Efficacy/Safety of Urogynecology Synthetic Mesh Surgery

Mackay Medical College

Status: Enrolling

Conditions: Stage III and IV High Grade Pelvic Organ Prolapse; Pelvic Organ Prolapse

Treatments: Procedure: Urodynamic investigations before and after a robotic-assisted sacrocolpopexy protocol.; Procedure: Urodynamic investigations before and after a mesh surgery protocol.; Procedure: Urodynamic investigations before and after a hysterectomy with trans-vaginal mesh repair

Study type: Observational

Funder types: Other

Identifiers

NCT05682989

22MMHIS361e

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 30 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pelvic organ prolapse patients with objective / subjective voiding dysfunctions
• Underwent surgery for symptomatic POP ≥ stage II (POP-Q system)

Exclusion criteria

• Patients with a history of pelvic radiation.
• Patients with a history of vesico-/recto-/urethra-vaginal fistula
• Patients unable to be followed up.

Trial design

150 participants in 3 patient groups

mesh surgery

Description:

Data obtained before the operation

Treatment:

Procedure: Urodynamic investigations before and after a mesh surgery protocol.

Robotic-assisted sacrocolpopexy

Description:

Data obtained before the operation

Treatment:

Procedure: Urodynamic investigations before and after a robotic-assisted sacrocolpopexy protocol.

a hysterectomy with trans-vaginal mesh repair (Surelift®, Neomedic International, Barcelona, Spain)

Description:

Data obtained before the operation

Treatment:

Procedure: Urodynamic investigations before and after a hysterectomy with trans-vaginal mesh repair