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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 April 23, 2025

Enrolling by invitation

Keywords

Laparoscopic Pectopexy Laparoscopic Colporraphy

ClinConnect Summary

The study aims to evaluate the effects of laparoscopic pectopexy and colporraphy on pelvic organ prolapse (POP) symptoms, anatomical prolapse repair, and surgical outcomes. The primary outcome measure is the presence of a bulging sensation 12 months after surgery. Secondary outcome measure includes additional prolapse-related symptoms, residual urine volume, pelvic pain, urinary incontinence, and safety parameters such as intraoperative blood loss and complications. Anatomical correction will be assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system.

All surgical procedures...

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

Trial Officials

Kirsi Kuismanen, MD, PhD

Study Chair

Tampere University

Kari Nieminen, MD, PhD

Study Chair

Tampere University

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported