Efficacy/Safety of Urogynecology Synthetic Mesh Surgery

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

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age30-100

SponsorMackay Medical College

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pelvic organ prolapse patients with objective / subjective voiding dysfunctions

Underwent surgery for symptomatic POP ≥ stage II (POP-Q system)

Disqualifiers

Patients with a history of pelvic radiation.

Patients with a history of vesico-/recto-/urethra-vaginal fistula

Patients unable to be followed up.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

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

Treatment groups

150 Participants

are divided into 3 treatment groups

Group A: mesh surgery1 intervention

Group B: Robotic-assisted sacrocolpopexy1 intervention

Group C: a hysterectomy with trans-vaginal mesh repair (Surelift®, Neomedic International, Barcelona, Spain)1 intervention

Trial outcomes

Primary outcomes

trans-vaginal mesh repair

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.

Time frame

Generally in our hospital, pre-operative investigation will be done about 30 days before surgery, post-operative investigation will within 1year after surgery.

Sponsors and contacts

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Mackay Medical College

Lead sponsor

Source ClinicalTrials.gov

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