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New stitch could cut surgery time for pelvic organ prolapse

NCT ID NCT05760794

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two types of stitches used during minimally invasive surgery for pelvic organ prolapse in women. The goal is to see if barbed sutures (which hold tissue without knots) can attach the vaginal mesh faster than traditional interrupted sutures. Fifty-two women will be randomly assigned to one of the two suture types, and the time to complete mesh attachment will be measured. The study also checks if the surgery is still successful after one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
barbed delayed absorbable suture (2-0 V-Loc)
What this could lead to
If barbed sutures work faster, this could shorten surgery time for women with pelvic organ prolapse, potentially reducing risks from longer anesthesia.
What could go wrong
This is a small, early-stage study with only 52 participants, so results may not apply to everyone. The barbed suture might not save much time or could have different long-term success rates.

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 52 people

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

Started

Jun 2023

Expected to finish

Dec 2027

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

21 to 80 years

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: * Age ≥21 * Subject must have apical with anterior or posterior vaginal prolapse with leading edge of prolapse to or beyond the hymen * Subject reports a bothersome bulge they can see or feel per Pelvic Floor Disability Index (PFDI-20), question 3, response of 2 or higher * Eligible for laparoscopic or robotic sacrocolpopexy * Desires surgical treatment for symptomatic uterovaginal or vaginal vault prolapse * English speaking Exclusion Criteria: * Patients who are not surgical candidates due to medical comorbidities * Current foreign body complications (including but not limited to erosion, fistula, abscess). This covers foreign bodies of any type (e.g. synthetic and biologic including allograft, xenograft). * Inability to give informed consent or to complete the testing or data collection. * Anticipated circumstances resulting in an inability to follow up (geographic relocation, etc.). * Active systemic infection including any gynecologic infection, untreated Urinary Tract Infection (UTI) or tissue necrosis. * History of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical). * Prior or currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area. * Subject has taken systemic steroids (within the last month, steroid inhalers OK), or immunosuppressive or immunomodulatory treatment (within the last 3 months) * Systemic connective tissue disease (e.g. scleroderma, Marfan's syndrome, Ehlers Danhlos, collagenosis, polymyositis or polymyalgia rheumatic, lupus) * Chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis * Poorly controlled diabetes mellitus (DM), as indicated by Hemoglobin A1c \> 9 * Those requiring concomitant rectopexy * Subject is not able to conform to steep Trendelenburg position * Known sensitivity to polypropylene * History of prior prolapse repair utilizing vaginal or abdominal mesh * Planned vaginal mesh attachment placed transvaginally * History of diverticulitis

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157, United States

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