Efficacy/Safety of Urogynecology Synthetic Mesh Surgery
- Conditions
- Stage III and IV High Grade Pelvic Organ ProlapsePelvic Organ Prolapse
- Interventions
- Procedure: Urodynamic investigations before and after a hysterectomy with trans-vaginal mesh repairProcedure: Urodynamic investigations before and after a mesh surgery protocol.Procedure: Urodynamic investigations before and after a robotic-assisted sacrocolpopexy protocol.
- Registration Number
- NCT05682989
- Lead Sponsor
- Mackay Medical College
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 150
- Pelvic organ prolapse patients with objective / subjective voiding dysfunctions
- Underwent surgery for symptomatic POP ≥ stage II (POP-Q system)
- Patients with a history of pelvic radiation.
- Patients with a history of vesico-/recto-/urethra-vaginal fistula
- Patients unable to be followed up.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description a hysterectomy with trans-vaginal mesh repair (Surelift®, Neomedic International, Barcelona, Spain) Urodynamic investigations before and after a hysterectomy with trans-vaginal mesh repair Data obtained before the operation mesh surgery Urodynamic investigations before and after a mesh surgery protocol. Data obtained before the operation Robotic-assisted sacrocolpopexy Urodynamic investigations before and after a robotic-assisted sacrocolpopexy protocol. Data obtained before the operation
- Primary Outcome Measures
Name Time Method trans-vaginal mesh repair Generally in our hospital, pre-operative investigation will be done about 30 days before surgery, post-operative investigation will within 1year after surgery. 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.
1. The urodynamic data of POP patient with grade \> or = II, will be retrograde analyzed and and compared.
2. Pressure-associated parameters, such as abdominal pressure (Pabd), detrusor pressure (Pdet) will be measured as centimeter of water column (cmH2O), volume-associated parameters, such as infused volume (Vinf), voided volume (Vvod) and intravesical volume (Vive) will measured as ml. Derived parameter will be expressed as their results of calculation.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Obstetrics and Gynecology
🇨🇳New Taipei City, Taiwan