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Mesh vs sutures: which surgery works best for pelvic organ prolapse?

NCT ID NCT02965313

Disease control Sponsor: University of British Columbia Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two types of vaginal surgery for pelvic organ prolapse (when organs like the bladder or uterus drop into the vagina). One method uses a synthetic mesh, the other uses standard sutures. About 358 women will be randomly assigned to one of the two surgeries and followed for 2 years to see which approach is more successful and durable. The goal is to improve surgical outcomes and reduce the need for repeat treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 358 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Nov 2016

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Women over 19 years of age 2. Able to read and write in English 3. Able to follow up with clinic visits for up to two years after surgery 4. Diagnosed with bothersome pelvic organ prolapse including at the top of the vagina Exclusion Criteria: 1. Women who wish to conserve the uterus 2. Prior pelvic radiation 3. Prior vaginal mesh surgery for prolapse 4. Prior vaginal mesh exposure 5. Presence of vaginal pain from pelvic floor muscle spasm documented at baseline visit 6. Plan for synthetic vaginal mesh insertion for prolapse, at the same time, at locations other than the top of the vagina (NOTE: concurrent need for synthetic anti-incontinence sling is NOT an exclusion) 7. Immune compromise; chronic steroid use 8. Current smoker 9. Currently pregnant or breastfeeding 10. Presence of pain syndromes likely to cause a heightened sensitivity to pelvic pain (IE fibromyalgia or painful bladder syndrome)

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Conditions

The condition(s) this trial relates to.

pelvic organ prolapse

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pelvic organ prolapse

Contacts and locations

Locations

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 2K5, Canada

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