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

6 de maio de 2026 atualizado por: 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

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

426

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Finlândia
      • Helsinki, Finlândia
      • Jyväskylä, Finlândia
        • Recrutamento
        • Hospital Nova, The Wellbeing Services County of Central Finland
        • Contato:
      • Kuopio, Finlândia
      • Oulu, Finlândia
        • Recrutamento
        • Oulu University Hospital
        • Contato:
      • Tampere, Finlândia
        • Recrutamento
        • Tampere University Hospital
        • Contato:
      • Turku, Finlândia
        • Recrutamento
        • Turku University Hospital
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: The Manchester procedure
Procedimento: 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.
Outros nomes:
  • Fothergill's operation
  • Manchester-Fothergill procedure
Comparador Ativo: Vaginal Hysterectomy
Procedimento: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Success at two year follow-up
Prazo: 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

Medidas de resultados secundários

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Tampere University Hospital

Colaboradores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de maio de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2033

Conclusão do estudo (Estimado)

1 de dezembro de 2041

Datas de inscrição no estudo

Enviado pela primeira vez

8 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de abril de 2026

Primeira postagem (Real)

5 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de maio de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • R25060

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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