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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Ibrahem M Abdelghany, MBBCH
- 電話番号：00201063256605
- メール：IbrahemAbdelghany@med.asu.edu.eg
研究場所
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Cairo Governorate
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Cairo、Cairo Governorate、エジプト、11591
- 募集
- Ain Shams University
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コンタクト：
- Ibrahem M Abdelghany, MBBCH
- 電話番号：00201063256605
- メール：IbrahemAbdelghany@med.asu.edu.eg
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Long-term anatomical success rate
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Functional improvement
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- FMASU MS 473/2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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