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

RecruitingNAAges 18 Years - 100 YearsFemaleTampere University Hospital
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In plain words

What the trial is, and whether it could suit you

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: โ€ข 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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ minus 1) and with POP-Q point D โ‰ค 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
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What it tests

  • Manchester procedure
  • Vaginal hysterectomy
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Where

6 sites
Helsinki University Hospital
Helsinki, Finland
Hospital Nova, The Wellbeing Services County of Central Finland
Jyvรคskylรค, Finland
Kuopio University Hospital
Kuopio, Finland
Oulu University Hospital
Oulu, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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