The Finnish Uterine Prolapse Surgery Trial (The Fin-UP Trial) (Fin-UP)

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

Study Overview

• Status: Recruiting
• Conditions: Uterine Prolapse; Pelvic Organ Prolapse Vaginal Surgery; Pelvic Organ Prolapse (POP)
• Intervention / Treatment: Procedure: Manchester procedure; Procedure: Vaginal hysterectomy

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.

• Study Type: Interventional
• Enrollment (Estimated): 426
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Päivi K Karjalainen, MD, PhD; Phone Number: +358142695512; Email: paivi.karjalainen@hyvaks.fi
• Study Contact Backup: Name: Anniina Karioja, MD; Phone Number: +358331165005; Email: anniina.karioja@pirha.fi

Study Locations

• Finland
  • Helsinki, Finland
    • Recruiting
    • Helsinki University Hospital
    • Contact: Tomi Mikkola, Professor; Phone Number: +35894711; Email: tomi.mikkola@hus.fi
    • Contact: Camilla Isaksson, MD, PhD; Email: camilla.isaksson@hus.fi
  • Jyväskylä, Finland
    • Recruiting
    • Hospital Nova, The Wellbeing Services County of Central Finland
    • Contact: Päivi K Karjalainen, MD, PhD; Phone Number: +35814 2695512; Email: paivi.karjalainen@hyvaks.fi
  • Kuopio, Finland
    • Recruiting
    • Kuopio University Hospital
    • Contact: Kaisa Raatikainen, Docent; Phone Number: +358 17 173311; Email: kaisa.e.raatikainen@pshyvinvointialue.fi
  • Oulu, Finland
    • Recruiting
    • Oulu University Hospital
    • Contact: Henna-Riikka Rossi, MD, PhD; Phone Number: +358 50 579 4230; Email: henna.rossi@pohde.fi
  • Tampere, Finland
    • Recruiting
    • Tampere University Hospital
    • Contact: Kirsi Kuismanen, MD, PhD; Phone Number: +358 44 4739961; Email: kirsi.kuismanen@pirha.fi
  • Turku, Finland
    • Recruiting
    • Turku University Hospital
    • Contact: Kaisa Kurkijärvi, MD, PhD; Phone Number: +358 50 459 0301; Email: kaisa.kurkijarvi@varha.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The Manchester procedure	Procedure: Manchester 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.; Other Names: Fothergill's operation; Manchester-Fothergill procedure
Active Comparator: Vaginal Hysterectomy	Procedure: Vaginal hysterectomy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Two year follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	1, 2, 5 and 10 year follow-up
Pelvic Floor Distress Inventory-20 (PFDI-20)	Questionnaire, 0 to 300, higher is worse	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	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	1, 2, 5 and 10 year follow-up
Reoperation for pelvic organ prolapse	Proportion	1, 2, 5 and 10 years
Pessary treatment for pelvic organ prolapse or urinary incontinence	Proportion.	1, 2, 5 and 10 year follow-up
Further treatment for associated conditions	Proportion	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.	From operation to two months
Operating time	Minutes	Perioperative
Blood loss	ml	Perioperative
Insertion of IUD	Yes/no (MP-group)	Perioperative
Weight of uterus	VH-group, g	Perioperative
Initiation of antithrombotic profylaxis	Yes/no	Perioperative
Duration of hospitalization	Days spent in hospital, including the day of operation	Days from operation to discharge, assessed at 1 year follow up
Duration of sick leave	Days, obtained from KELA registry	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	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.	Five 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.	2 and 5 year follow-up

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: Turku University Hospital; Helsinki University Central Hospital; Oulu University Hospital; Kuopio University Hospital; Hospital Nova, Central Finland

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 1, 2033
• Study Completion (Estimated): December 1, 2041

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Uterine prolapse; Vaginal hysterectomy; Pelvic organ prolapse; Vaginal surgery; Manchester procedure
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Prolapse; Pathological Conditions, Signs and Symptoms; Pelvic Organ Prolapse; Uterine Prolapse; Surgical Procedures, Operative; Urogenital Surgical Procedures; Gynecologic Surgical Procedures; Hysterectomy; Hysterectomy, Vaginal
• Other Study ID Numbers: R25060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No