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The Finnish Uterine Prolapse Surgery Trial (The Fin-UP Trial) (Fin-UP)

2026年5月6日 更新者：Tampere University Hospital

Manchester Procedure Versus Vaginal Hysterectomy for Women With Uterine Prolapse: A Multi-Center Randomized Controlled Study (The Fin-UP Trial)

The goal of this clinical trial is to compare the Manchester procedure and vaginal hysterectomy in treating patients with symptomatic uterine prolapse.

The main question it aims to answer is:

• What is the difference in the success rates at the the two year follow-up

Participants will:

  • be randomized in either the Manchester procedure or vaginal hysterectomy group and operated as such
  • visit the clinic at 2 and 5 years after the operation
  • fill in questionnaires at 1, 2, 5 and 10 years after the operation

調査の概要

状態

募集

条件

介入・治療

詳細な説明

Introduction Pelvic organ prolapse (POP) is a common condition affecting quality of life. Uterine prolapse, a type of apical prolapse, lacks a universally accepted surgical treatment, though vaginal hysterectomy with apical suspension (VH) has been the standard for years. Uterus-preserving procedures, such as the Manchester procedure (MP), are gaining popularity due to their less invasive nature and women's preference to retain the uterus. Limited evidence suggests MP may have a shorter recovery time and lower short-term recurrence rates compared to VH, but long-term benefits remain unclear. As most current data comes from observational studies, a randomized controlled trial is needed to reliably compare the effectiveness and patient outcomes of MP and VH.

Methods and analysis The Finnish Uterine Prolapse Surgery Trial (Fin-UP) is a randomized, controlled, parallel-group (1:1 ratio) superiority trial with two arms: (1) the MP and (2) VH. Patients with symptomatic POP stage 2 or higher, with uterine descent of at least stage 2, and with POP-Q point D ≤ minus 1 are eligible. The primary outcome is the composite outcome of success defined as the absence of POP beyond the hymen; the absence of bulge symptoms; and the absence of retreatment for POP. Secondary outcomes include anatomical outcomes, pelvic floor symptoms, quality of life, sexual function, satisfaction, perioperative parameters, and adverse events. Follow-up will take place at 1, 2, 5, and 10 years. 426 participants will be recruited, providing 80% power (α=0.05) to detect an 11% difference between groups in the primary outcome, allowing for a 10% loss to follow-up.

Ethics and dissemination Ethical approval for the trial has been obtained from the Ethics Committee of the Wellbeing Services County of Pirkanmaa (ETL-code R25060). The findings will be published in peer-reviewed journals and result in PhD theses. The data will provide important long-term clinical information that will help to unify the very commonly performed prolapse surgery in Finland.

研究の種類

介入

入学 (推定)

426

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • フィンランド
      • Helsinki、フィンランド
        • 募集
        • Helsinki University Hospital
        • コンタクト：
        • コンタクト：
      • Jyväskylä、フィンランド
        • 募集
        • Hospital Nova, The Wellbeing Services County of Central Finland
        • コンタクト：
      • Kuopio、フィンランド
      • Oulu、フィンランド
        • 募集
        • Oulu University Hospital
        • コンタクト：
      • Tampere、フィンランド
        • 募集
        • Tampere University Hospital
        • コンタクト：
      • Turku、フィンランド
        • 募集
        • Turku University Hospital
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

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

いいえ

説明

Inclusion Criteria:

  • Fit for elective vaginal surgery according to standard preoperative assessment
  • Women aged over 18 years
  • No previous POP surgery
  • Symptomatic POP stage 2 or higher, with uterine descent of at least stage 2 (POP-Q point C ≥ minus 1) and with POP-Q point D ≤ minus 1. Patients with concurrent anterior or posterior compartment defects will be included.

Exclusion Criteria:

  • Pregnancy or future plans of pregnancy
  • Active malignancy of any kind
  • Contraindications for uterine preservation, i.e. suspected cervical or uterine malignancy, abnormal cervical cytology, abnormal uterine bleeding, a history of endometrial hyperplasia with atypia, or a known hereditary cancer syndrome involving the uterus (e.g., Lynch syndrome). All patients will undergo a clinical examination and ultrasound assessment prior to recruitment. If clinically indicated, a Pap-smear and/or endometrial biopsy will be performed prior to inclusion.
  • Contraindication to vaginal hysterectomy (e.g. extensive intra-abdominal adhesions)
  • Patient's preference for uterine removal or preservation
  • Planned concomitant incontinence procedure
  • Inability to speak Finnish or Swedish, understand the purpose of the study, or commit to follow-up

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：The Manchester procedure
手順：Manchester procedure
The vaginal epithelium around the cervix is circumcised, and the bladder is dissected off the cervix. The posterior peritoneum is opened if considered technically feasible and clinically appropriate. The cardinal-uterosacral ligament complex is clamped, transected, and ligated. The ligament complex is sutured to the proximal part of the anterior cervix. The cervix is amputated using diathermy, and the patency of the cervical canal is ensured. The vaginal epithelium is sutured circumferentially around the remaining cervical stump. Concomitant anterior and posterior colporrhaphy as well as perineorrhaphy will be performed when deemed indicated by the surgeon.
他の名前：
  • Fothergill's operation
  • Manchester-Fothergill procedure
アクティブコンパレータ：Vaginal Hysterectomy
手順：Vaginal hysterectomy
The vaginal epithelium around the cervix is circumcised, and the bladder is dissected off the cervix. Both the anterior and posterior peritoneum are opened. The cardinal-uterosacral ligament complex is clamped, transected, and ligated. The uterus is removed in multiple steps by clamps and sutures. The adnexa are checked for abnormalities. Apical suspension is performed using a 0-polyglactin (braided, delayed-absorbable) suture. The suture incorporates the ligament complex on both sides and passes twice through the peritoneum and the full thickness of the posterior vaginal wall, exiting into the posterior fornix and returning through the same tissue layers. The suture is tightened to obliterate the cul-de-sac. In case of a large enterocele, an additional transverse suture may be placed proximally. The ligament pedicles are tied together in the midline. The vaginal wall is closed. Concomitant anterior and posterior colporrhaphy as well as perineorrhaphy will be performed when indicated.

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
Success at two year follow-up
時間枠：Two year follow-up

Success is defined as a composite outcome including

  1. the absence of POP beyond the hymen in any compartment (POP-Q Aa, Ap, Ba, Bp, C (and D for those in the MP group) all ≤ 0;), and
  2. the absence of bulge symptoms defined as a negative response to the question, "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?" (PFDI-20 question 3 score 0), and
  3. the absence of retreatment (surgery and/or pessary treatment for POP indication).

Participants are classified as having achieved success if they meet all criteria.
Two year follow-up

二次結果の測定

結果測定
メジャーの説明
時間枠
Patient Global Impression of Improvement (PGI-I)
時間枠：1, 2, 5 and 10 year follow-up
7 step Likert scale (Much better - somewhat better - a little better - no change - a little worse - somewhat worse - much worse)
1, 2, 5 and 10 year follow-up
Patient Acceptable Symptom State (PASS)
時間枠：1, 2, 5 and 10 year follow-up
Defined by the question "When taking into account all your symptoms related to prolapse, do you consider your current state good enough?" (yes/no)
1, 2, 5 and 10 year follow-up
Pelvic Floor Distress Inventory-20 (PFDI-20)
時間枠：1, 2, 5 and 10 year follow-up
Questionnaire, 0 to 300, higher is worse
1, 2, 5 and 10 year follow-up
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
時間枠：1, 2, 5 and 10 year follow-up
Questionnaire, 0 to 48, higher indicates better sexual function
1, 2, 5 and 10 year follow-up
Generic health related quality of life measured by EuroQol-5D-5L
時間枠：1, 2, 5 and 10 year follow-up
Questionnaire, 0 to 1, higher is better
1, 2, 5 and 10 year follow-up
Reoperation for pelvic organ prolapse
時間枠：1, 2, 5 and 10 years
Proportion
1, 2, 5 and 10 years
Pessary treatment for pelvic organ prolapse or urinary incontinence
時間枠：1, 2, 5 and 10 year follow-up
Proportion.
1, 2, 5 and 10 year follow-up
Further treatment for associated conditions
時間枠：1, 2, 5 and 10 year follow-up
Proportion
1, 2, 5 and 10 year follow-up
Adverse events
時間枠：From operation to two months
Including blood loss >500 ml, bladder or ureter injury, bowel injury, hematoma, need for blood transfusion, deep vein thrombosis, pulmonary embolism, prolonged need for catheterisation, infection, postoperative hemorrhage, need for reoperation due to complication, death, complication with anestesia or other complication. The Clavien-Dindo classification of each complication will be reported.
From operation to two months
Operating time
時間枠：Perioperative
Minutes
Perioperative
Blood loss
時間枠：Perioperative
ml
Perioperative
Insertion of IUD
時間枠：Perioperative
Yes/no (MP-group)
Perioperative
Weight of uterus
時間枠：Perioperative
VH-group, g
Perioperative
Initiation of antithrombotic profylaxis
時間枠：Perioperative
Yes/no
Perioperative
Duration of hospitalization
時間枠：Days from operation to discharge, assessed at 1 year follow up
Days spent in hospital, including the day of operation
Days from operation to discharge, assessed at 1 year follow up
Duration of sick leave
時間枠：From operation to last day of sick leave, assessed at 1 year follow-up
Days, obtained from KELA registry
From operation to last day of sick leave, assessed at 1 year follow-up
Long term complications
時間枠：1, 2, 5 and 10 year follow-up
Such as menstrual problems or hematometra, stenosis of the cervical canal, difficulties with uterine access during cervical or endometrial sampling or intrauterine device insertion, endometrial hyperplasia, abnormal cervical findings, malignancy of the uterine body or cervix (MP-group), or other
1, 2, 5 and 10 year follow-up
Success at five year follow-up
時間枠：Five year follow-up

Success is defined as a composite outcome including

  1. the absence of POP beyond the hymen in any compartment (POP-Q Aa, Ap, Ba, Bp, C (and D for those in the MP group) all ≤ 0;), and
  2. the absence of bulge symptoms defined as a negative response to the question, "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?" (PFDI-20 question 3 score 0), and
  3. the absence of retreatment (surgery and/or pessary treatment for POP indication).

Participants are classified as having achieved success if they meet all criteria.
Five year follow-up
Pelvic Organ Prolapse Quantification System (POP-Q)
時間枠：2 and 5 year follow-up
Anatomical outcomes assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system. Measurements include points Aa, Ap, Ba, Bp, C, and D where applicable as well as genital hiatus (GH), perineal body (PB), and total vaginal length (TVL). All measurements are recorded in centimeters relative to the hymen (for POP-Q points) or as linear measurements (GH, PB, TVL). For POP-Q points, negative values indicate positions above the hymen and positive values indicate descent beyond the hymen, with higher values representing worse prolapse.
2 and 5 year follow-up

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Tampere University Hospital

協力者

Turku University Hospital
Helsinki University Central Hospital
Oulu University Hospital
Kuopio University Hospital
Hospital Nova, Central Finland

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年5月1日

一次修了 (推定)

2033年12月1日

研究の完了 (推定)

2041年12月1日

試験登録日

最初に提出

2026年4月8日

QC基準を満たした最初の提出物

2026年4月27日

最初の投稿 (実際)

2026年5月5日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月11日

QC基準を満たした最後の更新が送信されました

2026年5月6日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • R25060

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?

未定

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

いいえ

米国FDA規制機器製品の研究

いいえ

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