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Active, Not Recruiting

NCT Number: NCT05760794

Barbed-suture Efficiency Study for Sacrocolpopexy

Minimally invasive sacrocolpopexy (SCP) performed laparoscopically or with robotic assistance is associated with improved patient-centered outcomes such as faster recovery times, less pain, less bleeding, and shorter hospital stay, however at the expense of longer operating times. One of the time consuming parts of the procedure is vaginal mesh attachment.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Prolapse; Female Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse

Age range

21 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

The purpose of this research study is to compare two different suture types that are used to attach vaginal mesh that is typically used in women undergoing robotic or laparoscopic sacrocolpopexy (attachment of the vagina to the sacral promontory). The barbed suture is one continuous suture, while the delayed absorbable suture involves placing individual sutures and tying a knot for each. All women will have permanent sutures that attach the mesh to the sacral promontory, which is standard of care. The goal is to determine if the barbed delayed absorbable suture decreases the time of vaginal mesh attachment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-barbed delayed absorbable suture

Procedure

The non-barbed delayed absorbable suture group vaginal mesh attachment will be performed with 2-0 PDS (polydioxanone). The vaginal mesh will be attached with at least four interrupted sutures on the anterior vagina and posterior vagina.

Barbed delayed absorbable suture

Procedure

The barbed delayed absorbable suture group vaginal mesh attachment will be performed with 2-0 V-Loc. The vaginal mesh will be attached with a running V-Loc on the anterior and posterior vagina.

Primary outcomes

  1. Time to complete vaginal graft attachment

    Time frame: Day 1

    To determine if delayed-absorbable barbed suture (2-0 V-Loc) produces a decrease in the time to achieve vaginal mesh attachment during minimally invasive SCP (with or without concomitant total hysterectomy) compared to delayed- absorbable polydioxanone (2-0 PDS) interrupted suture - time (in minutes and seconds)

Secondary outcomes

  1. Composite success rate

    Time frame: Year 1

    To compare the 1-year composite success rates of minimally invasive sacrocolpopexy (SCP) between the two groups:

    • Anatomic success: leading edge of prolapse is at or above the hymen (POP-Q point Ba and Bp less than or equal to and vaginal apex less than 1/3 of the total vaginal length
    • Subjective success: patient denies symptoms of vaginal bulging per Pelvic Floor Distress Inventory (PFDI)-20 question 3, answering "No" or "Yes" but "Not at all" bothersome
    • Assessment for re-intervention or re-operation for recurrence or persistence of pelvic organ prolapse: No need for pessary use or additional surgical treatment for prolapse at any time after the initial procedure

  2. Vaginal mesh exposure at 1 year

    Time frame: Year 1

    To compare the 1 year rate of vaginal mesh exposure between the two groups - Signs and symptoms of mesh exposure include vaginal or pelvic pain, vaginal discharge or bleeding, odor, recurrent infection, abscess development, dyspareunia, or pain experienced by the sexual partner. Pain is the most common presenting symptom.

  3. Adverse outcome scores

    Time frame: Week 6

    To compare adverse outcomes, classified according to the Clavien-Dindo system, between the two groups - It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V) - the higher the grade; the worse the complication

  4. Surgeon satisfaction with technique

    Time frame: Day 1

    To compare intraoperative surgeon satisfaction with technique between the two groups - satisfaction with technique will be assessed with a 10 point visual analog scale (VAS) for ease of placement, appearance of mesh attachment, and global satisfaction with the attachment type - 0 meaning difficult and 10 meaning easy

  5. Patient change in quality of life, symptom bother, and sexual functioning - (PFDI-20) Pelvic Floor Distress Inventory

    Time frame: Year 1

    Assessment of participant changes in quality of life, symptom bother, and sexual functioning at 1 year compared to baseline - The total PFDI-20 score was classified as the absence of symptoms (score zero), symptoms with mild distress (1 to 15 points), symptoms with moderate distress (16 to 34 points), and symptoms with severe distress (35 to 40 points)

  6. Patient change in quality of life, symptom bother, and sexual functioning - (PISQ-sf) Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form

    Time frame: Year 1

    Assessment of participant changes in quality of life, symptom bother, and sexual functioning at 1 year compared to baseline - a validated general questionnaire widely used in clinical practice as a screening tool for female sexual dysfunction, as well as in clinical trials as an outcome measure. It consists of 19 items, grouped into six domains: Desire, Arousal, Lubrication, Orgasm, Satisfaction, and Pain. The total score is obtained by adding the six domain scores (range: 2.0-36.0). Higher scores in particular domains and total score indicate better sexual function.

  7. Patient change in quality of life, symptom bother, and sexual functioning - (PFIQ-sf7) Pelvic Floor Impact Questionnaire Short form

    Time frame: Year 1

    Assessment of participant changes in quality of life, symptom bother, and sexual functioning at 1 year compared to baseline - scores range from 0-300. A lower score means there is a lesser effect on quality of life.

Other outcomes

  1. Mesh related adverse events and surgical success compared to PACT trial

    Time frame: Year 1

    To compare mesh-related adverse events (mesh exposure, pain) and surgical success within the first post-operative year in the BEST trial compared to historical data collected in the PACT trial.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

BEST: Barbed-suture Efficiency Study for Sacrocolpopexy

Acronym: BEST

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 8, 2023
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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