Pelvic Organ ProlapsePectoMeshNCT07080957
Comparison of Mesh-Based and Mesh-Free Laparoscopic Pectopexy in Uterus-Preserving Surgery for Apical Prolapse
A study testing Mesh-free laparoscopic uterus-preserving pectopexy and Mesh-based laparoscopic uterus-preserving pectopexy in people with Pelvic Organ Prolapse, run by Havva Betül Bacak at 1 site in Turkey (Türkiye).
Trial summary
This retrospective cohort study compares anatomical and functional outcomes of mesh-based and mesh-free laparoscopic uterus-preserving pectopexy in women with apical pelvic organ prolapse. A total of 81 patients were included between 2021 and 2024 (mesh-based: 41, mesh-free: 40). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Mesh-free laparoscopic uterus-preserving pectopexy and Mesh-based laparoscopic uterus-preserving pectopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Apr 2025to 14 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of pelvic organ prolapse (POP) classified as stage 2 or higher according to the POP-Q (Pelvic Organ Prolapse Quantification) system
- Desire for uterus preservation and refusal of hysterectomy during surgery
- Eligible for surgical intervention and able to undergo general anesthesia
- Women aged 18 years and older with pelvic organ prolapse
Who cannot join
- History of hysterectomy
- Severe comorbidities (e.g., serious cardiovascular diseases, bleeding disorders, or other medical conditions that may interfere with surgical treatment)
- Active infections in the pelvic or urogenital region
- Advanced malignancies (e.g., cancer)
- Psychological or cognitive impairments preventing informed consent or compliance with postoperative follow-up
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpaşa Training and Research Hospital
Istanbul
About this study
Official title: Comparative Outcomes of Mesh-Based and Mesh-Free Laparoscopic Uterus-Preserving Pectopexy for Apical Prolapse: A Retrospective Cohort Study
This retrospective cohort study compares anatomical and functional outcomes of mesh-based and mesh-free laparoscopic uterus-preserving pectopexy in women with apical pelvic organ prolapse. A total of 81 patients were included between 2021 and 2024 (mesh-based: 41, mesh-free: 40). Key outcomes assessed included operative time, blood loss, hospital stay, anatomical correction (POP-Q), sexual function (PISQ-12), and complications. Both techniques significantly improved prolapse and sexual function. Mesh-based pectopexy offered superior apical and posterior support, while mesh-free pectopexy was associated with longer vaginal length and longer operative time. Complication and recurrence rates were low and similar across groups. The findings suggest that both techniques are effective, and surgical approach should be tailored to patient preference and clinical context.
Read the detailed description
This retrospective cohort study was conducted to compare the anatomical and functional outcomes of mesh-based and mesh-free laparoscopic uterus-preserving pectopexy in the treatment of apical pelvic organ prolapse (POP). POP is a common condition among women, particularly those over 50 years of age, characterized by the descent of pelvic organs into the vaginal canal. While mesh-based procedures are known to offer robust apical support, they are associated with long-term complications such as mesh erosion, infection, and chronic pelvic pain. In contrast, mesh-free techniques may offer a safer alternative, particularly for patients wishing to avoid synthetic implants.
A total of 81 patients who underwent laparoscopic pectopexy between 2021 and 2024 at a tertiary care institution were included. Patients were divided into two groups based on the use of mesh: 41 underwent mesh-based and 40 underwent mesh-free procedures. Preoperative and postoperative assessments were conducted using the POP-Q (Pelvic Organ Prolapse Quantification) system for anatomical staging and the PISQ-12 (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire) for evaluating sexual function. Operative time, estimated blood loss, length of hospital stay, postoperative complications, and recurrence rates were also analyzed. Follow-up evaluations were scheduled at 6 weeks, 3 months, and 1 year.
