NCT05682989

Efficacy/Safety of Urogynecology Synthetic Mesh Surgery

Evaluation of Efficacy and Safety of Urogynecology Synthetic Mesh Surgery in Women With Pelvic Organ Prolapse

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Mackay Medical College · Academic / Other
• Sex: Female
• Age: 30 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is a retrospective cohort study, aiming at analyzing the efficacy and safety of mesh surgery in pelvic organ prolapse. The synthetic mesh for pelvic organ prolapse include transvaginal mesh or laparotomy, laparoscope, or robotic-assisted laparoscopic sacrocolpopexy with mesh augmentation. The investigators would like to evaluate the efficacy and safety, such as recurrence rates and complication rates for women who underwent urogynecology mesh surgery.

Detailed description

Gynecologic mesh, including transvaginal mesh and mesh used in abdominal or laparoscopic sacrocolpopexy, has been used for pelvic organ prolapse since its debut in the US in 2005. It provides higher success and satisfaction rate than traditional colporrhaphy, but mesh-related complications, such as pain, mesh exposure and bleeding, have been reported. U.S. Food and Drug Administration issued a Safety Update in 2011 to inform the public that serious complications associated with synthetic mesh for the transvaginal repair of POP were common. Taiwan FDA and associated committees decided that the use of gynecologic mesh should be regulated. Thorough study and evaluation are needed.

Conditions

• Pelvic Organ Prolapse
• Stage III and IV High Grade Pelvic Organ Prolapse

Interventions

Type	Name	Description
PROCEDURE	Urodynamic investigations before and after a mesh surgery protocol.	Urodynamic investigations (The urodynamic study included free uroflowmetry, postvoid residual, filling and voiding cystometry, and a urethral pressure profile. The filling cystometry and urethral pressure profile were performed with 37 degrees C normal saline similar to body temperature at an infusion rate of 80 ml/min.
PROCEDURE	Urodynamic investigations before and after a robotic-assisted sacrocolpopexy protocol.	All surgeries were performed using a DaVinci robotic system (Intuitive® Surgical Inc., Sunnyvale, California,US) with standardized technique and materials. Patients were positioned in dorsal lithotomy and steep Trendelenburg position. Trocars were placed bilaterally, and an assistant port was placed laterally. The peritoneum was opened medial to the ureter to develop an avascular space. The mesh was placed on the posterior and anterior vaginal wall and fixed at the level of anterior longitudinal ligaments S1/S2 by sutures. An intraoperative clinical examination was performed to ensure the mesh was in a tension-free position.
PROCEDURE	Urodynamic investigations before and after a hysterectomy with trans-vaginal mesh repair	In summary, a vertical incision was made in the anterior vaginal wall to access the vesicovaginal space. The sacrospinous ligament was dissected, and an applicator was inserted and positioned over the SSL. The anchor was fixed to the SSL and the thread was attached to the mesh. The mesh was then adjusted in a tension-free manner, excess mesh was cut, and the incision was closed with suture.

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-08-01
• Completion: 2027-12-31
• First posted: 2023-01-12
• Last updated: 2023-04-05

Locations

1 site across 1 country: Taiwan