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
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
426
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.
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.
Helsinki University Hospital
Helsinki, Finland
RECRUITINGHospital Nova, The Wellbeing Services County of Central Finland
Jyväskylä, Finland
RECRUITINGKuopio University Hospital
Kuopio, Finland
RECRUITINGOulu University Hospital
Oulu, Finland
RECRUITINGTampere University Hospital
Tampere, Finland
RECRUITINGTurku University Hospital
Turku, Finland
RECRUITINGSuccess 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-up
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-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)
Time frame: 1, 2, 5 and 10 year follow-up
Pelvic Floor Distress Inventory-20 (PFDI-20)
Questionnaire, 0 to 300, higher is worse
Time frame: 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
Time frame: 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
Time frame: 1, 2, 5 and 10 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.
Time frame: 2 and 5 year follow-up
Reoperation for pelvic organ prolapse
Proportion
Time frame: 1, 2, 5 and 10 years
Pessary treatment for pelvic organ prolapse or urinary incontinence
Proportion.
Time frame: 1, 2, 5 and 10 year follow-up
Further treatment for associated conditions
Proportion
Time frame: 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.
Time frame: From operation to two months
Operating time
Minutes
Time frame: Perioperative
Blood loss
ml
Time frame: Perioperative
Insertion of IUD
Yes/no (MP-group)
Time frame: Perioperative
Weight of uterus
VH-group, g
Time frame: Perioperative
Initiation of antithrombotic profylaxis
Yes/no
Time frame: Perioperative
Duration of hospitalization
Days spent in hospital, including the day of operation
Time frame: Days from operation to discharge, assessed at 1 year follow up
Duration of sick leave
Days, obtained from KELA registry
Time frame: 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
Time frame: 1, 2, 5 and 10 year follow-up
Success at five 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: Five year follow-up
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