Efficacy/Safety of Urogynecology Synthetic Mesh Surgery

RecruitingOBSERVATIONAL
Enrollment

150

Participants

Timeline

Start Date

August 1, 2022

Primary Completion Date

August 1, 2023

Study Completion Date

December 31, 2027

Conditions
Pelvic Organ ProlapseStage III and IV High Grade Pelvic Organ Prolapse
Interventions
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.

Trial Locations (1)

Unknown

RECRUITING

Department of Obstetrics and Gynecology, New Taipei City

Sponsors
All Listed Sponsors
lead

Mackay Medical College

OTHER