Ireland
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Active, not recruiting Observational

To Explore the Surgical Outcomes and Safety of an Innovative Laparoscopic Uterine Pectopexy Technique Using Inverted T-meshes for Simultaneous Apical and Anterior Vaginal Repair.

NCT07411898 · tracked via the Priya Life Science Taiwan tracker
Phase
Observational
Started
2020-08-26
Last updated
2026-02-17

Condition(s) studied

Pelvic Organ ProlapsePelvic Organ Prolapse Vaginal SurgeryPectopexySacrocolpopexy

Investigational drug(s) / intervention(s)

Laparoscopic pectopexyLaparoscopic sacrocolpopexy

Laparoscopic pectopexy: Laparoscopic pectopexy with inverted T-mesh for concomitant apical and anterior vaginal wall prolapse repair

Laparoscopic sacrocolpopexy: Laparoscopic sacrocolpopexy with double mesh for pelvic organ prolapse repair

Study summary

Patients referred for pelvic reconstructive surgery frequently present with combined anterior and apical vaginal wall prolapse. Previous studies found that anterior compartment involvement is the most common and serious defect that occurs with an apical defect. To address this, many surgeons will conduct concomitant surgeries in addition to sacrocolpopexy or pectopexy. This prospective pilot study was conducted to explore the surgical outcomes and safety of an innovative laparoscopic uterine pectopexy technique using inverted T-meshes for simultaneous apical and anterior vaginal repair.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Presentation with a symptomatic uterine prolapse ≧ POP-Q stage 2 in patients who wished to retain the uterus Exclusion Criteria: * No known uterine or cervical pathology, no previous prolapse mesh repair, and no diseases known to affect bladder or bowel function

Primary outcome measure(s)

  • Pelvic Organ Prolapse Anatomical Outcome — 1 year post-operation
    Anatomic outcomes were assessed by evaluating the pre- and post-operative prolapse stages as evaluated by the Pelvic Organ Prolapse Quantification (POP-Q) system. The plane of the hymen was defined as zero, all measures are in centimeters proximal (negative number) and distal (positive number) to the hymen. The more positive the number, the more severe the prolapse.
  • Rate of distress caused by pelvic floor symptoms — 1 year post-operation
    These outcomes were assessed pre- and post-operation via the Pelvic Floor Distress Inventory (PFDI-20) questionnaire. Higher scores indicated greater symptom distress.

Trial sites (1)

FacilityCityRegionStatus
Chung Shan Medical University Hospital Taichung Taiwan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07411898 on ClinicalTrials.gov ↗ ← All trials in Taiwan