Pelvic Organ ProlapseNCT07411898
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.
An observational study of Pelvic Organ Prolapse and Pelvic Organ Prolapse Vaginal Surgery, run by Chung Shan Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Pelvic Organ Prolapse Vaginal Surgery, Pectopexy
- What is being tested?
- Laparoscopic pectopexy and Laparoscopic sacrocolpopexy
- Type of treatment
- Surgery or procedure
- How many people
- 67 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Aug 2020to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Presentation with a symptomatic uterine prolapse ≧ POP-Q stage 2 in patients who wished to retain the uterus
Who cannot join
- No known uterine or cervical pathology, no previous prolapse mesh repair, and no diseases known to affect bladder or bowel function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Laparoscopic pectopexy, Laparoscopic sacrocolpopexy
- Keywords
- Pelvic organ prolapse, Pectopexy, Sacrocolpopexy
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic pectopexyProcedure or surgery
Laparoscopic pectopexy with inverted T-mesh for concomitant apical and anterior vaginal wall prolapse repair
Laparoscopic sacrocolpopexyProcedure or surgery
Laparoscopic sacrocolpopexy with double mesh for pelvic organ prolapse repair
| Study group | Role | What they receive |
|---|---|---|
| Pectopexy | Laparoscopic pectopexy with inverted T-mesh for concomitant anterior and apical vaginal prolapse repair Receives: Procedure: Laparoscopic pectopexy | |
| Sacrocolpopexy | Laparoscopic sacrocolpopexy with double mesh for pelvic organ prolapse repair Receives: Procedure: Laparoscopic sacrocolpopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year post-operation
Secondary outcomes (2)
Rate of surgical complications
Complications arising from the hospital or operative course
Measured: 1 year post-operation
Rate of Reoperations
The number of reoperations that were needed due to the recurrence of pelvic organ prolapse found within 1 year post-operation
Measured: 1 year post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start26 Aug 2020
- Primary completion29 Apr 2024
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Man-Jung Hung, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411898
- Sponsor's protocol ID
- CSMUH No:CS2-21047
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29914258Chuang 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.
PubMed 34406417Akladios 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.
PubMed 20096499Grinstein 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.
PubMed 34125240Kotani 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.
PubMed 34909379Maher 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.
PubMed 37493538Yang 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;16(1):11202. doi: 10.1038/s41598-026-40730-0.
PubMed 41741609
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-year Outcomes of an Innovative Laparoscopic Pectopexy Procedure Using Inverted T-mesh for Treatment of Advanced Uterine and Anterior Vaginal Prolapse.
- ClinicalTrials.gov ID
- NCT07411898
- Acronym / sponsor ID
- CSMUH No:CS2-21047
- Keywords
- Pelvic organ prolapse, Pectopexy, Sacrocolpopexy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pectopexy | – | Procedure: Laparoscopic pectopexyLaparoscopic pectopexy with inverted T-mesh for concomitant anterior and apical vaginal prolapse repair |
| Sacrocolpopexy | – | Procedure: Laparoscopic sacrocolpopexyLaparoscopic sacrocolpopexy with double mesh for pelvic organ prolapse repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Presentation with a symptomatic uterine prolapse ≧ POP-Q stage 2 in patients who wished to retain the uterus
Key exclusion criteria (1 listed)
- No known uterine or cervical pathology, no previous prolapse mesh repair, and no diseases known to affect bladder or bowel function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic pectopexyLaparoscopic pectopexy with inverted T-mesh for concomitant apical and anterior vaginal wall prolapse repair | Procedure or surgery | Pectopexy |
| Laparoscopic sacrocolpopexyLaparoscopic sacrocolpopexy with double mesh for pelvic organ prolapse repair | Procedure or surgery | Sacrocolpopexy |
Primary outcome
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.
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.
2 secondary outcomes
Rate of surgical complications
Time frame: 1 year post-operation
Rate of Reoperations
Time frame: 1 year post-operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Background: PubMed 29914258Biler 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.
- Background: PubMed 34406417Chuang 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.
- Background: PubMed 20096499Akladios 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.
- Background: PubMed 34125240Grinstein 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.
- Background: PubMed 34909379Kotani 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.
- Background: PubMed 37493538Maher 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.
- Derived from this study: PubMed 41741609Yang 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;16(1):11202. doi: 10.1038/s41598-026-40730-0.
- Individual participant dataSharing planned: Undecided
Related trials for Pelvic Organ Prolapse
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse and Pelvic Organ Prolapse Vaginal Surgery, run by Chung Shan Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Organ Prolapse Anatomical Outcome (time frame: 1 year post-operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07411898, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.