The Finnish Uterine Prolapse Surgery Trial (The Fin-UP Trial)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-100
SponsorTampere University Hospital
About this 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Manchester procedure
Procedure/SurgeryThe 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 hysterectomy
Procedure/SurgeryThe 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.
Treatment groups
426 Participants
are divided into 2 treatment groupsGroup A: The Manchester procedureExperimental treatment 1 intervention
Group B: Vaginal HysterectomyActive comparator 1 intervention
Trial outcomes
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.
Time frame
Two year follow-upSecondary outcomes
1
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)
Time frame
1, 2, 5 and 10 year follow-up2
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)
Time frame
1, 2, 5 and 10 year follow-up3
Pelvic Floor Distress Inventory-20 (PFDI-20)
Questionnaire, 0 to 300, higher is worse
Time frame
1, 2, 5 and 10 year follow-up4
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
Questionnaire, 0 to 48, higher indicates better sexual function
Time frame
1, 2, 5 and 10 year follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tampere University Hospital
Lead sponsor
Helsinki University Central Hospital
Collaborator
Turku University Hospital
Collaborator
Kuopio University Hospital
Collaborator
Oulu University Hospital
Collaborator
Hospital Nova, Central Finland
Collaborator
Source ClinicalTrials.gov