Vaginal Adventitia Reserved and Anatomical Implant Technique of Transvaginal Mesh Procedure for Pelvic Organ Prolapse

Vaginal Adventitia Reserved and Anatomical Implant Technique of Transvaginal Mesh Procedure for Pelvic Organ Prolapse: 13-year Surgical Results With 589 Cases

After obtaining an institutional ethics approval (#2021833), the investigators retrospectively reviewed patients with Pelvic organ prolapse (POP) who underwent Transvaginal Mesh (TVM) in their hospital during June 2008 and December 2020. The goal of this observational study is to introduce the Vaginal Adventitia Reserved and Anatomical Implant Technique in Transvaginal mesh surgery, and to report long term efficacy and safety results of this technique. The main questions it aims to answer are:

• How to reduce the potential risk of mesh-related complications when performing TVM?
• How effective is the use of the Vaginal Adventitia Reserved and Anatomical Implant Technique when performing TVM? Participants will be asked to fill the Pelvic Floor Distress Inventory (PFDI-20) at final follow-up, and the Prosthesis/Graft Complication Classification Code was used to record the mesh-related complications.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: TVM using the Vaginal Adventitia Reserved and Anatomical Implant Technique

Detailed Description

Patients and materials The investigators retrospective reviewed consecutive patients with stage II to IV Pelvic organ prolapse (POP) who underwent Transvaginal Mesh (TVM) at their center from June 2008 to December 2020. The Vaginal Adventitia Reserved and Anatomical Implant Technique was performed on all patients. Informed consent was obtained from all included patients. Approval was obtained from the institutional ethics committee of our hospital (West China Hospital, Sichuan University).

The pre-cut mesh kits including Gynecare Prolift® (Ethicon, Sommerville, NJ, USA), Perigee (AMS, Minnetonka, MN, USA), and Gynecare Prosima® (Ethicon, Sommerville, NJ, USA) and self-cut mesh Gynemesh (Ethicon, Sommerville, NJ, USA) were applied for transvaginal mesh repair in this study. Surgery was performed by an experienced surgeon (Dr. HS), utilizing the vaginal adventitia reserved and anatomical implant technique.

Outcome measures The effect of operation was assessed using both objective and subjective measures. The objective assessment (anatomic assessment) of success was that the nadir of prolapse never reached the point 0 (the level of hymen). The subjective assessment of success was the absence of prolapse symptoms. Chinese version of the Pelvic Floor Distress Inventory (PFDI-20) was also utilized for assessing the outcomes. Prosthesis/Graft Complication Classification Code was used to record the mesh-related complications.

Data analysis Statistical analysis was performed via the commercially available statistical package (SPSS) 22.0 for Windows (SPSS, Chicago, IL, USA). Categorical variables were represented using frequency and percentages and compared using the chi-square test. Continuous variables in accord with normal distribution were described using means and standard deviations (SDs) and analyzed using the Student's t-test. Statistical significance was defined at P < 0.05.

• Study Type: Observational
• Enrollment (Actual): 589

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Patients with POP who underwent TVM using the Vaginal Adventitia Reserved and Anatomical Implant Technique at the investigators' center from June 2008 to December 2020.

Description

Inclusion Criteria:

• Age >18 yr
• Clinical diagnosis of pelvic organ prolapse
• Pelvic organ prolapse-quantification (POP-Q) > II stage
• Patients underwent TVM using the Vaginal Adventitia Reserved and Anatomical Implant Technique

Exclusion Criteria:

• Patients who refused to participate in the study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients underwent TVM using the Vaginal Adventitia Reserved and Anatomical Implant Technique; Patients with pelvic organ prolapse who underwent TVM using the Vaginal Adventitia Reserved and Anatomical Implant Technique between June 2008 and December 2020	Procedure: TVM using the Vaginal Adventitia Reserved and Anatomical Implant Technique; The Transvaginal mesh procedure with Vaginal Adventitia Reserved and Anatomical Implant Technique for the treatment of POP. The Cefoxitin Injection Solution was used for Prophylactic antibiotics; Other Names: Cefoxitin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic Organ Prolapse-Quantification (POP-Q) scores	The POP-Q system was used to assess the pelvic organ prolapse	The time frame was from the date of surgery to the date of final follow-up, ranging from 9 to 156 months.
complication	Prosthesis/Graft Complication Classification Code was used to record the mesh-related complications	The time frame was from the date of surgery to the date of final follow-up, ranging from 9 to 156 months.
Pelvic Floor Distress Inventory (PFDI-20) scores	The PFDI-20 was used to assess pelvic floor symptoms and associated bother and has 3 subscales: the pelvic organ prolapse distress inventory (POPDI)(0-300); the colorectal-anal distress inventory (CRADI)(0-400); and the urinary distress inventory (UDI)(0-300). Higher scores indicted greater symptom bother.	The time frame was from the date of surgery to the date of final follow-up, ranging from 9 to 156 months.
Female Sexual Function Index (FSFI) scores	FSFI was used to assess the sexual function, which was a validated questionnaire comprised of 19 items. FSFI's total score ranged from 2 to 36; the higher the score, the severer the sexual dysfunction.	The time frame was from the date of surgery to the date of final follow-up, ranging from 9 to 156 months.

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2022
• Primary Completion (ACTUAL): November 30, 2022
• Study Completion (ACTUAL): November 30, 2022

Study Registration Dates

• First Submitted: December 18, 2022
• First Submitted That Met QC Criteria: January 28, 2023
• First Posted (ACTUAL): February 1, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2023
• Last Update Submitted That Met QC Criteria: January 28, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Complication; Pelvic organ prolapse; Transvaginal Mesh Procedure
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse; Anti-Infective Agents; Anti-Bacterial Agents; Cefoxitin
• Other Study ID Numbers: 2021833

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes