Uterine ProlapseFin-UPNCT07566949
The Finnish Uterine Prolapse Surgery Trial (The Fin-UP Trial)
A study testing Manchester procedure and Vaginal hysterectomy in people with Uterine Prolapse and Pelvic Organ Prolapse Vaginal Surgery, run by Tampere University Hospital at 6 sites in Finland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Uterine Prolapse, Pelvic Organ Prolapse Vaginal Surgery, Pelvic Organ Prolapse (POP)
- What is being tested?
- Manchester procedure and Vaginal hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 426 participants
- Where
- 6 sitesFinland
- Study dates
- May 2026to Dec 2041
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Finland6 sites, 6 recruiting
- Recruiting
Helsinki University Hospital
Helsinki
Tomi Mikkola, Professor, +35894711, tomi.mikkola@hus.fi
Camilla Isaksson, MD, PhD, camilla.isaksson@hus.fi
- Recruiting
Hospital Nova, The Wellbeing Services County of Central Finland
Jyväskylä
Päivi K Karjalainen, MD, PhD, +35814 2695512, paivi.karjalainen@hyvaks.fi
- Recruiting
Kuopio University Hospital
Kuopio
Kaisa Raatikainen, Docent, +358 17 173311, kaisa.e.raatikainen@pshyvinvointialue.fi
- Recruiting
Oulu University Hospital
Oulu
Henna-Riikka Rossi, MD, PhD, +358 50 579 4230, henna.rossi@pohde.fi
- Recruiting
Tampere University Hospital
Tampere
Kirsi Kuismanen, MD, PhD, +358 44 4739961, kirsi.kuismanen@pirha.fi
- Recruiting
Turku University Hospital
Turku
Kaisa Kurkijärvi, MD, PhD, +358 50 459 0301, kaisa.kurkijarvi@varha.fi
About this study
Official title: Manchester Procedure Versus Vaginal Hysterectomy for Women With Uterine Prolapse: A Multi-Center Randomized Controlled Study (The Fin-UP 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
Read the detailed description
Introduction Pelvic organ prolapse (POP) is a common condition affecting quality of life. Uterine prolapse, a type of apical prolapse, lacks a universally accepted surgical treatment, though vaginal hysterectomy with apical suspension (VH) has been the standard for years. Uterus-preserving procedures, such as the Manchester procedure (MP), are gaining popularity due to their less invasive nature and women's preference to retain the uterus. Limited evidence suggests MP may have a shorter recovery time and lower short-term recurrence rates compared to VH, but long-term benefits remain unclear. As most current data comes from observational studies, a randomized controlled trial is needed to reliably compare the effectiveness and patient outcomes of MP and VH.
Methods and analysis The Finnish Uterine Prolapse Surgery Trial (Fin-UP) is a randomized, controlled, parallel-group (1:1 ratio) superiority trial with two arms: (1) the MP and (2) VH. Patients with symptomatic POP stage 2 or higher, with uterine descent of at least stage 2, and with POP-Q point D ≤ minus 1 are eligible. The primary outcome is the composite outcome of success defined as the absence of POP beyond the hymen; the absence of bulge symptoms; and the absence of retreatment for POP. Secondary outcomes include anatomical outcomes, pelvic floor symptoms, quality of life, sexual function, satisfaction, perioperative parameters, and adverse events. Follow-up will take place at 1, 2, 5, and 10 years. 426 participants will be recruited, providing 80% power (α=0.05) to detect an 11% difference between groups in the primary outcome, allowing for a 10% loss to follow-up.
Ethics and dissemination Ethical approval for the trial has been obtained from the Ethics Committee of the Wellbeing Services County of Pirkanmaa (ETL-code R25060). The findings will be published in peer-reviewed journals and result in PhD theses. The data will provide important long-term clinical information that will help to unify the very commonly performed prolapse surgery in Finland.
- Being tested
- Manchester procedure, Vaginal hysterectomy
- Keywords
- Uterine prolapse, Pelvic organ prolapse, Manchester procedure, Vaginal hysterectomy, Vaginal surgery
- Medical subject headings
- Uterine Prolapse, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manchester procedureProcedure or surgery
Also called Fothergill's operation, Manchester-Fothergill procedure
The vaginal epithelium around the cervix is circumcised, and the bladder is dissected off the cervix. The posterior peritoneum is opened if considered technically feasible and clinically appropriate. The cardinal-uterosacral ligament complex is clamped, transected, and ligated. The ligament complex is sutured to the proximal part of the anterior cervix. The cervix is amputated using diathermy, and the patency of the cervical canal is ensured. The vaginal epithelium is sutured circumferentially around the remaining cervical stump. Concomitant anterior and posterior colporrhaphy as well as perineorrhaphy will be performed when deemed indicated by the surgeon.
Vaginal hysterectomyProcedure or surgery
The vaginal epithelium around the cervix is circumcised, and the bladder is dissected off the cervix. Both the anterior and posterior peritoneum are opened. The cardinal-uterosacral ligament complex is clamped, transected, and ligated. The uterus is removed in multiple steps by clamps and sutures. The adnexa are checked for abnormalities. Apical suspension is performed using a 0-polyglactin (braided, delayed-absorbable) suture. The suture incorporates the ligament complex on both sides and passes twice through the peritoneum and the full thickness of the posterior vaginal wall, exiting into the posterior fornix and returning through the same tissue layers. The suture is tightened to obliterate the cul-de-sac. In case of a large enterocele, an additional transverse suture may be placed proximally. The ligament pedicles are tied together in the midline. The vaginal wall is closed. Concomitant anterior and posterior colporrhaphy as well as perineorrhaphy will be performed when indicated.
| Study group | Role | What they receive |
|---|---|---|
| The Manchester procedure | Experimental | Not described Receives: Procedure: Manchester procedure |
| Vaginal Hysterectomy | Active comparator | Not described Receives: Procedure: Vaginal hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success at two year follow-up
Success is defined as a composite outcome including
- the absence of POP beyond the hymen in any compartment (POP-Q Aa, Ap, Ba, Bp, C (and D for those in the MP group) all ≤ 0;), and
- the absence of bulge symptoms defined as a negative response to the question, "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?" (PFDI-20 question 3 score 0), and
- the absence of retreatment (surgery and/or pessary treatment for POP indication).
Participants are classified as having achieved success if they meet all criteria.
Measured: Two year follow-up
Secondary outcomes (19)
Patient Global Impression of Improvement (PGI-I)
7 step Likert scale (Much better - somewhat better - a little better - no change - a little worse - somewhat worse - much worse)
Measured: 1, 2, 5 and 10 year follow-up
Patient Acceptable Symptom State (PASS)
Defined by the question "When taking into account all your symptoms related to prolapse, do you consider your current state good enough?" (yes/no)
Measured: 1, 2, 5 and 10 year follow-up
Pelvic Floor Distress Inventory-20 (PFDI-20)
Questionnaire, 0 to 300, higher is worse
Measured: 1, 2, 5 and 10 year follow-up
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
Questionnaire, 0 to 48, higher indicates better sexual function
Measured: 1, 2, 5 and 10 year follow-up
Generic health related quality of life measured by EuroQol-5D-5L
Questionnaire, 0 to 1, higher is better
Measured: 1, 2, 5 and 10 year follow-up
Pelvic Organ Prolapse Quantification System (POP-Q)
Anatomical outcomes assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system. Measurements include points Aa, Ap, Ba, Bp, C, and D where applicable as well as genital hiatus (GH), perineal body (PB), and total vaginal length (TVL). All measurements are recorded in centimeters relative to the hymen (for POP-Q points) or as linear measurements (GH, PB, TVL). For POP-Q points, negative values indicate positions above the hymen and positive values indicate descent beyond the hymen, with higher values representing worse prolapse.
Measured: 2 and 5 year follow-up
Reoperation for pelvic organ prolapse
Proportion
Measured: 1, 2, 5 and 10 years
Pessary treatment for pelvic organ prolapse or urinary incontinence
Proportion.
Measured: 1, 2, 5 and 10 year follow-up
Further treatment for associated conditions
Proportion
Measured: 1, 2, 5 and 10 year follow-up
Adverse events
Including blood loss >500 ml, bladder or ureter injury, bowel injury, hematoma, need for blood transfusion, deep vein thrombosis, pulmonary embolism, prolonged need for catheterisation, infection, postoperative hemorrhage, need for reoperation due to complication, death, complication with anestesia or other complication. The Clavien-Dindo classification of each complication will be reported.
Measured: From operation to two months
Operating time
Minutes
Measured: Perioperative
Blood loss
ml
Measured: Perioperative
Insertion of IUD
Yes/no (MP-group)
Measured: Perioperative
Weight of uterus
VH-group, g
Measured: Perioperative
Initiation of antithrombotic profylaxis
Yes/no
Measured: Perioperative
Duration of hospitalization
Days spent in hospital, including the day of operation
Measured: Days from operation to discharge, assessed at 1 year follow up
Duration of sick leave
Days, obtained from KELA registry
Measured: From operation to last day of sick leave, assessed at 1 year follow-up
Long term complications
Such as menstrual problems or hematometra, stenosis of the cervical canal, difficulties with uterine access during cervical or endometrial sampling or intrauterine device insertion, endometrial hyperplasia, abnormal cervical findings, malignancy of the uterine body or cervix (MP-group), or other
Measured: 1, 2, 5 and 10 year follow-up
Success at five year follow-up
Success is defined as a composite outcome including
- the absence of POP beyond the hymen in any compartment (POP-Q Aa, Ap, Ba, Bp, C (and D for those in the MP group) all ≤ 0;), and
- the absence of bulge symptoms defined as a negative response to the question, "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?" (PFDI-20 question 3 score 0), and
- the absence of retreatment (surgery and/or pessary treatment for POP indication).
Participants are classified as having achieved success if they meet all criteria.
Measured: Five year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study startMay 2026 (estimated)
- Primary completionDec 2033 (estimated)
- Study completionDec 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The Finnish Uterine Prolapse Surgery Trial (The Fin-UP trial) is designed as a prospective, randomized, controlled, parallel-group (1:1 ratio) superiority trial with two arms: (1) the Manchester procedure and (2) Vaginal Hysterectomy.
- Masking
- None (open label)
- Enrolment
- 426 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, Turku University Hospital, Kuopio University Hospital, Oulu University Hospital, Hospital Nova, Central Finland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566949
- Sponsor's protocol ID
- R25060
- Acronym
- Fin-UP
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided