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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new kind of pessary for women with pelvic organ prolapse (POP), a condition where organs like the bladder and uterus press into the vagina, causing discomfort. The new pessary is custom-fit to each patient's body and designed for easier use compared to traditional pessaries. Participants will use this new design for three months and provide feedback on comfort and usability. The trial seeks women who have used a standard pessary for at least three months to determine if the new design offers better symptom relief. As an unphased trial, it provides participants the chance to contribute to innovative solutions that could enhance the quality of life for many women.

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 prior data suggests that this pessary is safe for use in pelvic organ prolapse treatment?

Research has shown that pessaries, devices that support pelvic organs, are generally safe for women with pelvic organ prolapse (POP). Studies indicate that vaginal pessaries can be effective and safe for many years, with many women using them for over five years.

In studies with different pessary designs, women who managed their own pessaries experienced fewer problems. This finding suggests that ensuring the pessary is easy to use and fits well is crucial for safety and comfort. The new customizable pessary being tested is designed to fit the natural shape of the vagina, making it easier to remove and insert. This design could reduce the discomfort and bleeding sometimes caused by traditional pessaries that do not fit well.

Overall, the customizable pessary aims to improve comfort and reduce problems, which is promising based on current knowledge about pessary use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the personalizable pessary for pelvic organ prolapse because it offers a tailored approach to treatment. Unlike standard pessaries, which come in fixed sizes and shapes, this novel pessary can be customized to fit each patient's unique anatomy, potentially leading to better comfort and effectiveness. This personalized fit aims to improve patient satisfaction and outcomes, making it a promising advancement in managing pelvic organ prolapse.

What evidence suggests that this personalizable pessary is effective for pelvic organ prolapse?

Research has shown that pessaries can effectively improve symptoms of pelvic organ prolapse (POP). In one study, 90% of women noticed a significant improvement in their prolapse symptoms, and urinary symptoms improved in 58–93% of cases. Another study found that 89.9% of users felt better or much better after using a pessary, with most planning to continue its use. This trial will evaluate a novel personalizable pessary, which participants will use after initially using their standard pessary for one month. Custom-fit pessaries, which are easier to handle, may help reduce common problems like discomfort and complications. Pessaries that users can manage themselves have been shown to give users more control, leading to fewer problems and greater confidence. These findings suggest that custom-fit pessaries could be a promising option for those who have issues with traditional pessaries. ^{1 2 5 6 7}

Who Is on the Research Team?

Lucas Vasas, MD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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

I was assigned female at birth.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06954701

Evaluation of a Personalizable Pessary for Pelvic Organ ... While surgery proves effective, POP recurrence rates are up to 70% within 5 years, requiring reoperation and increasing surgical complications to patients and ...

2. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00503-5/fulltext

Clinical effectiveness of vaginal pessary self-management ... Women who self-managed reported less pessary-related complications and greater confidence in managing pessary problems than women who received ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211524007279

Use of vaginal pessary in women with symptomatic pelvic ... The 1-year satisfaction rate of users was high with 89.9 % reporting being improved or very improved, and 85.7 % planning to continue pessary use for 5 years or ...

4. mayoclinic.org mayoclinic.org/medical-professionals/obstetrics-gynecology/news/pessary-use-and-surgery-improve-prolapse-symptoms-yet-patients-favor-surgical-outcomes/mac-20538110

Pessary use and surgery improve prolapse symptoms, yet ... Mayo Clinic investigators found that both pessary use and surgery for pelvic organ prolapse improved symptoms. However, patients deemed the degree of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10810943/

Outcomes of pessary fitting trials for patients with stage IV ... Prolapse symptoms significantly improved in 90% of cases, and urinary symptoms improved in 58–93% of cases from baseline. The number of vaginal ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0378512223004346

Long-term adherence to pessary use in women with pelvic ... Our data indicates vaginal pessary use for pelvic organ prolapse is feasible and safe for all women and that therapy adherence can extend beyond 5 years.

7. ajog.org ajog.org/article/S0002-9378(24)00097-8/fulltext

Effectiveness & safety of a novel, collapsible pessary for ... The primary outcome was change in Pelvic Floor Distress Inventory-20 (PFDI-20) score. Secondary outcome measures included objective assessment of prolapse ...