Pelvic Organ ProlapseNCT06341088
Evaluation of Anatomical Results and Sexual Functions After Unilateral and Bilateral Laparoscopic Suture Sacro-hysteropexy Operations
A study testing unilateral suture sacro-hysteropexy and bilateral suture sacro-hysteropexy in people with Pelvic Organ Prolapse, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The study was planned as prospective and randomized. For the study, patients will be randomized into two groups as unilateral and bilateral suture sacro-hysteropexy operations. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- unilateral suture sacro-hysteropexy and bilateral suture sacro-hysteropexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2024to 5 Feb 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients between the ages of 18-60
- No previous prolapse surgery
- Not having a chronic disease
- Having stage 3-4 prolapse
Who cannot join
- Outside the age range of 18-60 years
- Previous prolapse surgery
- Having early stage (1-2) prolapse
- History of chronic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Anatomical Results and Sexual Functions After Unilateral and Bilateral Laparoscopic Suture Sacro-hysteropexy Operations, a Prospective Randomised Study
The study was planned as prospective and randomized. For the study, patients will be randomized into two groups as unilateral and bilateral suture sacro-hysteropexy operations.
Read the detailed description
The study was planned as prospective and randomized. For the study, patients will be randomized into two groups as unilateral and bilateral suture sacro-hysteropexy operations.Computerized random number table will be used as randomization method. Patients who agree to participate in the study and fulfill the inclusion criteria will be evaluated on the effects of prolapse on quality of life and sexual function before and after the surgical procedures and their complaints and satisfaction will be questioned. Surgical success and complications will be evaluated. Changes in the level of prolapse will be evaluated.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- unilateral suture sacro-hysteropexy, bilateral suture sacro-hysteropexy
- Keywords
- suture sacro hysteropexy, 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.
unilateral suture sacro-hysteropexyProcedure or surgery
patients in this group will undergo unilateral sacrouterine ligament plication with nonabsorbable suture and unilaterally suspended to the anterior longitudinal ligament.
bilateral suture sacro-hysteropexyProcedure or surgery
patients in this group will undergo bilateral sacrouterine ligament plication with nonabsorbable suture and bilaterally suspended to the anterior longitudinal ligament.
| Study group | Role | What they receive |
|---|---|---|
| unilateral suture sacro-hysteropexy | Active comparator | patients in this group will undergo unilateral sacrouterine ligament plication with nonabsorbable suture and unilaterally suspended to the anterior longitudinal ligament. Receives: Procedure: unilateral suture sacro-hysteropexy |
| bilateral suture sacro-hysteropexy | Active comparator | patients in this group will undergo bilateral sacrouterine ligament plication with nonabsorbable sutures and bilaterally suspended to the anterior longitudinal ligament. Receives: Procedure: bilateral suture sacro-hysteropexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
anatomical success of the operations
comparition of preoperative and postoperative pelvic organ prolapse quantification system (POP-Q) measurements of the patients
Measured: changes at 1 and 3 months after surgery
Secondary outcomes (1)
evaluation of the sexual functions of the patients
comparition of preoperative and postoperative FSFI(female sexual function index) scores of the patients
Measured: changes at 1 and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start5 Apr 2024
- Primary completion5 Nov 2024
- Study completion5 Feb 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.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Nur Cimilli Şenocak, Ataturk University
- Investigators
- Gamze Nur Cimilli Senocak, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341088
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/132
- Status last verified
- Jul 2025
- First submitted
- 19 Mar 2024
- Last updated
- 17 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anatomical Results and Sexual Functions After Unilateral and Bilateral Laparoscopic Suture Sacro-hysteropexy Operations, a Prospective Randomised Study
- ClinicalTrials.gov ID
- NCT06341088
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/132
- Conditions
- Pelvic Organ Prolapse
- Keywords
- suture sacro hysteropexy, Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 5 Nov 2024 (actual)
- Study completion
- 5 Feb 2025 (actual)
- First posted
- 2 Apr 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.
The study was planned as prospective and randomized. For the study, patients will be randomized into two groups as unilateral and bilateral suture sacro-hysteropexy operations.
Detailed description
The study was planned as prospective and randomized. For the study, patients will be randomized into two groups as unilateral and bilateral suture sacro-hysteropexy operations.Computerized random number table will be used as randomization method. Patients who agree to participate in the study and fulfill the inclusion criteria will be evaluated on the effects of prolapse on quality of life and sexual function before and after the surgical procedures and their complaints and satisfaction will be questioned. Surgical success and complications will be evaluated. Changes in the level of prolapse will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unilateral suture sacro-hysteropexy | Active comparator | Procedure: unilateral suture sacro-hysteropexypatients in this group will undergo unilateral sacrouterine ligament plication with nonabsorbable suture and unilaterally suspended to the anterior longitudinal ligament. |
| bilateral suture sacro-hysteropexy | Active comparator | Procedure: bilateral suture sacro-hysteropexypatients in this group will undergo bilateral sacrouterine ligament plication with nonabsorbable sutures and bilaterally suspended to the anterior longitudinal ligament. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients between the ages of 18-60
- No previous prolapse surgery
- Not having a chronic disease
- Having stage 3-4 prolapse
Key exclusion criteria (4 listed)
- Outside the age range of 18-60 years
- Previous prolapse surgery
- Having early stage (1-2) prolapse
- History of chronic 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 |
|---|---|---|
| unilateral suture sacro-hysteropexypatients in this group will undergo unilateral sacrouterine ligament plication with nonabsorbable suture and unilaterally suspended to the anterior longitudinal ligament. | Procedure or surgery | unilateral suture sacro-hysteropexy |
| bilateral suture sacro-hysteropexypatients in this group will undergo bilateral sacrouterine ligament plication with nonabsorbable suture and bilaterally suspended to the anterior longitudinal ligament. | Procedure or surgery | bilateral suture sacro-hysteropexy |
Primary outcome
anatomical success of the operations
Time frame: changes at 1 and 3 months after surgery
comparition of preoperative and postoperative pelvic organ prolapse quantification system (POP-Q) measurements of the patients
1 secondary outcome
evaluation of the sexual functions of the patients
Time frame: changes at 1 and 3 months 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 17 Jul 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.
Gamze Nur Cimilli Senocak principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing unilateral suture sacro-hysteropexy and bilateral suture sacro-hysteropexy in people with Pelvic Organ Prolapse, run by Ataturk University 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 4 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 17 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?
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 of the operations (time frame: changes at 1 and 3 months after surgery). 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 17 Jul 2025.