Barbed-suture Efficiency Study for Sacrocolpopexy

NCT05760794 | Active Not Recruiting

• 1 other identifier: IRB00093867
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prolapse; Female

Keywords

sacrocolpopexy; pelvic organ prolapse; vaginal mesh attachment

Outcome Measures

Primary Outcomes (1)

• Time to complete vaginal graft attachment

  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)

  Day 1

Secondary Outcomes (7)

• Composite success rate

  Year 1

• Vaginal mesh exposure at 1 year

  Year 1

• Adverse outcome scores

  Week 6

• Surgeon satisfaction with technique

  Day 1

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

  Year 1

Other Outcomes (1)

• Mesh related adverse events and surgical success compared to PACT trial

  Year 1

Study Arms (2)

Non-barbed delayed absorbable suture

EXPERIMENTAL

Participants assigned to Non-barbed delayed absorbable suture group will have Non-barbed delayed absorbable suture used for vaginal mesh attachment at time of SCP

Procedure: Non-barbed delayed absorbable suture

Barbed delayed absorbable suture

EXPERIMENTAL

Participants assigned to Barbed delayed absorbable suture group will have Barbed delayed absorbable suture used for vaginal mesh attachment at time of SCP

Procedure: Barbed delayed absorbable suture

Interventions

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.

Non-barbed delayed absorbable suture

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.

Barbed delayed absorbable suture

Eligibility Criteria

• Age: 21 Years - 80 Years
• Gender Eligibility Details: women with symptomatic uterovaginal or vaginal vault prolapse, without a prior history of mesh repair, who have completed childbearing, are seeking surgical management, and are willing to proceed with abdominal placement of permanent synthetic mesh.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (15)

• Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2013 Apr 30;(4):CD004014. doi: 10.1002/14651858.CD004014.pub5.

  PMID: 23633316 BACKGROUND

• Siddiqui NY, Grimes CL, Casiano ER, Abed HT, Jeppson PC, Olivera CK, Sanses TV, Steinberg AC, South MM, Balk EM, Sung VW; Society of Gynecologic Surgeons Systematic Review Group. Mesh sacrocolpopexy compared with native tissue vaginal repair: a systematic review and meta-analysis. Obstet Gynecol. 2015 Jan;125(1):44-55. doi: 10.1097/AOG.0000000000000570.

  PMID: 25560102 BACKGROUND

• Paraiso MF, Walters MD, Rackley RR, Melek S, Hugney C. Laparoscopic and abdominal sacral colpopexies: a comparative cohort study. Am J Obstet Gynecol. 2005 May;192(5):1752-8. doi: 10.1016/j.ajog.2004.11.051.

  PMID: 15902189 BACKGROUND

• Geller EJ, Siddiqui NY, Wu JM, Visco AG. Short-term outcomes of robotic sacrocolpopexy compared with abdominal sacrocolpopexy. Obstet Gynecol. 2008 Dec;112(6):1201-1206. doi: 10.1097/AOG.0b013e31818ce394.

  PMID: 19037026 BACKGROUND

• Matthews CA, Geller EJ, Henley BR, Kenton K, Myers EM, Dieter AA, Parnell B, Lewicky-Gaupp C, Mueller MG, Wu JM. Permanent Compared With Absorbable Suture for Vaginal Mesh Fixation During Total Hysterectomy and Sacrocolpopexy: A Randomized Controlled Trial. Obstet Gynecol. 2020 Aug;136(2):355-364. doi: 10.1097/AOG.0000000000003884.

  PMID: 32649494 BACKGROUND

• Bazzi AA, Osmundsen BC, Hagglund KH, Aslam MF. Anatomical Outcomes Based on Suturing Technique During Vaginal Mesh Attachment in Robotic Sacrocolpopexy. Female Pelvic Med Reconstr Surg. 2019 Mar/Apr;25(2):105-108. doi: 10.1097/SPV.0000000000000654.

