New stitch could cut surgery time for pelvic organ prolapse
NCT ID NCT05760794
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
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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
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About 52 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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21 to 80 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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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Genom att skicka in godkänner du våra Användarvillkor
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
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
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