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Search / Trial NCT06902909

Laparoscopic Pectopexy and Laparoscopic Colporrhaphies in Pelvic Organ Prolapse Treatment

Launched by TAMPERE UNIVERSITY HOSPITAL · Mar 24, 2025

Trial Information

Current as of November 08, 2025

Enrolling by invitation

Keywords

Laparoscopic Pectopexy Laparoscopic Colporraphy

ClinConnect Summary

This is a prospective observational study in Finland looking at how well laparoscopic pectopexy (with or without a nearby vaginal wall repair) works for pelvic organ prolapse. The main question is whether people still feel a bulge 12 months after surgery. Researchers will also track other symptoms, sexual function, bladder emptying, pain, quality of life, and safety, including how long the operation takes, blood loss, any complications, and how well the prolapse stays corrected, using a standard pelvic exam. Patients will complete several questionnaires before and after surgery, with follow-up at one year.

Eligible participants are women aged 18 to 79 who have symptomatic pelvic organ prolapse that reaches at least the hymenal ring and are suitable for laparoscopic mesh surgery. If the uterus is still in place, they must be willing to have a supracervical hysterectomy. Finnish language ability is required, and planning pregnancy is not. The study plans to enroll about 40–50 surgeries over about two years and is being done by a single experienced surgeon at two centers in Finland. No results are yet available, and individual participant data will not be shared publicly due to privacy rules.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Symptomatic pelvic organ prolapse
  • Uterine or vaginal vault prolapse reaching the hymenal ring (POP-Q classification: ≥0 cm)
  • If uterus in situ, consent for supracervical hysterectomy
  • Suitable for laparoscopic mesh surgery
  • Age: 18-79 years
  • Non-pregnant, no pregnancy desire.
  • Sufficient Finnish language skills
  • Concurrent anterior and/or posterior prolapse repair if POP-Q criteria met: tvl \>8 cm and Aa, Ba, Ap, Bp ≥0
  • Exclusion Criteria:
  • Unwillingness to undergo surgery or mesh implantation
  • High anesthetic or surgical risk due to comorbidities
  • Indication for laparoscopic sacrocolporectopexy due to rectal intussusception
  • Desire to preserve the uterus
  • Pregnancy or planning future pregnancy
  • Inability to understand Finnish or study-related forms due to cognitive impairments
  • Need for concomitant urinary incontinence surgery

About Tampere University Hospital

Tampere University Hospital (TAYS) is a leading academic medical center in Finland, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, TAYS integrates cutting-edge medical practices with rigorous scientific investigation, focusing on improving patient outcomes and enhancing treatment modalities across various specialties. The hospital collaborates with a network of researchers, healthcare professionals, and academic institutions to foster a multidisciplinary approach to medical research, ensuring that findings are translated into real-world applications for the benefit of patients and the broader healthcare community.

Locations

Seinäjoki, Finland

Patients applied

0 patients applied

Trial Officials

Kirsi Kuismanen, MD, PhD

Study Chair

Tampere University

Kari Nieminen, MD, PhD

Study Chair

Tampere University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported