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

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

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

Study Overview

• Status: Recruiting
• Conditions: Long Term Follow-Up; Transvaginal Cystocele Repair; Four Armed Collagen; Polyester Mesh
• Intervention / Treatment: Procedure: transvaginal cystocele repair

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.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Ibrahem M Abdelghany, MBBCH; Phone Number: 00201063256605; Email: IbrahemAbdelghany@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 11591
      • Recruiting
      • Ain Shams University
      • Contact: Ibrahem M Abdelghany, MBBCH; Phone Number: 00201063256605; Email: IbrahemAbdelghany@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; Patients who undergo transvaginal cystocele repair using four-armed collagen coated polyester mesh	Procedure: transvaginal cystocele repair; Patients who undergo transvaginal cystocele repair using four-armed collagen coated polyester mesh.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional improvement	Sustained improvement in urinary symptoms will be recorded.	5 years of follow-up postoperatively
Sexual function	The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) is a validated, condition-specific questionnaire will be used to evaluate sexual function in women with pelvic floor disorders. It is a shortened form of the original 31-item PISQ, specifically designed for sexually active women experiencing pelvic organ prolapse (POP) and urinary incontinence (UI). The questionnaire consists of 12 self-administered questions that assess the impact of pelvic floor health over the past six months. It spans three primary domains: Behavioral-Emotive Domain (Questions 1-4): Focuses on desire, excitement, frequency, and overall sexual satisfaction. Physical Domain (Questions 5-9): Evaluates physical symptoms during sex, such as pain, urine leakage, and restrictions due to fear or vaginal bulging. Partner-Related Domain (Questions 10-12): Addresses the partner's erectile or ejaculatory function as it impacts sexual activity	5 years of follow-up postoperatively
Long-term complications	Long-term complications including groin pain, urinary retention, vaginal shortening, infection, mesh erosion or need for mesh removal will be recorded.	5 years of follow-up postoperatively
Assesment of quality of life	The Incontinence Impact Questionnaire - Short Form (IIQ-7) will be used to evaluate the quality of life. It is a condensed version of the original 30-item questionnaire, designed to evaluate life impact over the past month across physical, emotional, and social life areas. The IIQ-7 consists of 7 self-administered items divided into four clinical domains: Physical Activity (Items 1 & 2): Measures impact on household chores and physical recreation like walking or swimming. Travel (Items 3 & 4): Evaluates restrictions on entertainment outings and traveling by car or bus more than 30 minutes from home. Social Relationships (Item 5): Assesses participation in social activities outside the home. Emotional Health (Items 6 & 7): Tracks the burden on mental wellbeing, specifically feelings of nervousness, depression, or frustration	5 years of follow-up postoperatively

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: July 23, 2026
• First Submitted That Met QC Criteria: July 23, 2026
• First Posted (Actual): July 28, 2026

Study Record Updates

• Last Update Posted (Actual): July 28, 2026
• Last Update Submitted That Met QC Criteria: July 23, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: FMASU MS 473/2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No