Barbed Sutures for Uterine Prolapse

(BEST Trial)

Overseen By Sachin Vyas, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must not be taking: Systemic steroids, Immunosuppressives

Disqualifiers: Pelvic organ cancer, Systemic infection, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Day 1

52 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking systemic steroids, immunosuppressive, or immunomodulatory treatments, you may not be eligible if taken recently. Please consult with the trial coordinators for more details.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking systemic steroids or immunosuppressive treatments, you may not be eligible to participate.

What data supports the idea that Barbed Sutures for Uterine Prolapse is an effective treatment?

The available research shows that using barbed sutures for uterine prolapse, specifically in robotic sacrocolpopexy, leads to positive outcomes. One study found that after one year, patients who had this treatment experienced improvements in their condition. Another study compared barbed sutures to non-barbed sutures and found that barbed sutures were effective in securing mesh without increasing the risk of failure. Additionally, barbed sutures resulted in fewer complications, like suture erosion, compared to nonabsorbable sutures. This suggests that barbed sutures are a reliable option for treating uterine prolapse. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Barbed Sutures for Uterine Prolapse?

Research on robotic sacrocolpopexy (a surgical procedure for pelvic organ prolapse) using barbed delayed absorbable sutures shows positive outcomes, suggesting that these sutures can be effective in similar procedures like uterine prolapse repair. ^{1 2 3 4 5}

What safety data exists for barbed sutures in uterine prolapse treatment?

The safety data for barbed sutures in uterine prolapse treatment includes studies on robotic sacrocolpopexy (RSC) using barbed delayed absorbable sutures, which evaluated 1-year outcomes. Another study compared the use of delayed absorbable sutures with nonabsorbable ones in robotic sacral colpopexy (RASC), finding that delayed absorbable sutures did not increase the risk of prolapse recurrence and reduced the need for postoperative suture excision. Additionally, a randomized trial compared barbed and non-barbed delayed absorbable sutures for mesh attachment in sacrocolpopexy, providing insights into their efficiency and efficacy. ^{1 2 3 4 6}

Is it safe to use barbed delayed absorbable sutures in humans?

Research shows that using barbed delayed absorbable sutures in surgeries like sacrocolpopexy (a procedure to correct pelvic organ prolapse) is generally safe. There were fewer complications like suture erosion (when the suture becomes exposed) compared to non-absorbable sutures, and no need for suture removal was reported in the delayed absorbable group. ^{1 2 3 4 6}

Is the treatment Barbed delayed absorbable suture a promising treatment for uterine prolapse?

Yes, barbed delayed absorbable sutures, like V-Loc and Quill, show promise as they are effective, efficient, and may reduce complications compared to traditional sutures in similar procedures. ^{4 7 8 9 10}

How is the barbed delayed absorbable suture treatment for uterine prolapse different from other treatments?

The barbed delayed absorbable suture, like V-Loc™ and Quill™, is unique because it doesn't require knots, which can make the suturing process faster and potentially reduce complications compared to traditional sutures that need knots. ^{4 7 8 9 10}

Research Team

Katherine L Woodburn, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for English-speaking women over 21 with bothersome vaginal bulge, eligible for laparoscopic or robotic sacrocolpopexy due to uterine prolapse. They must not have poorly controlled diabetes, be unable to maintain certain positions during surgery, or have medical conditions preventing surgery. Women who've had prior mesh repairs or pelvic organ cancer, those on recent steroids/immunosuppressants, and with sensitivity to polypropylene are excluded.

Inclusion Criteria

I want surgery for my prolapse symptoms.

I have a prolapse that extends to or beyond the vaginal opening.

Subject reports a bothersome bulge they can see or feel per Pelvic Floor Disability Index (PFDI-20), question 3, response of 2 or higher

Exclusion Criteria

I am unable to understand or participate in the study procedures.

I do not have any active infections, including UTIs or tissue necrosis.

