Pelvic Organ ProlapseHUSLSNCT07552337
Unilateral Versus Bilateral High Uterosacral Ligament Suspension Following vNOTES Hysterectomy for Apical Pelvic Organ Prolapse: A Prospective Study
A study testing High Uterosacral Ligament Suspension in people with Pelvic Organ Prolapse, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare unilateral and bilateral high uterosacral ligament suspension techniques performed following vaginal hysterectomy in patients with pelvic organ prolapse. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- High Uterosacral Ligament Suspension
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Jan 2026
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18 years and older
- Diagnosis of pelvic organ prolapse requiring surgical treatment
- Planned vaginal hysterectomy with high uterosacral ligament suspension
- Ability to provide informed consent
Who cannot join
- Previous pelvic organ prolapse surgery involving apical support
- Presence of pelvic malignancy
- Active pelvic infection
- Severe comorbidities contraindicating surgery
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Saglik Bilimleri University Gazi Yasargil Training and Research Hospital
Diyarbakır, 21000
About this study
This study aims to compare unilateral and bilateral high uterosacral ligament suspension techniques performed following vaginal hysterectomy in patients with pelvic organ prolapse. The objective is to evaluate the effectiveness and safety of both surgical approaches in terms of anatomical outcomes and postoperative complications. The results of this study may help guide surgical decision-making in the management of pelvic organ prolapse.
Read the detailed description
Pelvic organ prolapse is a common condition affecting women, often requiring surgical intervention. Vaginal hysterectomy combined with high uterosacral ligament suspension is a widely used technique for apical support. However, there is ongoing debate regarding whether unilateral or bilateral suspension provides better anatomical and clinical outcomes.
This study is designed as a comparative clinical study evaluating unilateral versus bilateral high uterosacral ligament suspension performed following vaginal hysterectomy. Patients undergoing surgery for pelvic organ prolapse will be included and assigned to one of the two surgical approaches according to the study design.
The primary objective is to compare anatomical success rates between the two techniques. Secondary outcomes include perioperative complications, recurrence rates, and postoperative functional outcomes.
The findings of this study are expected to provide evidence regarding the optimal surgical approach for uterosacral ligament suspension and contribute to improving patient outcomes in pelvic organ prolapse surgery.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- High Uterosacral Ligament Suspension
- Keywords
- Uterosacral Ligament Suspension, Vaginal Hysterectomy, Pelvic Organ Prolapse Surgery, Apical Support, Unilateral vs Bilateral
- 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.
High Uterosacral Ligament SuspensionProcedure or surgery
High uterosacral ligament suspension is a surgical procedure performed following vaginal hysterectomy to provide apical support in patients with pelvic organ prolapse. In this study, the procedure is performed either unilaterally or bilaterally depending on group assignment.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral High Uterosacral Ligament Suspension | Experimental | Participants undergo unilateral high uterosacral ligament suspension following vaginal hysterectomy for pelvic organ prolapse. Receives: Procedure: High Uterosacral Ligament Suspension |
| Bilateral High Uterosacral Ligament Suspension | Experimental | Participants undergo bilateral high uterosacral ligament suspension following vaginal hysterectomy for pelvic organ prolapse. Receives: Procedure: High Uterosacral Ligament Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical Success Rate
Anatomical success defined as the absence of pelvic organ prolapse at or beyond the hymen, assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system.
Measured: 12 months postoperatively
Secondary outcomes (5)
Prolapse Recurrence Rate
Recurrence of pelvic organ prolapse defined as descent of any vaginal compartment to or beyond the hymen during follow-up.
Measured: 12 months postoperatively
Operative Time
Duration of surgery measured from incision to completion of the procedure.
Measured: Intraoperative
Intraoperative Complications
Occurrence of complications during surgery, including bleeding, ureteral injury, or other surgical complications.
Measured: During surgery
Postoperative Complications
Complications occurring after surgery, including infection, pain, or need for reoperation.
Measured: Up to 30 days postoperatively
Functional Outcomes
Patient-reported outcomes including urinary, bowel, and sexual function assessed using validated questionnaires.
Measured: 6 and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start1 Jan 2023
- Primary completion1 Jan 2024
- Study completion1 Jan 2026
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to one of two groups undergoing either unilateral or bilateral high uterosacral ligament suspension following vaginal hysterectomy.
