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Recruiting NCT07730749

Long Term Follow Up Of Transvaginal Cystocele Repair Using Four Armed Collagen Coated Polyester Mesh

Observational Long Term Follow-Up Transvaginal Cystocele Repair Four Armed Collagen Polyester Mesh

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: transvaginal cystocele repair.
Who it may be relevant to
Registry conditions: Long Term Follow-Up, Transvaginal Cystocele Repair, Four Armed Collagen, Polyester Mesh. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Long Term Follow Up Of Transvaginal Cystocele Repair Using Four Armed Collagen Coated Polyester Mesh; Retrospective Cohort Study With Prospective Long-term Follow-up

Overview

This study aims to assess safety and efficacy of transvaginal repair of cystocele using four armed collagen coated polyester mesh beyond 5 years postoperatively.

Detailed description

Cystocele, also known as anterior vaginal wall prolapse, is a common condition in females, particularly those with or without uterine prolapse.

Traditionally, cystocele repair has been performed using native tissue suturing techniques. This method involves reinforcing the weakened vaginal wall by plicating and tightening the patient's tissues without introducing any foreign material. While suture repair is associated with fewer foreign body complications, long-term studies have reported notable recurrence rates, leading some surgeons to seek alternative methods.

Mesh insertion involves placing a synthetic material underneath the bladder to reinforce the vaginal wall and improve long-term anatomical outcomes. Although mesh repairs initially showed promising results in reducing recurrence, concerns have arisen regarding complications such as mesh erosion, chronic pelvic pain, and dyspareunia.

Interventions

  • Procedure transvaginal cystocele repair
    Patients who undergo transvaginal cystocele repair using four-armed collagen coated polyester mesh.

Primary outcome measures

  • Long-term anatomical success rate [Time frame: 5 years of follow-up postoperatively]
Secondary outcome measures (4)
  • Functional improvement [Time frame: 5 years of follow-up postoperatively]
  • Sexual function [Time frame: 5 years of follow-up postoperatively]
  • Long-term complications [Time frame: 5 years of follow-up postoperatively]
  • Assesment of quality of life [Time frame: 5 years of follow-up postoperatively]

Eligibility criteria

Inclusion criteria

  • Data of patients who underwent transvaginal cystocele repair using four-armed collagen coated polyester mesh

Exclusion criteria

  • Patients with insufficient postoperative follow-up data.
  • Patients with incomplete or missing medical records.
  • Patients undergone radiation, laser therapy, or chemotherapy in the pelvic area postoperatively.
  • Patients newly discovered uncontrolled diabetes mellitus.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Ain Shams University — Cairo

Identifiers

NCT: NCT07730749 · FMASU MS 473/2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