I need surgery to fix a rectal prolapse.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo minimally invasive sacrocolpopexy with either barbed or non-barbed delayed absorbable sutures for vaginal mesh attachment

Day 1

1 visit (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and adverse outcomes, including mesh exposure and quality of life changes

1 year

Multiple visits (in-person and virtual)

Adverse Outcome Monitoring

Adverse outcomes are assessed and classified according to the Clavien-Dindo system

6 weeks

Treatment Details

Interventions

• Barbed delayed absorbable suture
• Non-barbed delayed absorbable suture

Trial Overview The study compares two types of sutures used in minimally invasive sacrocolpopexy: non-barbed delayed absorbable suture versus barbed delayed absorbable suture. The goal is to see if one results in faster operation times without compromising patient outcomes like recovery speed and hospital stay duration.

Participant Groups

Group I: Non-barbed delayed absorbable suture Experimental Treatment 1 Intervention

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

Group II: Barbed delayed absorbable suture Experimental Treatment 1 Intervention

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

Barbed delayed absorbable suture is already approved in United States, European Union for the following indications:

Approved in United States as Barbed delayed absorbable suture for:

• Sacrocolpopexy
• Vaginal mesh attachment

Approved in European Union as Barbed delayed absorbable suture for:

• Sacrocolpopexy
• Vaginal mesh attachment

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Findings from Research

In a study of 57 subjects who underwent uterosacral ligament suspension (USLS) with delayed absorbable polyglyconate suture, only 3.5% experienced suture complications, indicating a high safety profile for this suture type.

The anatomic and symptomatic failure rate was low at 7%, significantly lower than the 44.6% suture erosion rate seen with permanent sutures in previous studies, suggesting that polyglyconate suture is an effective option for this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uterosacral ligament vaginal vault suspension using delayed absorbable monofilament suture. Wong, MJ., Rezvan, A., Bhatia, NN., et al.[2021]

In a study of 20 patients undergoing robotic sacrocolpopexy (RSC) with barbed delayed absorbable sutures, there were no recurrences of apical defects or mesh-related complications after 1 year, indicating the procedure's safety and efficacy.

While the majority of patients had successful outcomes, a few experienced complications, including a grade 2 cystocele and new-onset urinary incontinence, suggesting that while the technique is effective, further research is needed to assess long-term outcomes and risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of robotic sacrocolpopexy using barbed delayed absorbable sutures. Borahay, MA., Oge, T., Walsh, TM., et al.[2022]

In a study of 119 women undergoing robot-assisted sacral colpopexy, using delayed absorbable sutures for mesh fixation resulted in significantly fewer suture erosions compared to traditional nonabsorbable sutures, with only 2 erosions noted in the absorbable group versus 9 in the nonabsorbable group.

The use of delayed absorbable sutures did not increase the risk of surgical failure, as apical and posterior compartment failures were similar between the two suture types, suggesting that this alternative suture may improve postoperative outcomes without compromising effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Securing Mesh with Delayed Absorbable Suture Does Not Increase Risk of Prolapse Recurrence After Robotic Sacral Colpopexy. Powell, CR., Tachibana, I., Eckrich, B., et al.[2021]

The use of barbed sutures for vaginal mesh attachment during laparoscopic and robotic sacrocolpopexy was significantly faster, taking about 29 minutes compared to 42 minutes for non-barbed sutures, indicating greater efficiency in the surgical procedure.

Despite the faster attachment time with barbed sutures, both suture types showed comparable anatomic outcomes at 12 months, suggesting that the choice of suture may not impact long-term effectiveness in preventing pelvic organ prolapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of vaginal mesh attachment techniques for minimally invasive sacrocolpopexy. Tan-Kim, J., Nager, CW., Grimes, CL., et al.[2022]

A new surgical technique for treating female stress urinary incontinence involves placing two double monofilament sutures in a spiral pattern on the vaginal walls, which are then secured to Cooper's ligament.

In a preliminary study of 26 patients, this technique was found to be easy to perform and showed a wide range of applicability, suggesting it could be a promising option for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new colpocystourethropexy for female stress urinary incontinence. Lenzi, R., Barbagli, G., Stomaci, N., et al.[2019]

A review of 8 studies involving 726 subjects found that both autologous fascial slings (AFS) and synthetic slings (SS) are effective in treating female stress urinary incontinence (SUI), with similar success rates in both short- and long-term follow-ups.

While AFS has comparable effectiveness to SS, it requires longer operative times and hospital stays, and is associated with fewer complications like bladder perforation, making it a safer alternative as concerns about synthetic materials grow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resurgence of Autologous Fascial Slings in a Challenging Climate for Sling Surgery: A 20-Year Review of Comparative Data. Chen, YA., Jean-Michel, M.[2022]

The use of absorbable barbed wire (V-Loc) sutures during laparoscopic myomectomy significantly reduced operative time (51 minutes) and suturing time (9.9 minutes) compared to traditional continuous sutures (58 minutes and 15.8 minutes, respectively).

Patients in the V-Loc group experienced significantly less intraoperative bleeding and a smaller drop in hemoglobin levels, indicating improved safety and efficacy in surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new type of absorbable barbed suture for use in laparoscopic myomectomy. Angioli, R., Plotti, F., Montera, R., et al.[2016]

In a study of 150 women undergoing laparoscopic sacrocervicopexy, late absorbable sutures were found to be non-inferior to non-absorbable sutures, achieving a 100% success rate in prolapse correction at 12 months.

The use of late absorbable sutures resulted in a lower rate of mesh erosion (0%) compared to non-absorbable sutures (4%), suggesting a potential safety advantage without compromising surgical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of absorbable and permanent sutures for laparoscopic sacrocervicopexy: A randomized controlled trial. Tagliaferri, V., Ruggieri, S., Taccaliti, C., et al.[2023]

In a study of 490 women undergoing total laparoscopic hysterectomy, the V-Loc barbed suture was associated with shorter operative times and less estimated blood loss compared to the Polysorb braided absorbable suture.

The V-Loc suture also resulted in fewer cases of vaginal cuff granulomatous formation six months post-surgery, indicating it may be a safer and more effective option for vaginal cuff closure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

V-Loc™ 180 suture in total laparoscopic hysterectomy: a retrospective study comparing Polysorb to barbed suture used for vaginal cuff closure. Cong, L., Li, C., Wei, B., et al.[2022]

The V-Loc™ 180 Wound Closure Device demonstrated significantly greater biomechanical strength compared to the Quill™ PDO Knotless Tissue-Closure Device in a porcine model, particularly at critical healing timepoints (days 3 and 7).

Both devices showed no major complications or issues such as suture extrusion or tissue distortion, indicating that they are safe for use in skin closures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of V-Loc™ 180 wound closure device and Quill™ PDO knotless tissue-closure device for intradermal closure in a porcine in vivo model: evaluation of biomechanical wound strength. Gingras, K., Zaruby, J., Maul, D.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Uterosacral ligament vaginal vault suspension using delayed absorbable monofilament suture. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Outcomes of robotic sacrocolpopexy using barbed delayed absorbable sutures. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Securing Mesh with Delayed Absorbable Suture Does Not Increase Risk of Prolapse Recurrence After Robotic Sacral Colpopexy. [2021]

4. England pubmed.ncbi.nlm.nih.gov

A randomized trial of vaginal mesh attachment techniques for minimally invasive sacrocolpopexy. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A new colpocystourethropexy for female stress urinary incontinence. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Resurgence of Autologous Fascial Slings in a Challenging Climate for Sling Surgery: A 20-Year Review of Comparative Data. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A new type of absorbable barbed suture for use in laparoscopic myomectomy. [2016]

8. United States pubmed.ncbi.nlm.nih.gov

Comparison of absorbable and permanent sutures for laparoscopic sacrocervicopexy: A randomized controlled trial. [2023]

9. Ireland pubmed.ncbi.nlm.nih.gov

V-Loc™ 180 suture in total laparoscopic hysterectomy: a retrospective study comparing Polysorb to barbed suture used for vaginal cuff closure. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Comparison of V-Loc™ 180 wound closure device and Quill™ PDO knotless tissue-closure device for intradermal closure in a porcine in vivo model: evaluation of biomechanical wound strength. [2020]