The study found that both techniques significantly improved anatomical support and sexual function. Mesh-based pectopexy provided better apical and posterior compartment support, while the mesh-free approach resulted in a longer vaginal length and was preferred by patients seeking to avoid mesh-related complications. Operative time was significantly longer in the mesh-free group. Complication and recurrence rates were low and comparable between groups.
This study contributes to the growing body of evidence supporting uterus-preserving surgical options in POP treatment and highlights the importance of individualized surgical planning based on patient needs, preferences, and clinical profiles.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Mesh-free laparoscopic uterus-preserving pectopexy, Mesh-based laparoscopic uterus-preserving pectopexy
- Keywords
- Laparoscopic Pectopexy, Apical Prolapse
- 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.
Mesh-free laparoscopic uterus-preserving pectopexyProcedure or surgery
Laparoscopic pectopexy without synthetic mesh was performed by utilizing native tissue fixation techniques. The uterus was suspended to the iliopectineal ligaments using permanent sutures without mesh implantation. The procedure aimed to provide apical support and avoid mesh-related complications. Postoperative follow-up included assessments of anatomical correction, functional recovery, and patient satisfaction.
Mesh-based laparoscopic uterus-preserving pectopexyProcedure or surgery
Laparoscopic pectopexy was performed using a synthetic mesh to provide apical support while preserving the uterus. The mesh was bilaterally fixed to the iliopectineal (Cooper's) ligaments, and the uterus was suspended in a tension-free manner. This technique is designed to restore pelvic anatomy and improve symptoms of prolapse. Patients were followed postoperatively to assess anatomical success, complications, and functional outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Mesh-free laparoscopic uterus-preserving pectopexy | Active comparator | Patients in this group underwent laparoscopic uterus-preserving pectopexy without the use of synthetic mesh. Instead, native tissue fixation techniques were employed to achieve apical support. The uterus was preserved in all cases. Follow-up was conducted at 6 weeks, 3 months, and 1 year to evaluate outcomes. Receives: Procedure: Mesh-free laparoscopic uterus-preserving pectopexy |
| Mesh-based laparoscopic uterus-preserving pectopexy | Active comparator | Patients in this group underwent laparoscopic uterus-preserving pectopexy using synthetic mesh for apical support. The mesh was fixed bilaterally to the iliopectineal ligaments to restore apical support while preserving the uterus. Outcomes were assessed preoperatively and at 6 weeks, 3 months, and 1 year postoperatively. Receives: Procedure: Mesh-based laparoscopic uterus-preserving pectopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical Success According to POP-Q System
Anatomical success is defined as apical pelvic support at stage 0 or I according to the Pelvic Organ Prolapse Quantification (POP-Q) system. Specific points evaluated include C (cervix or vaginal cuff), D (posterior fornix if applicable), Ba, Bp, and TVL (total vaginal length). Success indicates restored apical support without need for additional surgical intervention or evidence of recurrence at 1-year follow-up.
Measured: 1 year postoperatively
Change in Sexual Function Based on PISQ-12 Score
Sexual function was evaluated using the validated Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Scores range from 0 to 48, with higher scores indicating better sexual function. The primary endpoint was the change in total PISQ-12 score from baseline (preoperative) to 1 year postoperative. Improvements were compared between the mesh-based and mesh-free pectopexy groups to assess functional recovery related to sexual health.
Measured: Baseline to 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start16 Apr 2025
- Primary completion14 Jul 2025
- Study completion14 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center, retrospective cohort study designed to compare two surgical techniques-mesh-based and mesh-free laparoscopic uterus-preserving pectopexy-in patients diagnosed with apical pelvic organ prolapse. Data were collected from medical records of patients operated between 2021 and 2024. Participants were divided into two groups based on the type of surgical procedure received. Outcomes including anatomical correction, sexual function, operative time, complications, and recurrence were assessed using standardized instruments such as the POP-Q system and the PISQ-12 questionnaire. No randomization or blinding was applied due to the retrospective nature of the study.
