Pelvic Organ ProlapseNCT06176521
Evaluation of the Results of Laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Performed Without Mesh in the Surgical Treatment of Pelvic Organ Prolapse
A study testing Laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Performed Without Mesh in people with Pelvic Organ Prolapse, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Evaluation of the anatomical and functional results of laparoscopic sacrohysteropexy and sacrocolpopexy surgeries performed without using mesh in the surgical treatment of pelvic organ prolapse Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Performed Without Mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 1 Jun 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being 18 years old or older
- needing an operation for symptomatic pelvic organ prolapse -
Who cannot join
- past history of chemotherapy or radiotherapy
- past history of pelvic organ prolapse surgery
- if there is a contraindication of laparoscopy -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Training and Research Hospital
Istanbul
About this study
Evaluation of the anatomical and functional results of laparoscopic sacrohysteropexy and sacrocolpopexy surgeries performed without using mesh in the surgical treatment of pelvic organ prolapse
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Performed Without Mesh
- Keywords
- sacrocolpopexy, sacrohysteropexy, pelvic organ 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.
Laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Performed Without MeshProcedure or surgery
Also called Comparison of pre and postoperative POP-Q values of the patients undergone Laparoscopic Sacrohysteropexy and Sacrocolpopexy SurgeriesWithout Using Mesh, Comparison of pre and postoperative PISQ-12 scores of the patients undergone Laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Without Using Mesh
Comparison of pre and postoperative POP-Q values of the patients undergone Laparoscopic Sacrohysteropexy and Sacrocolpopexy SurgeriesWithout Using Mesh Comparison of pre and postoperative PISQ-12 scores of the patients undergone Laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Without Using Mesh
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Performed Without Mesh | Other | Not described Receives: Procedure: Laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Performed Without Mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre and post operative assessment of POP-Q measurements
POP-Q values of patients before and after laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Performed Without Mesh on Pelvic Organ Prolapse will be compared.
Measured: 1 year
Pre and post operative assessment of Pelvic Organ Prolapse / Incontinence Sexual
Units on a scale of the patients obtained with Pelvic Organ Prolapse / Incontinence Sexual Questionnaire (PISQ-12) will be compared before and after surgery.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start1 Nov 2023
- Primary completion1 Dec 2024
- Study completion1 Jun 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
- Not applicable
- Intervention model
- Single group
- Model description
- before and after surgery results of a single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176521
- Sponsor's protocol ID
- GaziosmanpasaTREHs
- Status last verified
- Nov 2024
- First submitted
- 9 Dec 2023
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Results of Laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Performed Without Mesh in the Surgical Treatment of Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT06176521
- Acronym / sponsor ID
- GaziosmanpasaTREHs
- Conditions
- Pelvic Organ Prolapse
- Keywords
- sacrocolpopexy, sacrohysteropexy, pelvic organ prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 19 Dec 2023 (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.
Evaluation of the anatomical and functional results of laparoscopic sacrohysteropexy and sacrocolpopexy surgeries performed without using mesh in the surgical treatment of 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
- before and after surgery results of a single group
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Performed Without Mesh | Other | Procedure: Laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Performed Without Mesh |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- being 18 years old or older
- needing an operation for symptomatic pelvic organ prolapse -
Key exclusion criteria (3 listed)
- past history of chemotherapy or radiotherapy
- past history of pelvic organ prolapse surgery
- if there is a contraindication of laparoscopy -
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 Sacrohysteropexy and Sacrocolpopexy Surgeries Performed Without MeshAlso: Comparison of pre and postoperative POP-Q values of the patients undergone Laparoscopic Sacrohysteropexy and Sacrocolpopexy SurgeriesWithout Using Mesh, Comparison of pre and postoperative PISQ-12 scores of the patients undergone Laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Without Using MeshComparison of pre and postoperative POP-Q values of the patients undergone Laparoscopic Sacrohysteropexy and Sacrocolpopexy SurgeriesWithout Using Mesh Comparison of pre and postoperative PISQ-12 scores of the patients undergone Laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Without Using Mesh | Procedure or surgery | Laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Performed Without Mesh |
Primary outcome
Pre and post operative assessment of POP-Q measurements
Time frame: 1 year
POP-Q values of patients before and after laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Performed Without Mesh on Pelvic Organ Prolapse will be compared.
Pre and post operative assessment of Pelvic Organ Prolapse / Incontinence Sexual
Time frame: 1 year
Units on a scale of the patients obtained with Pelvic Organ Prolapse / Incontinence Sexual Questionnaire (PISQ-12) will be compared before and after surgery.
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 6 Aug 2025.
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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.
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?
A study testing Laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Performed Without Mesh in people with Pelvic Organ Prolapse, run by Gaziosmanpasa Research and Education Hospital 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 2 inclusion and 3 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 6 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?
Pre and post operative assessment of POP-Q measurements (time frame: 1 year). 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 6 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.