The Finnish Uterine Prolapse Surgery Trial (The Fin-UP Trial)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-100
SponsorTampere University Hospital
About this 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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Manchester procedure
- Vaginal hysterectomy
Treatment groups
426 Participants
are divided into 2 treatment groupsSponsors and collaborators
Tampere University Hospital
Lead sponsor
Helsinki University Central Hospital
Collaborator
Turku University Hospital
Collaborator
Kuopio University Hospital
Collaborator
Oulu University Hospital
Collaborator
Hospital Nova, Central Finland
Collaborator
Source ClinicalTrials.gov