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

Official title

Manchester Procedure Versus Vaginal Hysterectomy for Women With Uterine Prolapse: A Multi-Center Randomized Controlled Study (The Fin-UP Trial)

Overview

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

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.

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 a
• 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 passe

Primary outcome measures

• Success at two year follow-up [Time frame: Two year follow-up]

Secondary outcome measures (12)

• Patient Global Impression of Improvement (PGI-I) [Time frame: 1, 2, 5 and 10 year follow-up]
• Patient Acceptable Symptom State (PASS) [Time frame: 1, 2, 5 and 10 year follow-up]
• Pelvic Floor Distress Inventory-20 (PFDI-20) [Time frame: 1, 2, 5 and 10 year follow-up]
• Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) [Time frame: 1, 2, 5 and 10 year follow-up]
• Generic health related quality of life measured by EuroQol-5D-5L [Time frame: 1, 2, 5 and 10 year follow-up]
• Pelvic Organ Prolapse Quantification System (POP-Q) [Time frame: 2 and 5 year follow-up]
• Reoperation for pelvic organ prolapse [Time frame: 1, 2, 5 and 10 years]
• Pessary treatment for pelvic organ prolapse or urinary incontinence [Time frame: 1, 2, 5 and 10 year follow-up]
• Further treatment for associated conditions [Time frame: 1, 2, 5 and 10 year follow-up]
• Adverse events [Time frame: From operation to two months]
• Operating time [Time frame: Perioperative]
• Blood loss [Time frame: Perioperative]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Finland · 6 centers

• Helsinki University Hospital — Helsinki
• Hospital Nova, The Wellbeing Services County of Central Finland — Jyväskylä
• Kuopio University Hospital — Kuopio
• Oulu University Hospital — Oulu
• Tampere University Hospital — Tampere
• Turku University Hospital — Turku

Identifiers

NCT: NCT07566949 · R25060

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