Actively Recruiting
The Finnish Uterine Prolapse Surgery Trial (The Fin-UP Trial)
Led by Tampere University Hospital · Updated on 2026-05-11
426
Participants Needed
6
Research Sites
813 weeks
Total Duration
On this page
Sponsors
T
Tampere University Hospital
Lead Sponsor
H
Helsinki University Central Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
The Finnish Uterine Prolapse Surgery Trial (The Fin-UP Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Helsinki University Hospital
Helsinki, Finland
Actively Recruiting
2
Hospital Nova, The Wellbeing Services County of Central Finland
Jyväskylä, Finland
Actively Recruiting
3
Kuopio University Hospital
Kuopio, Finland
Actively Recruiting
4
Oulu University Hospital
Oulu, Finland
Actively Recruiting
5
Tampere University Hospital
Tampere, Finland
Actively Recruiting
6
Turku University Hospital
Turku, Finland
Actively Recruiting
Research Team
P
Päivi K Karjalainen, MD, PhD
CONTACT
A
Anniina Karioja, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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