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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAin Shams University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • transvaginal cystocele repair

    Procedure/Surgery

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Study group1 intervention

Trial outcomes

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.

Time frame
5 years of follow-up postoperatively

Secondary outcomes

1

Functional improvement

Sustained improvement in urinary symptoms will be recorded.

Time frame
5 years of follow-up postoperatively
2

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

Time frame
5 years of follow-up postoperatively
3

Long-term complications

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

Time frame
5 years of follow-up postoperatively
4

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

Time frame
5 years of follow-up postoperatively

Other outcomes

Sponsors and contacts

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