  PMID: 30807409 BACKGROUND

• Moore R, Moriarty C, Chinthakanan O, Miklos J. Laparoscopic sacrocolpopexy: operative times and efficiency in a high-volume female pelvic medicine and laparoscopic surgery practice. Int Urogynecol J. 2017 Jun;28(6):887-892. doi: 10.1007/s00192-016-3179-1. Epub 2016 Oct 20.

  PMID: 27766346 BACKGROUND

• Catanzarite T, Saha S, Pilecki MA, Kim JY, Milad MP. Longer Operative Time During Benign Laparoscopic and Robotic Hysterectomy Is Associated With Increased 30-Day Perioperative Complications. J Minim Invasive Gynecol. 2015 Sep-Oct;22(6):1049-58. doi: 10.1016/j.jmig.2015.05.022. Epub 2015 Jun 10.

  PMID: 26070725 BACKGROUND

• Childers CP, Maggard-Gibbons M. Understanding Costs of Care in the Operating Room. JAMA Surg. 2018 Apr 18;153(4):e176233. doi: 10.1001/jamasurg.2017.6233. Epub 2018 Apr 18.

  PMID: 29490366 BACKGROUND

• Crane AK, Geller EJ, Matthews CA. Trainee performance at robotic console and benchmark operative times. Int Urogynecol J. 2013 Nov;24(11):1893-7. doi: 10.1007/s00192-013-2102-2. Epub 2013 May 3.

  PMID: 23640003 BACKGROUND

• Tan-Kim J, Nager CW, Grimes CL, Luber KM, Lukacz ES, Brown HW, Ferrante KL, Dyer KY, Kirby AC, Menefee SA. A randomized trial of vaginal mesh attachment techniques for minimally invasive sacrocolpopexy. Int Urogynecol J. 2015 May;26(5):649-56. doi: 10.1007/s00192-014-2566-8. Epub 2014 Nov 25.

  PMID: 25421934 BACKGROUND

• Lowman JK, Woodman PJ, Nosti PA, Bump RC, Terry CL, Hale DS. Tobacco use is a risk factor for mesh erosion after abdominal sacral colpoperineopexy. Am J Obstet Gynecol. 2008 May;198(5):561.e1-4. doi: 10.1016/j.ajog.2008.01.048. Epub 2008 Apr 2.

  PMID: 18377864 BACKGROUND

• Cundiff GW, Varner E, Visco AG, Zyczynski HM, Nager CW, Norton PA, Schaffer J, Brown MB, Brubaker L; Pelvic Floor Disorders Network. Risk factors for mesh/suture erosion following sacral colpopexy. Am J Obstet Gynecol. 2008 Dec;199(6):688.e1-5. doi: 10.1016/j.ajog.2008.07.029. Epub 2008 Oct 31.

  PMID: 18976976 BACKGROUND

• Tan-Kim J, Menefee SA, Luber KM, Nager CW, Lukacz ES. Prevalence and risk factors for mesh erosion after laparoscopic-assisted sacrocolpopexy. Int Urogynecol J. 2011 Feb;22(2):205-12. doi: 10.1007/s00192-010-1265-3. Epub 2010 Sep 15.

  PMID: 20842494 BACKGROUND

• Gabra M, Woodburn KL, El Haraki A, Zdroik A, Duong M, Mezes C, Fisher M, Paukner L, Matthews CA. BEST: Barbed-suture Efficiency Study for Sacrocolpopexy: A Randomized Clinical Trial. Urogynecology (Phila). 2025 Nov 12. doi: 10.1097/SPV.0000000000001768. Online ahead of print.

  PMID: 41252163 DERIVED

MeSH Terms

Conditions

Prolapse; Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Katherine L Woodburn, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patient will be masked to their allocation and post-operative examiners will be masked at the 6 week, 6 month, and 12 month visits
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Plan to enroll 52 participants with intention to treat 26 in each group - Participants will be randomized to delayed-absorbable barbed suture (2-0 V-Loc) versus delayed-absorbable interrupted suture (2-0 PDS).

Study Record Dates

• First Submitted: February 25, 2023
• First Posted: March 8, 2023
• Study Start: June 21, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)