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 volunteersQualifiers
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
Cohort
Retrospective
Treatments tested in this trial
transvaginal cystocele repair
Procedure/SurgeryPatients who undergo transvaginal cystocele repair using four-armed collagen coated polyester mesh.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Functional improvement
Sustained improvement in urinary symptoms will be recorded.
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
Long-term complications
Long-term complications including groin pain, urinary retention, vaginal shortening, infection, mesh erosion or need for mesh removal will be recorded.
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
Sponsors and contacts
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