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Havva Betül Bacak
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Havva Betül Bacak, Gaziosmanpasa Research and Education Hospital
- Investigators
- enes serhat coşkun, md, Study chair, University of Health Sciences, Gaziosmanpaşa Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080957
- Sponsor's protocol ID
- gopMeshBasedMeshFreepecto
- Acronym
- PectoMesh
- Status last verified
- Aug 2025
- First submitted
- 15 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Outcomes of Mesh-Based and Mesh-Free Laparoscopic Uterus-Preserving Pectopexy for Apical Prolapse: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07080957
- Acronym / sponsor ID
- PectoMesh / gopMeshBasedMeshFreepecto
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Laparoscopic Pectopexy, Apical Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Havva Betül BacakOther government
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 23 Jul 2025 (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.
This retrospective cohort study compares anatomical and functional outcomes of mesh-based and mesh-free laparoscopic uterus-preserving pectopexy in women with apical pelvic organ prolapse. A total of 81 patients were included between 2021 and 2024 (mesh-based: 41, mesh-free: 40). Key outcomes assessed included operative time, blood loss, hospital stay, anatomical correction (POP-Q), sexual function (PISQ-12), and complications. Both techniques significantly improved prolapse and sexual function. Mesh-based pectopexy offered superior apical and posterior support, while mesh-free pectopexy was associated with longer vaginal length and longer operative time. Complication and recurrence rates were low and similar across groups. The findings suggest that both techniques are effective, and surgical approach should be tailored to patient preference and clinical context.
Detailed description
This retrospective cohort study was conducted to compare the anatomical and functional outcomes of mesh-based and mesh-free laparoscopic uterus-preserving pectopexy in the treatment of apical pelvic organ prolapse (POP). POP is a common condition among women, particularly those over 50 years of age, characterized by the descent of pelvic organs into the vaginal canal. While mesh-based procedures are known to offer robust apical support, they are associated with long-term complications such as mesh erosion, infection, and chronic pelvic pain. In contrast, mesh-free techniques may offer a safer alternative, particularly for patients wishing to avoid synthetic implants.
A total of 81 patients who underwent laparoscopic pectopexy between 2021 and 2024 at a tertiary care institution were included. Patients were divided into two groups based on the use of mesh: 41 underwent mesh-based and 40 underwent mesh-free procedures. Preoperative and postoperative assessments were conducted using the POP-Q (Pelvic Organ Prolapse Quantification) system for anatomical staging and the PISQ-12 (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire) for evaluating sexual function. Operative time, estimated blood loss, length of hospital stay, postoperative complications, and recurrence rates were also analyzed. Follow-up evaluations were scheduled at 6 weeks, 3 months, and 1 year.
The study found that both techniques significantly improved anatomical support and sexual function. Mesh-based pectopexy provided better apical and posterior compartment support, while the mesh-free approach resulted in a longer vaginal length and was preferred by patients seeking to avoid mesh-related complications. Operative time was significantly longer in the mesh-free group. Complication and recurrence rates were low and comparable between groups.
This study contributes to the growing body of evidence supporting uterus-preserving surgical options in POP treatment and highlights the importance of individualized surgical planning based on patient needs, preferences, and clinical profiles.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single-center, retrospective cohort study designed to compare two surgical techniques-mesh-based and mesh-free laparoscopic uterus-preserving pectopexy-in patients diagnosed with apical pelvic organ prolapse. Data were collected from medical records of patients operated between 2021 and 2024. Participants were divided into two groups based on the type of surgical procedure received. Outcomes including anatomical correction, sexual function, operative time, complications, and recurrence were assessed using standardized instruments such as the POP-Q system and the PISQ-12 questionnaire. No randomization or blinding was applied due to the retrospective nature of the study.
