Genital Prolapse, UnspecifiedNCT06307873
Comparison of the Effects of Sacrospinous Fixation and V-notes Lateral Suspension Operations
A study testing pre and post operative POP-Q results and pre and post operative PİSQ-12 results in people with Genital Prolapse, Unspecified, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Comparison of the effects of sacrospinous fixation and v-notes lateral suspension operations on anatomical recovery, effectiveness and quality of life in a training and research hospital gynecology and obstetrics clinic. Read more about this study
- Who is it for?
- Ages 35 to 75 years, women only
- Conditions the study is for
- Genital Prolapse, Unspecified
- What is being tested?
- pre and post operative POP-Q results and pre and post operative PİSQ-12 results
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Sep 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 35 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient aged 35-75 patients without pelvic mess, servical or endometrial lesion
Who cannot join
- patients with pelvic mess, servical or endometrial lesion patient with diagnosed endometrial cancer
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Training and Research Hospital
Istanbul
About this study
Official title: Comparison of the Effects of Sacrospinous Fixation and V-notes Lateral Suspension Operations on Anatomical Recovery, Effectiveness and Quality of Life.
Comparison of the effects of sacrospinous fixation and v-notes lateral suspension operations on anatomical recovery, effectiveness and quality of life in a training and research hospital gynecology and obstetrics clinic.
- Conditions
- Genital Prolapse, Unspecified
- Being tested
- pre and post operative POP-Q results, pre and post operative PİSQ-12 results
- Keywords
- sacrospinous fixation, v-notes lateral suspension, genital prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre and post operative POP-Q resultsDiagnostic test
Comparison of pre and postoperative POP-Q values of the patients undergone Sacrospinous Fixation operation and V-notes Lateral Suspension Operation
pre and post operative PİSQ-12 resultsBehavioural
Comparison of pre and postoperative PİSQ-12 values of the patients undergone Sacrospinous Fixation operation and V-notes Lateral Suspension Operation
| Study group | Role | What they receive |
|---|---|---|
| patients undergone Sacrospinous Fixation operation | Active comparator | Not described Receives: Diagnostic Test: pre and post operative POP-Q results; Behavioral: pre and post operative PİSQ-12 results |
| patients undergone V-notes Lateral Suspension Operation | Active comparator | Not described Receives: Diagnostic Test: pre and post operative POP-Q results; Behavioral: pre and post operative PİSQ-12 results |
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 Sacrospinous Fixation and V-notes Lateral Suspension Operations on Pelvic Organ Prolapse will be compared
Measured: 1 year
Pre and post operative assessment of Pelvic Organ Prolapse / Incontinence Sexual
PISQ-12 values of patients before and after Sacrospinous Fixation and V-notes Lateral Suspension Operations on Pelvic Organ Prolapse will be compared
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 posted13 Mar 2024
- Study start1 Sep 2023
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital Prolapse, UnspecifiedStudies 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
- Masking
- None (open label)
- Enrolment
- 70 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
- NCT06307873
- Sponsor's protocol ID
- GaziosmanpasaTREH.
- Status last verified
- Dec 2024
- First submitted
- 6 Mar 2024
- Last updated
- 25 Nov 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 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Sacrospinous Fixation and V-notes Lateral Suspension Operations on Anatomical Recovery, Effectiveness and Quality of Life.
- ClinicalTrials.gov ID
- NCT06307873
- Acronym / sponsor ID
- GaziosmanpasaTREH.
- Conditions
- Genital Prolapse, Unspecified
- Keywords
- sacrospinous fixation, v-notes lateral suspension, genital prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 13 Mar 2024 (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.
Comparison of the effects of sacrospinous fixation and v-notes lateral suspension operations on anatomical recovery, effectiveness and quality of life in a training and research hospital gynecology and obstetrics clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients undergone Sacrospinous Fixation operation | Active comparator | Diagnostic Test: pre and post operative POP-Q results, Behavioral: pre and post operative PİSQ-12 results |
| patients undergone V-notes Lateral Suspension Operation | Active comparator | Diagnostic Test: pre and post operative POP-Q results, Behavioral: pre and post operative PİSQ-12 results |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient aged 35-75 patients without pelvic mess, servical or endometrial lesion
Key exclusion criteria (1 listed)
- patients with pelvic mess, servical or endometrial lesion patient with diagnosed endometrial cancer
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 |
|---|---|---|
| pre and post operative POP-Q resultsComparison of pre and postoperative POP-Q values of the patients undergone Sacrospinous Fixation operation and V-notes Lateral Suspension Operation | Diagnostic test | patients undergone Sacrospinous Fixation operation, patients undergone V-notes Lateral Suspension Operation |
| pre and post operative PİSQ-12 resultsComparison of pre and postoperative PİSQ-12 values of the patients undergone Sacrospinous Fixation operation and V-notes Lateral Suspension Operation | Behavioural | patients undergone Sacrospinous Fixation operation, patients undergone V-notes Lateral Suspension Operation |
Primary outcome
Pre and post operative assessment of POP-Q measurements
Time frame: 1 year
POP-Q values of patients before and after Sacrospinous Fixation and V-notes Lateral Suspension Operations on Pelvic Organ Prolapse will be compared
Pre and post operative assessment of Pelvic Organ Prolapse / Incontinence Sexual
Time frame: 1 year
PISQ-12 values of patients before and after Sacrospinous Fixation and V-notes Lateral Suspension Operations on Pelvic Organ Prolapse will be compared
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 25 Nov 2025.
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 pre and post operative POP-Q results and pre and post operative PİSQ-12 results in people with Genital Prolapse, Unspecified, 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 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: finished, as of the sponsor's last update on 25 Nov 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 25 Nov 2025.