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NCT Number: NCT07411898

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.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pectopexy Pelvic Organ Prolapse Vaginal Surgery Prolapse Sacrocolpopexy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Chung Shan Medical University Hospital

Taichung, 40201, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic Pectopexy

Procedure

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

Laparoscopic sacrocolpopexy

Procedure

Laparoscopic sacrocolpopexy with double mesh for pelvic organ prolapse repair

Primary outcomes

  1. Pelvic Organ Prolapse Anatomical Outcome

    Time frame: 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.

  2. Rate of distress caused by pelvic floor symptoms

    Time frame: 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.

Secondary outcomes

  1. Rate of surgical complications

    Time frame: 1 year post-operation

    Complications arising from the hospital or operative course

  2. Rate of Reoperations

    Time frame: 1 year post-operation

    The number of reoperations that were needed due to the recurrence of pelvic organ prolapse found within 1 year post-operation

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Official study title

One-year Outcomes of an Innovative Laparoscopic Pectopexy Procedure Using Inverted T-mesh for Treatment of Advanced Uterine and Anterior Vaginal Prolapse.

Important dates

Study start
2020
Primary completion
2024
Study completion
2026
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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