Pelvic Organ Prolapse (POP), Pelvic Organ Prolapse Vaginal Surgery, Uterine Prolapse
Conditions
Keywords
Uterine prolapse, Pelvic organ prolapse, Manchester procedure, Vaginal hysterectomy, Vaginal surgery
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
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
PROCEDUREManchester 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.
PROCEDUREVaginal 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
Tampere University Hospital
Helsinki University Central Hospital
Turku University Hospital
Kuopio University Hospital
Oulu University Hospital
Hospital Nova, Central Finland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success at two year follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Improvement (PGI-I) | 1, 2, 5 and 10 year follow-up | 7 step Likert scale (Much better - somewhat better - a little better - no change - a little worse - somewhat worse - much worse) |
| Patient Acceptable Symptom State (PASS) | 1, 2, 5 and 10 year follow-up | Defined by the question "When taking into account all your symptoms related to prolapse, do you consider your current state good enough?" (yes/no) |
| Pelvic Floor Distress Inventory-20 (PFDI-20) | 1, 2, 5 and 10 year follow-up | Questionnaire, 0 to 300, higher is worse |
| Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) | 1, 2, 5 and 10 year follow-up | Questionnaire, 0 to 48, higher indicates better sexual function |
| Generic health related quality of life measured by EuroQol-5D-5L | 1, 2, 5 and 10 year follow-up | Questionnaire, 0 to 1, higher is better |
| Pelvic Organ Prolapse Quantification System (POP-Q) | 2 and 5 year follow-up | 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. |
| Reoperation for pelvic organ prolapse | 1, 2, 5 and 10 years | Proportion |
| Pessary treatment for pelvic organ prolapse or urinary incontinence | 1, 2, 5 and 10 year follow-up | Proportion. |
| Further treatment for associated conditions | 1, 2, 5 and 10 year follow-up | Proportion |
| Adverse events | From operation to two months | 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. |
| Operating time | Perioperative | Minutes |
| Blood loss | Perioperative | ml |
| Insertion of IUD | Perioperative | Yes/no (MP-group) |
| Weight of uterus | Perioperative | VH-group, g |
| Initiation of antithrombotic profylaxis | Perioperative | Yes/no |
| Duration of hospitalization | Days from operation to discharge, assessed at 1 year follow up | Days spent in hospital, including the day of operation |
| Duration of sick leave | From operation to last day of sick leave, assessed at 1 year follow-up | Days, obtained from KELA registry |
| Long term complications | 1, 2, 5 and 10 year follow-up | 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 |
| Success at five year follow-up | 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. |
Countries
Finland
Contacts
CONTACTPäivi K Karjalainen, MD, PhD
CONTACTAnniina Karioja, MD
Outcome results
None listed