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdurrahman Sengi, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Investigators
- abdurrahman sengi, MD, Principal investigator, Saglik Bilimleri University Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552337
- Sponsor's protocol ID
- 683
- Acronym
- HUSLS
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unilateral Versus Bilateral High Uterosacral Ligament Suspension Following vNOTES Hysterectomy for Apical Pelvic Organ Prolapse: A Prospective Study
- ClinicalTrials.gov ID
- NCT07552337
- Acronym / sponsor ID
- HUSLS / 683
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Uterosacral Ligament Suspension, Vaginal Hysterectomy, Pelvic Organ Prolapse Surgery, Apical Support, Unilateral vs Bilateral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 27 Apr 2026 (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 unilateral and bilateral high uterosacral ligament suspension techniques performed following vaginal hysterectomy in patients with pelvic organ prolapse. The objective is to evaluate the effectiveness and safety of both surgical approaches in terms of anatomical outcomes and postoperative complications. The results of this study may help guide surgical decision-making in the management of pelvic organ prolapse.
Detailed description
Pelvic organ prolapse is a common condition affecting women, often requiring surgical intervention. Vaginal hysterectomy combined with high uterosacral ligament suspension is a widely used technique for apical support. However, there is ongoing debate regarding whether unilateral or bilateral suspension provides better anatomical and clinical outcomes.
This study is designed as a comparative clinical study evaluating unilateral versus bilateral high uterosacral ligament suspension performed following vaginal hysterectomy. Patients undergoing surgery for pelvic organ prolapse will be included and assigned to one of the two surgical approaches according to the study design.
The primary objective is to compare anatomical success rates between the two techniques. Secondary outcomes include perioperative complications, recurrence rates, and postoperative functional outcomes.
The findings of this study are expected to provide evidence regarding the optimal surgical approach for uterosacral ligament suspension and contribute to improving patient outcomes in pelvic organ prolapse surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to one of two groups undergoing either unilateral or bilateral high uterosacral ligament suspension following vaginal hysterectomy.
| Arm | Type | Receives |
|---|---|---|
| Unilateral High Uterosacral Ligament Suspension | Experimental | Procedure: High Uterosacral Ligament SuspensionParticipants undergo unilateral high uterosacral ligament suspension following vaginal hysterectomy for pelvic organ prolapse. |
| Bilateral High Uterosacral Ligament Suspension | Experimental | Procedure: High Uterosacral Ligament SuspensionParticipants undergo bilateral high uterosacral ligament suspension following vaginal hysterectomy for pelvic organ prolapse. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients aged 18 years and older
- Diagnosis of pelvic organ prolapse requiring surgical treatment
- Planned vaginal hysterectomy with high uterosacral ligament suspension
- Ability to provide informed consent
Key exclusion criteria (5 listed)
- Previous pelvic organ prolapse surgery involving apical support
- Presence of pelvic malignancy
- Active pelvic infection
- Severe comorbidities contraindicating surgery
- Pregnancy
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 |
|---|---|---|
| High Uterosacral Ligament SuspensionHigh uterosacral ligament suspension is a surgical procedure performed following vaginal hysterectomy to provide apical support in patients with pelvic organ prolapse. In this study, the procedure is performed either unilaterally or bilaterally depending on group assignment. | Procedure or surgery | Bilateral High Uterosacral Ligament Suspension, Unilateral High Uterosacral Ligament Suspension |
Primary outcome
Anatomical Success Rate
Time frame: 12 months postoperatively
Anatomical success defined as the absence of pelvic organ prolapse at or beyond the hymen, assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system.
5 secondary outcomes
Prolapse Recurrence Rate
Time frame: 12 months postoperatively
Operative Time
Time frame: Intraoperative
Intraoperative Complications
Time frame: During surgery
Postoperative Complications
Time frame: Up to 30 days postoperatively
Functional Outcomes
Time frame: 6 and 12 months postoperatively
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 27 Apr 2026.
- Individual participant dataSharing planned: No. No plan to share individual participant data.
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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.
abdurrahman sengi, MD principal investigator
Saglik Bilimleri University Gazi Yasargil 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 High Uterosacral Ligament Suspension in people with Pelvic Organ Prolapse, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research 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 4 inclusion and 5 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 27 Apr 2026. 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 Rate (time frame: 12 months postoperatively). 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 27 Apr 2026.