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New treatment option for Uterine Prolapse
Official title The Finnish Uterine Prolapse Surgery Trial (The Fin-UP Trial)
ClinicalTrials.gov ID: NCT07566949
What this study is testing
- What it's testing
- 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
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100, women only
You may be able to join if
- 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...
You likely can't join if
- 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...
- Contraindication to vaginal hysterectomy (e.g. extensive intra-abdominal adhesions)
- Patient's preference for uterine removal or preservation
- Planned concomitant incontinence procedure
See the full eligibility 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Helsinki, Finland
- Jyväskylä, Finland
- Kuopio, Finland
- Oulu, Finland
- Tampere, Finland
- Turku, Finland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Helsinki, Finland; Jyväskylä, Finland; Kuopio, Finland; Oulu, Finland; Tampere, Finland; Turku, Finland. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.