Four Armed Collagen, Long Term Follow-Up, Polyester Mesh, Transvaginal Cystocele Repair
Conditions
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.
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.
Interventions
PROCEDUREtransvaginal cystocele repair
Patients who undergo transvaginal cystocele repair using four-armed collagen coated polyester mesh.
Sponsors
Ain Shams University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-term anatomical success rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Functional improvement | 5 years of follow-up postoperatively | Sustained improvement in urinary symptoms will be recorded. |
| Sexual function | 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 |
| Long-term complications | 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. |
| Assesment of quality of life | 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 |
Countries
Egypt
Contacts
CONTACTIbrahem M Abdelghany, MBBCH
Outcome results
None listed