Clinical trial NCT05682989: Efficacy/Safety of Urogynecology Synthetic Mesh Surgery
Official title: Evaluation of Efficacy and Safety of Urogynecology Synthetic Mesh Surgery in Women With Pelvic Organ Prolapse
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pelvic Organ Prolapse
Stage III and IV High Grade Pelvic Organ Prolapse
Lead sponsor: Mackay Medical College
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 150
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: History of POP patients with concurrent objective and/or subjective voiding dysfunctions who underwent primary TVM surgery for symptomatic POP

≥ stage II (POP Quantification system; POP-Q system) in Mackay Memorial Hospital were recruited.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: trans-vaginal mesh repair
timeFrame: Generally in our hospital, pre-operative investigation will be done about 30 days before surgery, post-operative investigation will within 1year after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Department of Obstetrics and Gynecology
Study officials:
affiliation: Department of Ear, Nose, and Throat, MacKay Memorial Hospital, Taipei, Taiwan
name: Hui-Hsuan Lau, M.D.
role: STUDY_CHAIR
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