Pelvic Organ ProlapsevnotesNCT07082023
Comparison of V-NOTES and Laparoscopic Mesh-Free Sacrocolpopexy Techniques
A study testing V-NOTES Mesh-Free Sacrocolpopexy and Laparoscopic Mesh-Free Sacrocolpopexy in people with Pelvic Organ Prolapse, run by Havva Betül Bacak at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the surgical outcomes, safety profiles, and patient satisfaction between two minimally invasive techniques for pelvic organ prolapse repair: Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) mesh-free sacrocolpopexy and laparoscopic mesh-free sacrocolpopexy. 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?
- V-NOTES Mesh-Free Sacrocolpopexy and Laparoscopic Mesh-Free Sacrocolpopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (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 Gaziosmanpaşa Education and Research Hospital, Gynecology and Obstetrics Clinic, who underwent surgery due to symptomatic pelvic organ prolapse with apical and anterior POP Q stage 2 and above, Being over 18 years old Patients who underwent surgery by experienced surgeons
Who cannot join
- Having previously received KT and/or RT due to any malignancy Having previously undergone surgery due to proplasus Patients with severe cardiovascular or respiratory disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziosmanpasa Training and Research Hospital
Istanbul
süleyman salman, +905059345470, slymnsalman@gmail.com
yağmur md acıyiyen
About this study
Official title: Comparison of V-NOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery) Mesh-Free Sacrocolpopexy and Laparoscopic Mesh-Free Sacrocolpopexy
This study aims to compare the surgical outcomes, safety profiles, and patient satisfaction between two minimally invasive techniques for pelvic organ prolapse repair: Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) mesh-free sacrocolpopexy and laparoscopic mesh-free sacrocolpopexy. By evaluating perioperative data, complication rates, anatomical and functional outcomes, this trial seeks to determine whether the V-NOTES approach provides comparable or superior results to the traditional laparoscopic technique, without the use of synthetic mesh.
Read the detailed description
Pelvic organ prolapse (POP) is a common condition among women, especially with increasing age and parity, often requiring surgical intervention. Sacrocolpopexy is considered the gold standard for apical prolapse repair due to its high anatomical success rate and long-term durability. Traditionally performed via open or laparoscopic approaches, sacrocolpopexy has evolved with minimally invasive techniques.
Recently, mesh-related complications have led to a growing interest in mesh-free alternatives. Simultaneously, natural orifice approaches such as Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) have gained popularity due to better cosmetic results, reduced postoperative pain, and faster recovery times.
This prospective, comparative study aims to evaluate and compare the clinical outcomes of mesh-free sacrocolpopexy performed via V-NOTES versus the laparoscopic approach. Parameters including operative time, intraoperative and postoperative complications, hospital stay, pain scores, anatomical success, and patient satisfaction will be analyzed. The goal is to assess whether V-NOTES can be a safe and effective alternative to laparoscopic mesh-free sacrocolpopexy in the surgical management of POP.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- V-NOTES Mesh-Free Sacrocolpopexy, Laparoscopic Mesh-Free Sacrocolpopexy
- Keywords
- Sacrocolpopexy, vNOTES
- 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.
V-NOTES Mesh-Free SacrocolpopexyProcedure or surgery
Mesh-free sacrocolpopexy performed via vaginal natural orifice transluminal endoscopic surgery (V-NOTES).
Laparoscopic Mesh-Free SacrocolpopexyProcedure or surgery
Mesh-free sacrocolpopexy performed via conventional laparoscopy.
| Study group | Role | What they receive |
|---|---|---|
| V-NOTES Sacrocolpopexy | Experimental | Patients undergoing mesh-free sacrocolpopexy via vaginal natural orifice transluminal endoscopic surgery (V-NOTES). Receives: Procedure: V-NOTES Mesh-Free Sacrocolpopexy |
| Laparoscopic Sacrocolpopexy | Active comparator | Patients undergoing mesh-free sacrocolpopexy via conventional laparoscopy. Receives: Procedure: Laparoscopic Mesh-Free Sacrocolpopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pelvic Organ Prolapse Quantification (POP-Q) stage from baseline to 6 months
Anatomical success will be evaluated using the POP-Q system. A reduction of prolapse stage by at least one level or achieving stage 0-1 will be considered successful.
Measured: Baseline and 6 months postoperative
Change in PISQ-12 Score
Sexual function will be evaluated with PISQ-12. An increase in score indicates improvement.
Measured: Baseline and 6 months postoperative
Change in Pelvic Floor Distress Inventory-20 (PFDI-20) Score
Patient-reported symptoms related to pelvic floor distress will be evaluated using the PFDI-20. A decrease in score indicates improvement in symptoms.
Measured: Baseline and 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 posted24 Jul 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, interventional, randomized, parallel-group clinical trial comparing two minimally invasive surgical techniques for pelvic organ prolapse repair: V-NOTES sacrocolpopexy and laparoscopic sacrocolpopexy, both performed without synthetic mesh. Participants will be randomly assigned (1:1) to either group. The study aims to evaluate outcomes using validated tools including POP-Q, PFDI-20, and PISQ-12 over a 6-month follow-up period.
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
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
- süleyman salman, prof, Study director, Gaziosmanpaşa Training and Research Hospitalhavva betül bacak, md, Principal investigator, Gaziosmanpaşa Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082023
- Sponsor's protocol ID
- gopvnotessacrocolpopexy
- Acronym
- vnotes
- Status last verified
- Jul 2025
- First submitted
- 4 Jul 2025
- Last updated
- 24 Jul 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 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of V-NOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery) Mesh-Free Sacrocolpopexy and Laparoscopic Mesh-Free Sacrocolpopexy
- ClinicalTrials.gov ID
- NCT07082023
- Acronym / sponsor ID
- vnotes / gopvnotessacrocolpopexy
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Sacrocolpopexy, vNOTES
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Havva Betül BacakOther government
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 24 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 study aims to compare the surgical outcomes, safety profiles, and patient satisfaction between two minimally invasive techniques for pelvic organ prolapse repair: Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) mesh-free sacrocolpopexy and laparoscopic mesh-free sacrocolpopexy. By evaluating perioperative data, complication rates, anatomical and functional outcomes, this trial seeks to determine whether the V-NOTES approach provides comparable or superior results to the traditional laparoscopic technique, without the use of synthetic mesh.
Detailed description
Pelvic organ prolapse (POP) is a common condition among women, especially with increasing age and parity, often requiring surgical intervention. Sacrocolpopexy is considered the gold standard for apical prolapse repair due to its high anatomical success rate and long-term durability. Traditionally performed via open or laparoscopic approaches, sacrocolpopexy has evolved with minimally invasive techniques.
Recently, mesh-related complications have led to a growing interest in mesh-free alternatives. Simultaneously, natural orifice approaches such as Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) have gained popularity due to better cosmetic results, reduced postoperative pain, and faster recovery times.
This prospective, comparative study aims to evaluate and compare the clinical outcomes of mesh-free sacrocolpopexy performed via V-NOTES versus the laparoscopic approach. Parameters including operative time, intraoperative and postoperative complications, hospital stay, pain scores, anatomical success, and patient satisfaction will be analyzed. The goal is to assess whether V-NOTES can be a safe and effective alternative to laparoscopic mesh-free sacrocolpopexy in the surgical management of POP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, interventional, randomized, parallel-group clinical trial comparing two minimally invasive surgical techniques for pelvic organ prolapse repair: V-NOTES sacrocolpopexy and laparoscopic sacrocolpopexy, both performed without synthetic mesh. Participants will be randomly assigned (1:1) to either group. The study aims to evaluate outcomes using validated tools including POP-Q, PFDI-20, and PISQ-12 over a 6-month follow-up period.
| Arm | Type | Receives |
|---|---|---|
| V-NOTES Sacrocolpopexy | Experimental | Procedure: V-NOTES Mesh-Free SacrocolpopexyPatients undergoing mesh-free sacrocolpopexy via vaginal natural orifice transluminal endoscopic surgery (V-NOTES). |
| Laparoscopic Sacrocolpopexy | Active comparator | Procedure: Laparoscopic Mesh-Free SacrocolpopexyPatients undergoing mesh-free sacrocolpopexy via conventional laparoscopy. |
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 Gaziosmanpaşa Education and Research Hospital, Gynecology and Obstetrics Clinic, who underwent surgery due to symptomatic pelvic organ prolapse with apical and anterior POP Q stage 2 and above, Being over 18 years old Patients who underwent surgery by experienced surgeons
Key exclusion criteria (1 listed)
- Having previously received KT and/or RT due to any malignancy Having previously undergone surgery due to proplasus Patients with severe cardiovascular or respiratory disease
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 |
|---|---|---|
| V-NOTES Mesh-Free SacrocolpopexyMesh-free sacrocolpopexy performed via vaginal natural orifice transluminal endoscopic surgery (V-NOTES). | Procedure or surgery | V-NOTES Sacrocolpopexy |
| Laparoscopic Mesh-Free SacrocolpopexyMesh-free sacrocolpopexy performed via conventional laparoscopy. | Procedure or surgery | Laparoscopic Sacrocolpopexy |
Primary outcome
Change in Pelvic Organ Prolapse Quantification (POP-Q) stage from baseline to 6 months
Time frame: Baseline and 6 months postoperative
Anatomical success will be evaluated using the POP-Q system. A reduction of prolapse stage by at least one level or achieving stage 0-1 will be considered successful.
Change in PISQ-12 Score
Time frame: Baseline and 6 months postoperative
Sexual function will be evaluated with PISQ-12. An increase in score indicates improvement.
Change in Pelvic Floor Distress Inventory-20 (PFDI-20) Score
Time frame: Baseline and 6 months postoperative
Patient-reported symptoms related to pelvic floor distress will be evaluated using the PFDI-20. A decrease in score indicates improvement in symptoms.
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 24 Jul 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.
süleyman salman, prof study director
Gaziosmanpaşa Training and Research Hospital
havva betül bacak, md principal investigator
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 V-NOTES Mesh-Free Sacrocolpopexy and Laparoscopic Mesh-Free Sacrocolpopexy 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 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 24 Jul 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?
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 ecenur çelikoğlu, md (+90 538 54 92 848, ecenurcelikoglu14@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pelvic Organ Prolapse Quantification (POP-Q) stage from baseline to 6 months (time frame: Baseline and 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 24 Jul 2025.