Comparing the Manchester procedure versus vaginal hysterectomy for uterine prolapse

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Fin-UP trial randomly assigns women with symptomatic uterine prolapse to either the uterus-preserving Manchester procedure or to vaginal hysterectomy with apical suspension in a 1:1 parallel-group design. The primary outcome is a composite success measure at follow-up (no prolapse beyond the hymen, no bulge symptoms, and no retreatment). Secondary outcomes include anatomical results, pelvic floor symptoms, quality of life, sexual function, satisfaction, perioperative parameters, and adverse events. A total of 426 participants will be followed at 1, 2, 5, and 10 years to capture both short- and long-term outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: Päivi K Karjalainen, MD, PhD
• Email: paivi.karjalainen@hyvaks.fi
• Phone: +358142695512

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Vaginal versus robotic-assisted abdominal mesh repair for apical prolapse

  This study will test whether vaginal mesh repair works as well and is as safe as robotic-assisted abdominal mesh repair for women with stage II or higher apical pelvic organ prolapse.

  Recruiting University of Sao Paulo General Hospital · São Paulo, São Paulo · NCT07359755

• Wrist activity tracking to guide early recovery after pelvic organ prolapse surgery

  This study will try giving women having pelvic organ prolapse surgery either usual postoperative advice or a guided early-exercise plan while tracking activity with a wrist accelerometer to see which group reaches "mostly recovered" sooner.

  Recruiting at 6 sites NICHD Pelvic Floor Disorders Network · San Diego, California and 6 other locations · NCT07218016

• Deep muscle relaxation and a low-residue diet to improve the surgical view during vNOTES hysterectomy

  This trial tests whether a preoperative low-residue diet and deeper muscle relaxation help doctors see better during a vaginally performed hysterectomy for benign conditions.

  Recruiting Fatih Sultan Mehmet Training and Research Hospital · Istanbul, KARTAL and 2 other locations · NCT07730970

• Combined pelvic floor retraining and hypopressive exercises for uterine prolapse outcomes

  This study tests whether adding Hypopressive Exercises to Pelvic Floor Functional Movement Retraining helps improve pain, urinary symptoms, and quality of life for women with stage I-II uterine prolapse.

  Recruiting Riphah International University · Lahore, Punjab Province · NCT07642180

• Risk predictor for new urinary incontinence after prolapse surgery

  This study tests a model to predict which women might develop new stress urinary incontinence after pelvic organ prolapse repair.

  Recruiting Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Shanghai, Shanghai Municipality · NCT07601282

• Poly-L-lactic acid injections for vulvovaginal tissue regeneration

  This trial will try injections of poly-L-lactic acid (PLLA) versus placebo to see if they strengthen vaginal tissue and reduce bulge symptoms and sexual problems in women with stage II anterior vaginal wall prolapse (cystocele).

  Recruiting Duke University · Durham, North Carolina · NCT07544667

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.