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 | Active Not Recruiting

• 1 other identifier: CSMUH No:CS2-21047
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pelvic Organ Prolapse; Pelvic Organ Prolapse Vaginal Surgery; Pectopexy; Sacrocolpopexy

Keywords

Pelvic organ prolapse; Pectopexy; Sacrocolpopexy

Outcome Measures

Primary Outcomes (2)

• Pelvic Organ Prolapse Anatomical Outcome

  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

  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 Outcomes (2)

• Rate of surgical complications

  1 year post-operation

• Rate of Reoperations

  1 year post-operation

Study Arms (2)

Pectopexy

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

Procedure: Laparoscopic pectopexy

Sacrocolpopexy

Laparoscopic sacrocolpopexy with double mesh for pelvic organ prolapse repair

Procedure: Laparoscopic sacrocolpopexy

Interventions

Laparoscopic pectopexy PROCEDURE

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

Pectopexy

Laparoscopic sacrocolpopexy PROCEDURE

Laparoscopic sacrocolpopexy with double mesh for pelvic organ prolapse repair

Sacrocolpopexy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female with female pelvic organs
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Presentation with a symptomatic uterine prolapse ≧ POP-Q stage 2 in patients who wished to retain the uterus

You may not qualify if:

• No known uterine or cervical pathology, no previous prolapse mesh repair, and no diseases known to affect bladder or bowel function

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, 40201, Taiwan

Location

Related Publications (7)

• Biler A, Ertas IE, Tosun G, Hortu I, Demir A, Taner CE, Ozeren M, Sendag F. Perioperative complications and short-term outcomes of abdominal sacrocolpopexy, laparoscopic sacrocolpopexy, sacrospinous ligament fixation, and iliococcygeus fixation procedures. Turk J Med Sci. 2018 Jun 14;48(3):602-610. doi: 10.3906/sag-1712-203.

  PMID: 29914258 BACKGROUND

• Chuang FC, Chou YM, Wu LY, Yang TH, Chen WH, Huang KH. Laparoscopic pectopexy: the learning curve and comparison with laparoscopic sacrocolpopexy. Int Urogynecol J. 2022 Jul;33(7):1949-1956. doi: 10.1007/s00192-021-04934-4. Epub 2021 Aug 18.

  PMID: 34406417 BACKGROUND

• Akladios CY, Dautun D, Saussine C, Baldauf JJ, Mathelin C, Wattiez A. Laparoscopic sacrocolpopexy for female genital organ prolapse: establishment of a learning curve. Eur J Obstet Gynecol Reprod Biol. 2010 Apr;149(2):218-21. doi: 10.1016/j.ejogrb.2009.12.012. Epub 2010 Jan 21.

  PMID: 20096499 BACKGROUND

• Grinstein E, Abdelkhalek Y, Veit-Rubin N, Gluck O, Deval B. Long term outcomes of laparoscopic sacro/colpo-hysteropexy with and without rectopexy for the treatment of prolapse. Int Urogynecol J. 2022 Feb;33(2):343-350. doi: 10.1007/s00192-021-04868-x. Epub 2021 Jun 14.

  PMID: 34125240 BACKGROUND

• Kotani Y, Murakamsi K, Kai S, Yahata T, Kanto A, Matsumura N. Comparison of Surgical Results and Postoperative Recurrence Rates by Laparoscopic Sacrocolpopexy with Other Surgical Procedures for Managing Pelvic Organ Prolapse. Gynecol Minim Invasive Ther. 2021 Nov 5;10(4):221-225. doi: 10.4103/GMIT.GMIT_127_20. eCollection 2021 Oct-Dec.

  PMID: 34909379 BACKGROUND

• Maher C, Yeung E, Haya N, Christmann-Schmid C, Mowat A, Chen Z, Baessler K. Surgery for women with apical vaginal prolapse. Cochrane Database Syst Rev. 2023 Jul 26;7(7):CD012376. doi: 10.1002/14651858.CD012376.pub2.

  PMID: 37493538 BACKGROUND

• Yang E, Tsai CP, Shen PS, Ying TH, Lee TH, Chen GD, Liao YH, Hung MJ. One-year outcomes of an innovative laparoscopic pectopexy procedure using inverted T-mesh for treatment of advanced uterine and anterior vaginal prolapse. Sci Rep. 2026 Feb 26. doi: 10.1038/s41598-026-40730-0. Online ahead of print.

  PMID: 41741609 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Gynecological Minimally Invasive Therapy

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 17, 2026
• Study Start: August 26, 2020
• Primary Completion: April 29, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

TW (1)