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NCT Number: NCT05682989

Efficacy/Safety of Urogynecology Synthetic Mesh Surgery

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.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse Stage III and IV High Grade Pelvic Organ Prolapse

Age range

30 year–100 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Obstetrics and Gynecology

New Taipei City, Taiwan

Location status: Recruiting

Location contact

Hui-Hsuan Lau, PhD

CONTACT

[email protected]

+886 975-835928

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Urodynamic investigations before and after a mesh surgery protocol.

Procedure

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

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

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.

Primary outcomes

  1. trans-vaginal mesh repair

    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.

    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.

    • The urodynamic data of POP patient with grade > or = II, will be retrograde analyzed and and compared.
    • 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hui-Hsuan Lau, M.D.

CONTACT

[email protected]

+886-975-835928

Sponsors and collaborators

Lead sponsor

Mackay Medical College

Other

Registry information

Official study title

Evaluation of Efficacy and Safety of Urogynecology Synthetic Mesh Surgery in Women With Pelvic Organ Prolapse

Important dates

Study start
2022
Primary completion
2023
Study completion
2027
First posted
Jan 12, 2023
Registry last updated
Apr 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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