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NCT Number: NCT07730749

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ain Shams University

Cairo, Cairo Governorate, 11591, Egypt

Location status: Recruiting

Location contact

Ibrahem M Abdelghany, MBBCH

CONTACT

[email protected]

00201063256605

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

transvaginal cystocele repair

Procedure

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

Primary outcomes

  1. Long-term anatomical success rate

    Time frame: 5 years of follow-up postoperatively

    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.

Secondary outcomes

  1. Functional improvement

    Time frame: 5 years of follow-up postoperatively

    Sustained improvement in urinary symptoms will be recorded.

  2. Sexual function

    Time frame: 5 years of follow-up postoperatively

    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

  3. Long-term complications

    Time frame: 5 years of follow-up postoperatively

    Long-term complications including groin pain, urinary retention, vaginal shortening, infection, mesh erosion or need for mesh removal will be recorded.

  4. Assesment of quality of life

    Time frame: 5 years of follow-up postoperatively

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Ibrahem M Abdelghany, MBBCH

CONTACT

[email protected]

00201063256605

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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