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

NCT07566949 | Not Yet Recruiting

• 1 other identifier: R25060
• Study Type: interventional
• Target: 426
• Locations: 1 country
• Sites: 6

Brief 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 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

Uterine Prolapse; Pelvic Organ Prolapse Vaginal Surgery; Pelvic Organ Prolapse (POP)

Keywords

Uterine prolapse; Pelvic organ prolapse; Manchester procedure; Vaginal hysterectomy; Vaginal surgery

Outcome Measures

Primary Outcomes (1)

• Success at two year follow-up

  Success is defined as a composite outcome including 1. 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 2. 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 3. 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 Outcomes (19)

• Patient Global Impression of Improvement (PGI-I)

  1, 2, 5 and 10 year follow-up

• Patient Acceptable Symptom State (PASS)

  1, 2, 5 and 10 year follow-up

• Pelvic Floor Distress Inventory-20 (PFDI-20)

  1, 2, 5 and 10 year follow-up

• Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)

  1, 2, 5 and 10 year follow-up

• Generic health related quality of life measured by EuroQol-5D-5L

  1, 2, 5 and 10 year follow-up

Study Arms (2)

The Manchester procedure

EXPERIMENTAL

Procedure: Manchester procedure

Vaginal Hysterectomy

ACTIVE COMPARATOR

Procedure: Vaginal hysterectomy

Interventions

Manchester procedure 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.

Also known as: Fothergill's operation, Manchester-Fothergill procedure

The Manchester procedure

Vaginal hysterectomy PROCEDURE

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.

Vaginal Hysterectomy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 concurrent anterior or posterior compartment defects will be included.

You may not qualify if:

• Pregnancy or future plans of pregnancy
• Active malignancy of any kind
• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: collaborator
• Turku University Hospital: collaborator
• Kuopio University Hospital: collaborator
• Oulu University Hospital: collaborator
• Central Finland Central Hospital: collaborator
• Tampere University Hospital: lead

Study Sites (6)

Helsinki University Hospital

Helsinki, Finland

Location

Hospital Nova, The Wellbeing Services County of Central Finland

Jyväskylä, Finland

Location

Kuopio University Hospital

Kuopio, Finland

Location

Oulu University Hospital

Oulu, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Turku University Hospital

Turku, Finland

Location

MeSH Terms

Conditions

Uterine Prolapse; Pelvic Organ Prolapse

Interventions

Hysterectomy, Vaginal

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hysterectomy; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Päivi K Karjalainen, MD, PhD

CONTACT

+358142695512; paivi.karjalainen@hyvaks.fi

Anniina Karioja, MD

CONTACT

+358331165005; anniina.karioja@pirha.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The treatment groups will be coded as Group A and Group B during the analysis phase. Researchers will analyze the data and reach a consensus on the interpretation of results before the treatment codes are disclosed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: May 5, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): December 1, 2033
• Study Completion (Estimated): December 1, 2041
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

FI (6)