Prolapse; FemaleBESTNCT05760794
Barbed-suture Efficiency Study for Sacrocolpopexy
A study testing Non-barbed delayed absorbable suture and Barbed delayed absorbable suture in people with Prolapse; Female, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years, women only
- Conditions the study is for
- Prolapse; Female
- What is being tested?
- Non-barbed delayed absorbable suture and Barbed delayed absorbable suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: BEST: 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.
Read the detailed description
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.
- Conditions
- Prolapse; Female
- Being tested
- Non-barbed delayed absorbable suture, Barbed delayed absorbable suture
- Keywords
- sacrocolpopexy, pelvic organ prolapse, vaginal mesh attachment
- Medical subject headings
- Prolapse, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-barbed delayed absorbable sutureProcedure or surgery
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 sutureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Barbed delayed absorbable suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 1
Secondary outcomes (7)
Composite success rate
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
Measured: Year 1
Vaginal mesh exposure at 1 year
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.
Measured: Year 1
Adverse outcome scores
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
Measured: Week 6
Surgeon satisfaction with technique
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
Measured: Day 1
Patient change in quality of life, symptom bother, and sexual functioning - (PFDI-20) Pelvic Floor Distress Inventory
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)
Measured: Year 1
Patient change in quality of life, symptom bother, and sexual functioning - (PISQ-sf) Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form
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.
Measured: Year 1
Patient change in quality of life, symptom bother, and sexual functioning - (PFIQ-sf7) Pelvic Floor Impact Questionnaire Short form
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.
Measured: Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start21 Jun 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Prolapse; FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine L Woodburn, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760794
- Sponsor's protocol ID
- IRB00093867
- Acronym
- BEST
- Status last verified
- Dec 2025
- First submitted
- 25 Feb 2023
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23633316Siddiqui 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.
PubMed 25560102Paraiso 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.
PubMed 15902189Geller 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.
PubMed 19037026Matthews 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.
PubMed 32649494Bazzi 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.
PubMed 30807409Moore 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.
PubMed 27766346Catanzarite 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.
PubMed 26070725Childers 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.
PubMed 29490366Crane 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.
PubMed 23640003Tan-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.
PubMed 25421934Lowman 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.
PubMed 18377864Cundiff 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.
PubMed 18976976Tan-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.
PubMed 20842494Gabra 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). 2026 Aug 1;32(8):996-1004. doi: 10.1097/SPV.0000000000001768.
PubMed 41252163
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BEST: Barbed-suture Efficiency Study for Sacrocolpopexy
- ClinicalTrials.gov ID
- NCT05760794
- Acronym / sponsor ID
- BEST / IRB00093867
- Conditions
- Prolapse; Female
- Keywords
- sacrocolpopexy, pelvic organ prolapse, vaginal mesh attachment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Non-barbed delayed absorbable suture | Experimental | Procedure: Non-barbed delayed absorbable sutureParticipants assigned to Non-barbed delayed absorbable suture group will have Non-barbed delayed absorbable suture used for vaginal mesh attachment at time of SCP |
| Barbed delayed absorbable suture | Experimental | Procedure: Barbed delayed absorbable sutureParticipants assigned to Barbed delayed absorbable suture group will have Barbed delayed absorbable suture used for vaginal mesh attachment at time of SCP |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-barbed delayed absorbable sutureThe 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. | Procedure or surgery | Non-barbed delayed absorbable suture |
| Barbed delayed absorbable sutureThe 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. | Procedure or surgery | Barbed delayed absorbable suture |
Primary outcome
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)
7 secondary outcomes
Composite success rate
Time frame: Year 1
Vaginal mesh exposure at 1 year
Time frame: Year 1
Adverse outcome scores
Time frame: Week 6
Surgeon satisfaction with technique
Time frame: Day 1
Patient change in quality of life, symptom bother, and sexual functioning - (PFDI-20) Pelvic Floor Distress Inventory
Time frame: Year 1
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
Patient change in quality of life, symptom bother, and sexual functioning - (PFIQ-sf7) Pelvic Floor Impact Questionnaire Short form
Time frame: Year 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Background: PubMed 23633316Maher 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.
- Background: PubMed 25560102Siddiqui 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.
- Background: PubMed 15902189Paraiso 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.
- Background: PubMed 19037026Geller 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.
- Background: PubMed 32649494Matthews 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.
- Background: PubMed 30807409Bazzi 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.
- Background: PubMed 27766346Moore 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.
- Background: PubMed 26070725Catanzarite 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.
- Background: PubMed 29490366Childers 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.
- Background: PubMed 23640003Crane 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.
- Background: PubMed 25421934Tan-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.
- Background: PubMed 18377864Lowman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine L Woodburn, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-barbed delayed absorbable suture and Barbed delayed absorbable suture in people with Prolapse; Female, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete vaginal graft attachment (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05760794, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.