An interventional study of Manchester procedure and Vaginal hysterectomy in Uterine Prolapse, Pelvic Organ Prolapse Vaginal Surgery and Pelvic Organ Prolapse (POP), sponsored by Tampere University Hospital. Recruiting at 6 sites in Finland. Open to female participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by Tampere University Hospital · Not applicable, Interventional, and Treatment
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:
Participants will:
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.
111 studies on the registry are indexed under Uterine Prolapse; 18 are open to participants now.
This study's planned enrollment of 426 is above the median of 70 across 76 interventional studies indexed under Uterine Prolapse.
Browse Uterine Prolapse studies →Tampere University Hospital is the lead sponsor of 212 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Manchester procedure
Procedure: Vaginal hysterectomy
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.
Also known as: Fothergill's operation, Manchester-Fothergill procedure
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.
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-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
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for May 2026; primary completion for Dec 2033, 91 months later.
Of 37 interventional studies with no phase under Uterine Prolapse, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 68. This study's planned 91 months is above that.
How these figures are worked out, and which studies are left out of them.
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