. Barsky, M., Kelley, R., Bhora, FY., et al.[2021]

Flexible silicone vaginal support pessaries are a low-risk and effective treatment option for managing symptoms of pelvic organ prolapse.

The article provides clinical recommendations and evidence regarding the indications for use, selection of pessaries, and proper fitting techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaginal support pessaries: indications for use and fitting strategies. Atnip, S., O'Dell, K.[2013]

References

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

Vaginal pessary continuation in symptomatic pelvic organ prolapse patients with prior hysterectomy. [2021]

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

Factors associated with pessary fitting in women with symptomatic pelvic organ prolapse: A large prospective cohort study. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Predictors for unsuccessful pessary fitting in women with symptomatic pelvic organ prolapse: a prospective study. [2022]

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

Which factors should be considered in choosing pessary type and size for pelvic organ prolapse patients in a fitting trial? [2018]

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

Parameters associated with unsuccessful pessary fitting for pelvic organ prolapse up to three months follow-up: a systematic review and meta-analysis. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Ring pessary for all pelvic organ prolapse. [2011]

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

Effect of vaginal pessaries on symptoms associated with pelvic organ prolapse. [2019]

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

Clinical characteristics associated with unsuccessful pessary fitting outcomes. [2013]

9. Ireland pubmed.ncbi.nlm.nih.gov

Predictors for dislodgment of vaginal pessary within one year in women with pelvic organ prolapse. [2018]

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

Customized Pessary Fabrication Using Three-Dimensional Printing Technology. [2021]

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

Vaginal support pessaries: indications for use and fitting strategies. [2013]