Pelvic Organ ProlapsevnotesNCT07114029
VNOTES Approach in Mesh Free Sacrocolpopexy: A Functional and Anatomic Evaluation
A study testing Mesh-free Sacrocolpopexy via VNOTES in people with Pelvic Organ Prolapse, run by Gaziosmanpasa Research and Education Hospital at 2 sites in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effectiveness of mesh-free sacrocolpopexy performed using the VNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery) technique in the surgical treatment of pelvic organ prolapse. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Mesh-free Sacrocolpopexy via VNOTES
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 1 Jan 2026
- Phase
- Interventional
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who applied to Gaziosmanpasa Education and Research Hospital, Gynecology and Obstetrics Clinic, have apical and anterior POP Q stage 2 and above, and have undergone surgery due to symptomatic pelvic organ prolapse, Patients who are over the age of 18 and who are citizens of the Republic of Turkey, and who have undergone surgery by experienced surgeons will be included in the study.
Who cannot join
- Having previously received KT and/or RT due to any malignancy Having previously undergone surgery due to prolapse Patients with severe cardiovascular or respiratory diseases will not be included in the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Gaziosmanpaşa Training and Research Hospital
Istanbul
Havva Betül Bacak, Specialist, +905333610088, hbbacak90@gmail.com
Havva Betül Bacak, specialist
- Recruiting
Gaziosmanpaşa Training and Research Hospital
Istanbul
havva betül bacak, md, 5333610088, hbbacak90@gmail.com
About this study
Official title: Anatomic and Functional Comparison of Preoperative and Postoperative Outcomes of Mesh Free Sacrocolpopexy Performed Via Vaginal Natural Orifice Transluminal Endoscopic Surgery (VNOTES)
This study aims to evaluate the effectiveness of mesh-free sacrocolpopexy performed using the VNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery) technique in the surgical treatment of pelvic organ prolapse. Anatomical and functional outcomes will be assessed over a 6-month period before and after the operation. Evaluation tools will include the Pelvic Floor Distress Inventory-20 (PFDI-20), Pelvic Organ Prolapse Quantification (POP-Q) system, and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12).
The findings of this study are expected to provide important data on the anatomical improvement, functional outcomes, and impact on sexual function of mesh-free sacrocolpopexy performed via the VNOTES approach.
Read the detailed description
This prospective clinical study investigates the anatomical and functional outcomes of mesh-free sacrocolpopexy performed using the VNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery) technique in the surgical treatment of pelvic organ prolapse. The VNOTES approach allows transvaginal access to the pelvic cavity without the need for abdominal incisions, offering the advantages of minimally invasive surgery while avoiding the use of synthetic mesh.
The study includes women diagnosed with stage II or higher pelvic organ prolapse who are candidates for sacrocolpopexy via the VNOTES technique. All participants will undergo mesh-free sacrocolpopexy performed transvaginally using endoscopic guidance.
Anatomical and functional outcomes will be evaluated using validated tools, including the Pelvic Organ Prolapse Quantification (POP-Q) system, the Pelvic Floor Distress Inventory-20 (PFDI-20), and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Assessments will be performed preoperatively and at 6 months postoperatively. Intraoperative data such as operative time, estimated blood loss, complications, and length of hospital stay will also be collected.
The primary goal of the study is to assess anatomical success based on changes in POP-Q staging. Secondary outcomes include improvements in pelvic floor symptoms, sexual function, recurrence rates, and patient satisfaction.
This study aims to provide evidence on the safety, feasibility, and functional benefits of performing sacrocolpopexy without mesh through the VNOTES approach in the management of advanced pelvic organ prolapse.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Mesh-free Sacrocolpopexy via VNOTES
- Keywords
- sacrocolpopexy, mesh-free
- 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 Sacrocolpopexy via VNOTESProcedure or surgery
Mesh-free sacrocolpopexy is performed via the VNOTES technique to treat pelvic organ prolapse. Outcomes will be evaluated before and 6 months after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Mesh-free Sacrocolpopexy via VNOTES | Experimental | Mesh-free sacrocolpopexy is performed via the VNOTES technique to treat pelvic organ prolapse. Outcomes will be evaluated before and 6 months after surgery. Receives: Procedure: Mesh-free Sacrocolpopexy via VNOTES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Floor Distress Inventory-20 (PFDI-20) Score Change
Change in pelvic floor symptom distress measured by PFDI-20 questionnaire.
Measured: Baseline to 6 months postoperative
Pelvic Organ Prolapse Quantification (POP-Q) Score Change
Change in anatomical prolapse stage evaluated by POP-Q scoring system.
Measured: Baseline to 6 months postoperative
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) Score Change
Change in sexual function assessed by PISQ-12 questionnaire.
Measured: Baseline to 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Jul 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-arm, single-center interventional study designed to evaluate the anatomical and functional outcomes of mesh-free sacrocolpopexy performed via the VNOTES technique in patients with pelvic organ prolapse. All participants will undergo the same surgical intervention without randomization or a comparator arm. Preoperative and postoperative evaluations will be conducted using standardized tools over a 6-month follow-up period. The study is open-label, with no masking applied.
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- süleyman salman, professor, Study director, Gaziosmanpasa Training and Research Hospitalhavva betül bacak, md, Principal investigator, Gaziosmanpasa Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114029
- Sponsor's protocol ID
- gopvnotes
- Acronym
- vnotes
- Status last verified
- Aug 2025
- First submitted
- 10 Jul 2025
- Last updated
- 11 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 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomic and Functional Comparison of Preoperative and Postoperative Outcomes of Mesh Free Sacrocolpopexy Performed Via Vaginal Natural Orifice Transluminal Endoscopic Surgery (VNOTES)
- ClinicalTrials.gov ID
- NCT07114029
- Acronym / sponsor ID
- vnotes / gopvnotes
- Conditions
- Pelvic Organ Prolapse
- Keywords
- sacrocolpopexy, mesh-free
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 11 Aug 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 study aims to evaluate the effectiveness of mesh-free sacrocolpopexy performed using the VNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery) technique in the surgical treatment of pelvic organ prolapse. Anatomical and functional outcomes will be assessed over a 6-month period before and after the operation. Evaluation tools will include the Pelvic Floor Distress Inventory-20 (PFDI-20), Pelvic Organ Prolapse Quantification (POP-Q) system, and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12).
The findings of this study are expected to provide important data on the anatomical improvement, functional outcomes, and impact on sexual function of mesh-free sacrocolpopexy performed via the VNOTES approach.
Detailed description
This prospective clinical study investigates the anatomical and functional outcomes of mesh-free sacrocolpopexy performed using the VNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery) technique in the surgical treatment of pelvic organ prolapse. The VNOTES approach allows transvaginal access to the pelvic cavity without the need for abdominal incisions, offering the advantages of minimally invasive surgery while avoiding the use of synthetic mesh.
The study includes women diagnosed with stage II or higher pelvic organ prolapse who are candidates for sacrocolpopexy via the VNOTES technique. All participants will undergo mesh-free sacrocolpopexy performed transvaginally using endoscopic guidance.
Anatomical and functional outcomes will be evaluated using validated tools, including the Pelvic Organ Prolapse Quantification (POP-Q) system, the Pelvic Floor Distress Inventory-20 (PFDI-20), and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Assessments will be performed preoperatively and at 6 months postoperatively. Intraoperative data such as operative time, estimated blood loss, complications, and length of hospital stay will also be collected.
The primary goal of the study is to assess anatomical success based on changes in POP-Q staging. Secondary outcomes include improvements in pelvic floor symptoms, sexual function, recurrence rates, and patient satisfaction.
This study aims to provide evidence on the safety, feasibility, and functional benefits of performing sacrocolpopexy without mesh through the VNOTES approach in the management of advanced pelvic organ prolapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-arm, single-center interventional study designed to evaluate the anatomical and functional outcomes of mesh-free sacrocolpopexy performed via the VNOTES technique in patients with pelvic organ prolapse. All participants will undergo the same surgical intervention without randomization or a comparator arm. Preoperative and postoperative evaluations will be conducted using standardized tools over a 6-month follow-up period. The study is open-label, with no masking applied.
| Arm | Type | Receives |
|---|---|---|
| Mesh-free Sacrocolpopexy via VNOTES | Experimental | Procedure: Mesh-free Sacrocolpopexy via VNOTESMesh-free sacrocolpopexy is performed via the VNOTES technique to treat pelvic organ prolapse. Outcomes will be evaluated before and 6 months after surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who applied to Gaziosmanpasa Education and Research Hospital, Gynecology and Obstetrics Clinic, have apical and anterior POP Q stage 2 and above, and have undergone surgery due to symptomatic pelvic organ prolapse, Patients who are over the age of 18 and who are citizens of the Republic of Turkey, and who have undergone surgery by experienced surgeons will be included in the study.
Key exclusion criteria (1 listed)
- Having previously received KT and/or RT due to any malignancy Having previously undergone surgery due to prolapse Patients with severe cardiovascular or respiratory diseases will not be included in the study.
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 Sacrocolpopexy via VNOTESMesh-free sacrocolpopexy is performed via the VNOTES technique to treat pelvic organ prolapse. Outcomes will be evaluated before and 6 months after surgery. | Procedure or surgery | Mesh-free Sacrocolpopexy via VNOTES |
Primary outcome
Pelvic Floor Distress Inventory-20 (PFDI-20) Score Change
Time frame: Baseline to 6 months postoperative
Change in pelvic floor symptom distress measured by PFDI-20 questionnaire.
Pelvic Organ Prolapse Quantification (POP-Q) Score Change
Time frame: Baseline to 6 months postoperative
Change in anatomical prolapse stage evaluated by POP-Q scoring system.
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) Score Change
Time frame: Baseline to 6 months postoperative
Change in sexual function assessed by PISQ-12 questionnaire.
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 11 Aug 2025.
- Individual participant dataSharing planned: No
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
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i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
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Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
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Pelvic Floor Muscle Training During Pregnancy
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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.
süleyman salman, professor study director
Gaziosmanpasa Training and Research Hospital
havva betül bacak, md principal investigator
Gaziosmanpasa Training and Research Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mesh-free Sacrocolpopexy via VNOTES in people with Pelvic Organ Prolapse, run by Gaziosmanpasa Research and Education Hospital at 2 sites 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 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: looking for participants now, as of the sponsor's last update on 11 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 2 sites 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?
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?
Contact yağmur acıyiyen, md (+905425669593, yagmuraciyiyen95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Floor Distress Inventory-20 (PFDI-20) Score Change (time frame: Baseline to 6 months postoperative). The study lists 3 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 11 Aug 2025.