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

NCT05707533 | Completed DMC

• 1 other identifier: 2021833
• Study Type: observational
• Target: 589
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic organ prolapse; Complication; Transvaginal Mesh Procedure

Outcome Measures

Primary Outcomes (4)

• 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.

Study Arms (1)

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

Interventions

TVM using the Vaginal Adventitia Reserved and Anatomical Implant Technique PROCEDURE

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

Also known as: Cefoxitin

Patients underwent TVM using the Vaginal Adventitia Reserved and Anatomical Implant Technique

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients who refused to participate in the study.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Cefoxitin

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephamycins; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Wei-min Li, PhD.

  West China Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 18, 2022
• First Posted: February 1, 2023
• Study Start: August 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

CN (1)