Comparing the Manchester procedure versus vaginal hysterectomy for uterine prolapse
Manchester Procedure Versus Vaginal Hysterectomy for Women With Uterine Prolapse: A Multi-Center Randomized Controlled Study (The Fin-UP Trial)
This study tests whether the Manchester procedure or vaginal hysterectomy works better for women with symptomatic uterine prolapse over a two-year follow-up.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 426 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Female |
| Sponsor | Tampere University Hospital Academic / other |
| Locations | 6 sites (Helsinki and 5 other locations) |
| Trial ID | NCT07566949 on ClinicalTrials.gov |
What this trial studies
The Fin-UP trial randomly assigns women with symptomatic uterine prolapse to either the uterus-preserving Manchester procedure or to vaginal hysterectomy with apical suspension in a 1:1 parallel-group design. The primary outcome is a composite success measure at follow-up (no prolapse beyond the hymen, no bulge symptoms, and no retreatment). Secondary outcomes include anatomical results, pelvic floor symptoms, quality of life, sexual function, satisfaction, perioperative parameters, and adverse events. A total of 426 participants will be followed at 1, 2, 5, and 10 years to capture both short- and long-term outcomes.
Who should consider this trial
Good fit: Women over 18 with symptomatic pelvic organ prolapse stage 2 or higher (uterine descent meeting POP‑Q criteria), fit for elective vaginal surgery, and with no prior POP surgery are the ideal candidates.
Not a fit: Women planning future pregnancy, those with active or suspected uterine/cervical malignancy, abnormal uterine bleeding, or other contraindications to uterine preservation or vaginal surgery are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, the Manchester procedure could provide a uterus-preserving, less invasive option with similar or better long-term success and faster recovery compared with vaginal hysterectomy.
How similar studies have performed: Existing observational studies suggest short-term advantages for the Manchester procedure, but randomized and long-term comparative evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Helsinki and 5 other locations
- Helsinki University Hospital — Helsinki, Finland (Recruiting)
- Hospital Nova, The Wellbeing Services County of Central Finland — Jyväskylä, Finland (Recruiting)
- Kuopio University Hospital — Kuopio, Finland (Recruiting)
- Oulu University Hospital — Oulu, Finland (Recruiting)
- Tampere University Hospital — Tampere, Finland (Recruiting)
- Turku University Hospital — Turku, Finland (Recruiting)
Study contacts
- Study coordinator: Päivi K Karjalainen, MD, PhD
- Email: paivi.karjalainen@hyvaks.fi
- Phone: +358142695512
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.