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

2026년 5월 6일 업데이트: 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

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

426

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 핀란드
      • Helsinki, 핀란드
      • Jyväskylä, 핀란드
        • 모병
        • Hospital Nova, The Wellbeing Services County of Central Finland
        • 연락하다:
      • Kuopio, 핀란드
      • Oulu, 핀란드
        • 모병
        • Oulu University Hospital
        • 연락하다:
      • Tampere, 핀란드
        • 모병
        • Tampere University Hospital
        • 연락하다:
      • Turku, 핀란드
        • 모병
        • Turku University Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: The Manchester procedure
절차: 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.
다른 이름들:
  • Fothergill's operation
  • Manchester-Fothergill procedure
활성 비교기: Vaginal Hysterectomy
절차: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Success at two year follow-up
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Patient Global Impression of Improvement (PGI-I)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 1, 2, 5 and 10 years
Proportion
1, 2, 5 and 10 years
Pessary treatment for pelvic organ prolapse or urinary incontinence
기간: 1, 2, 5 and 10 year follow-up
Proportion.
1, 2, 5 and 10 year follow-up
Further treatment for associated conditions
기간: 1, 2, 5 and 10 year follow-up
Proportion
1, 2, 5 and 10 year follow-up
Adverse events
기간: 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
기간: Perioperative
Minutes
Perioperative
Blood loss
기간: Perioperative
ml
Perioperative
Insertion of IUD
기간: Perioperative
Yes/no (MP-group)
Perioperative
Weight of uterus
기간: Perioperative
VH-group, g
Perioperative
Initiation of antithrombotic profylaxis
기간: Perioperative
Yes/no
Perioperative
Duration of hospitalization
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Tampere University Hospital

협력자

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 5월 1일

기본 완료 (추정된)

2033년 12월 1일

연구 완료 (추정된)

2041년 12월 1일

연구 등록 날짜

최초 제출

2026년 4월 8일

QC 기준을 충족하는 최초 제출

2026년 4월 27일

처음 게시됨 (실제)

2026년 5월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 6일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • R25060

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Manchester procedure에 대한 임상 시험

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스폰서 및 공동 작업자

건강 상태

약물 개입

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정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다