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

Interventions

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.

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.

Sponsors & Collaborators

• Helsinki University Central Hospital

  collaborator OTHER

• Turku University Hospital

  collaborator OTHER_GOV

• Kuopio University Hospital

  collaborator OTHER

• Oulu University Hospital

  collaborator OTHER

• Hospital Nova, Central Finland

  collaborator OTHER

• Tampere University Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-31

Primary Completion

2033-12-31

Completion

2041-12-31

Countries

• Finland

Study Locations