| Arm | Type | Receives |
|---|---|---|
| Mesh-free laparoscopic uterus-preserving pectopexy | Active comparator | Procedure: Mesh-free laparoscopic uterus-preserving pectopexyPatients in this group underwent laparoscopic uterus-preserving pectopexy without the use of synthetic mesh. Instead, native tissue fixation techniques were employed to achieve apical support. The uterus was preserved in all cases. Follow-up was conducted at 6 weeks, 3 months, and 1 year to evaluate outcomes. |
| Mesh-based laparoscopic uterus-preserving pectopexy | Active comparator | Procedure: Mesh-based laparoscopic uterus-preserving pectopexyPatients in this group underwent laparoscopic uterus-preserving pectopexy using synthetic mesh for apical support. The mesh was fixed bilaterally to the iliopectineal ligaments to restore apical support while preserving the uterus. Outcomes were assessed preoperatively and at 6 weeks, 3 months, and 1 year postoperatively. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of pelvic organ prolapse (POP) classified as stage 2 or higher according to the POP-Q (Pelvic Organ Prolapse Quantification) system
- Desire for uterus preservation and refusal of hysterectomy during surgery
- Eligible for surgical intervention and able to undergo general anesthesia
- Women aged 18 years and older with pelvic organ prolapse
Key exclusion criteria (5 listed)
- History of hysterectomy
- Severe comorbidities (e.g., serious cardiovascular diseases, bleeding disorders, or other medical conditions that may interfere with surgical treatment)
- Active infections in the pelvic or urogenital region
- Advanced malignancies (e.g., cancer)
- Psychological or cognitive impairments preventing informed consent or compliance with postoperative follow-up
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 |
|---|---|---|
| Mesh-free laparoscopic uterus-preserving pectopexyLaparoscopic pectopexy without synthetic mesh was performed by utilizing native tissue fixation techniques. The uterus was suspended to the iliopectineal ligaments using permanent sutures without mesh implantation. The procedure aimed to provide apical support and avoid mesh-related complications. Postoperative follow-up included assessments of anatomical correction, functional recovery, and patient satisfaction. | Procedure or surgery | Mesh-free laparoscopic uterus-preserving pectopexy |
| Mesh-based laparoscopic uterus-preserving pectopexyLaparoscopic pectopexy was performed using a synthetic mesh to provide apical support while preserving the uterus. The mesh was bilaterally fixed to the iliopectineal (Cooper's) ligaments, and the uterus was suspended in a tension-free manner. This technique is designed to restore pelvic anatomy and improve symptoms of prolapse. Patients were followed postoperatively to assess anatomical success, complications, and functional outcomes. | Procedure or surgery | Mesh-based laparoscopic uterus-preserving pectopexy |
Primary outcome
Anatomical Success According to POP-Q System
Time frame: 1 year postoperatively
Anatomical success is defined as apical pelvic support at stage 0 or I according to the Pelvic Organ Prolapse Quantification (POP-Q) system. Specific points evaluated include C (cervix or vaginal cuff), D (posterior fornix if applicable), Ba, Bp, and TVL (total vaginal length). Success indicates restored apical support without need for additional surgical intervention or evidence of recurrence at 1-year follow-up.
Change in Sexual Function Based on PISQ-12 Score
Time frame: Baseline to 1 year postoperatively
Sexual function was evaluated using the validated Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Scores range from 0 to 48, with higher scores indicating better sexual function. The primary endpoint was the change in total PISQ-12 score from baseline (preoperative) to 1 year postoperative. Improvements were compared between the mesh-based and mesh-free pectopexy groups to assess functional recovery related to sexual health.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No
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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.
enes serhat coşkun, md study chair
University of Health Sciences, Gaziosmanpaşa Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mesh-free laparoscopic uterus-preserving pectopexy and Mesh-based laparoscopic uterus-preserving pectopexy in people with Pelvic Organ Prolapse, run by Havva Betül Bacak at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 5 Aug 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Anatomical Success According to POP-Q System (time frame: 1 year postoperatively). 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?
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 5 Aug 2025.