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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Ibrahem M Abdelghany, MBBCH
- 전화번호: 00201063256605
- 이메일: IbrahemAbdelghany@med.asu.edu.eg
연구 장소
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Cairo Governorate
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Cairo, Cairo Governorate, 이집트, 11591
- 모병
- Ain Shams University
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연락하다:
- Ibrahem M Abdelghany, MBBCH
- 전화번호: 00201063256605
- 이메일: IbrahemAbdelghany@med.asu.edu.eg
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Study group
Patients who undergo transvaginal cystocele repair using four-armed collagen coated polyester mesh
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Patients who undergo transvaginal cystocele repair using four-armed collagen coated polyester mesh.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Long-term anatomical success rate
기간: 5 years of follow-up postoperatively
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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.
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5 years of follow-up postoperatively
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Functional improvement
기간: 5 years of follow-up postoperatively
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Sustained improvement in urinary symptoms will be recorded.
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5 years of follow-up postoperatively
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Sexual function
기간: 5 years of follow-up postoperatively
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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
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Long-term complications
기간: 5 years of follow-up postoperatively
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Long-term complications including groin pain, urinary retention, vaginal shortening, infection, mesh erosion or need for mesh removal will be recorded.
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5 years of follow-up postoperatively
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Assesment of quality of life
기간: 5 years of follow-up postoperatively
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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
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- FMASU MS 473/2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
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