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

NCT07730749 | Recruiting

• 1 other identifier: FMASU MS 473/2026
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Long-term anatomical success rate

  Long-term anatomical success rate is defined as the absence of anterior vaginal wall prolapse or the presence of only Stage 0-I cystocele according to Pelvic Organ Prolapse Quantification (POP-Q) classification after 5 years of follow-up postoperatively.

  5 years of follow-up postoperatively

Secondary Outcomes (4)

• Functional improvement

  5 years of follow-up postoperatively

• Sexual function

  5 years of follow-up postoperatively

• Long-term complications

  5 years of follow-up postoperatively

• Assesment of quality of life

  5 years of follow-up postoperatively

Study Arms (1)

Study group

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

Procedure: transvaginal cystocele repair

Interventions

transvaginal cystocele repair PROCEDURE

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

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This retrospective cohort study with prospective long-term follow-up will be conducted on 20 patients at Ain Shams University Hospital.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Cairo Governorate, 11591, Egypt

RECRUITING

Central Study Contacts

Ibrahem M Abdelghany, MBBCH

CONTACT

00201063256605; IbrahemAbdelghany@med.asu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Urology, Faculty of Medicine, Ain Shams University, Egypt.

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start: June 29, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)