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.

February 9, 2026 updated by: Man-Jung Hung, Chung Shan Medical University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 40201
        • Chung Shan Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women with a symptomatic uterine prolapse ≧ POP-Q stage 2 in patients who wished to retain the uterus and who were willing to undergo surgical pelvic organ prolapse repair.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pectopexy
Laparoscopic pectopexy with inverted T-mesh for concomitant anterior and apical vaginal prolapse repair
Procedure: Laparoscopic pectopexy
Laparoscopic pectopexy with inverted T-mesh for concomitant apical and anterior vaginal wall prolapse repair
Sacrocolpopexy
Laparoscopic sacrocolpopexy with double mesh for pelvic organ prolapse repair
Procedure: Laparoscopic sacrocolpopexy
Laparoscopic sacrocolpopexy with double mesh for pelvic organ prolapse repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year post-operation
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.
1 year post-operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of surgical complications
Time Frame: 1 year post-operation
Complications arising from the hospital or operative course
1 year post-operation
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
1 year post-operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung Shan Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2020

Primary Completion (Actual)

April 29, 2024

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 2, 2026

First Submitted That Met QC Criteria

February 9, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSMUH No:CS2-21047

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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