Uterovaginal ProlapseNCT05477043
Ureteral Patency After Uterosacral Ligaments Suspension
An observational study of Uterovaginal Prolapse and Ureteral Injury, run by University of Milano Bicocca at 1 site in Italy.
Trial summary
Uterosacral ligament suspension (USLS) is a commonly performed procedure used to correct prolapse of the vaginal apex. The procedure consists of approximating the vaginal apex to the uterosacral ligaments with a series of sutures placed bilaterally, and is most often performed from a transvaginal approach. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterovaginal Prolapse, Ureteral Injury, Surgery--Complications
- What is being tested?
- Transabdominal ultrasound and cistoscopy
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2021to 31 Oct 2022
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients subjected to uterosacral ligaments suspension procedures for pelvic organs prolapse will be enrolled.
Who may be able to join
- Patients ≥ 18 years old subjected to uterosacral ligaments suspension surgical procedures for pelvic organs prolapse.
- Informed consent freely granted and acquired before the start of the study.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Milano Bicocca
Monza, MB, 20900
Matteo Frigerio, MD, +393406002013
About this study
Official title: Ultrasound Evaluation of Ureteral Patency After Uterosacral Ligaments Suspension
Uterosacral ligament suspension (USLS) is a commonly performed procedure used to correct prolapse of the vaginal apex. The procedure consists of approximating the vaginal apex to the uterosacral ligaments with a series of sutures placed bilaterally, and is most often performed from a transvaginal approach. USLS is associated with favorable outcomes and is overall safe. However, given the anatomical proximity of the uterosacral ligaments to the ureters, ureteral injury during suspension suture placement may occur. Ureteral occlusion in this setting occurs as a result of partial or complete ligation, kinking or anatomical distortion by the nearby sutures. As a measure for avoiding these undesired sequelae, cystoscopy is usually performed after suspension suture placement during USLS to ensure visualization of bilateral ureteral flow. Any interruption of ureteral flow is usually addressed by removal of the suspension sutures, ureteral stenting, and, rarely, surgical repair of the ureter if severe injury is sustained.
Ultrasound can identify the ureteral jet of urine flowing into the bladder. Previous studies demonstrated ureteral jet asymmetry in case of obstruction, with an absent or weaker monolateral jet.
Read the detailed description
It's a prospective observational monocentric study. 100 consecutive patients subjected to uterosacral ligaments suspension procedures for pelvic organs prolapse will be enrolled. Considering the surgical activity of our department we plan to enroll this number of patients within 18 months. After the surgical procedure, while still in the operatory room, they will be subjected to ultrasound evaluation of ureteral patency before being subjected to diagnostic cystoscopy. Ultrasound will be performed before cystoscopy in order not to be influenced by the results of the gold standard procedure. Ultrasound and cystoscopy will be performed by different operators in order not to be influenced by the results.
Intravenous somministration of 300 ml of saline solution will be performed 10 to 15 minutes before the end of the surgical procedure. Bladder will be filled with 300 ml of mannitol solution. All ultrasounds will be obtained with a convex 3.5-MHz probe. Ultrasound examination of the bladder will be performed in transverse planes. Bilateral simultaneous ureteral jet evaluation with power Doppler will be performed at the level of the ureterovesical junctions with a pulse repetition frequency set to detect low flow for 3 minutes, as previously described. The power Doppler field size will include the entire posterior wall of the bladder. Ureteral patency test will be considered normal if jets will be present at least once on each side. It will be considered abnormal when either absent or comparatively diminished on the ipsilateral side and well visualized on the contralateral side. It will be considered nondiagnostic when neither side was visualized during the 3 minutes. Ultrasound test results will be noted and after that diagnostic cystoscopy will be performed.
Postoperative care will be usual.
- Being tested
- Transabdominal ultrasound and cistoscopy
- Keywords
- Uterovaginal prolapse, uterosacral ligament suspension, ureteral patency, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transabdominal ultrasound and cistoscopyDiagnostic test
Ultrasound detection of the bilateral ureteral jets vs absence of the ureteral jet on one side compared with the presence of bilateral ureteral jet on cystoscopy vs absence on one side.
| Study group | Role | What they receive |
|---|---|---|
| group of study | Patients ≥ 18 years old subjected to uterosacral ligaments suspension surgical procedures for pelvic organs prolapse. Receives: Diagnostic Test: Transabdominal ultrasound and cistoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of ureteral patency
ultrasound detection of the bilateral ureteral jets vs absence of the ureteral jet on one side compared with the presence of bilateral ureteral jet on cystoscopy vs absence on one side.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Duration
the duration of ultrasound procedure (minutes) compared with the duration of cystoscopy procedure (minutes).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start1 Apr 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterovaginal 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477043
- Sponsor's protocol ID
- US-URETERS
- Status last verified
- Jul 2022
- First submitted
- 3 May 2022
- Last updated
- 28 Jul 2022
- 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 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Evaluation of Ureteral Patency After Uterosacral Ligaments Suspension
- ClinicalTrials.gov ID
- NCT05477043
- Acronym / sponsor ID
- US-URETERS
- Keywords
- Uterovaginal prolapse, uterosacral ligament suspension, ureteral patency, ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 28 Jul 2022 (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.
Uterosacral ligament suspension (USLS) is a commonly performed procedure used to correct prolapse of the vaginal apex. The procedure consists of approximating the vaginal apex to the uterosacral ligaments with a series of sutures placed bilaterally, and is most often performed from a transvaginal approach. USLS is associated with favorable outcomes and is overall safe. However, given the anatomical proximity of the uterosacral ligaments to the ureters, ureteral injury during suspension suture placement may occur. Ureteral occlusion in this setting occurs as a result of partial or complete ligation, kinking or anatomical distortion by the nearby sutures. As a measure for avoiding these undesired sequelae, cystoscopy is usually performed after suspension suture placement during USLS to ensure visualization of bilateral ureteral flow. Any interruption of ureteral flow is usually addressed by removal of the suspension sutures, ureteral stenting, and, rarely, surgical repair of the ureter if severe injury is sustained.
Ultrasound can identify the ureteral jet of urine flowing into the bladder. Previous studies demonstrated ureteral jet asymmetry in case of obstruction, with an absent or weaker monolateral jet.
Detailed description
It's a prospective observational monocentric study. 100 consecutive patients subjected to uterosacral ligaments suspension procedures for pelvic organs prolapse will be enrolled. Considering the surgical activity of our department we plan to enroll this number of patients within 18 months. After the surgical procedure, while still in the operatory room, they will be subjected to ultrasound evaluation of ureteral patency before being subjected to diagnostic cystoscopy. Ultrasound will be performed before cystoscopy in order not to be influenced by the results of the gold standard procedure. Ultrasound and cystoscopy will be performed by different operators in order not to be influenced by the results.
Intravenous somministration of 300 ml of saline solution will be performed 10 to 15 minutes before the end of the surgical procedure. Bladder will be filled with 300 ml of mannitol solution. All ultrasounds will be obtained with a convex 3.5-MHz probe. Ultrasound examination of the bladder will be performed in transverse planes. Bilateral simultaneous ureteral jet evaluation with power Doppler will be performed at the level of the ureterovesical junctions with a pulse repetition frequency set to detect low flow for 3 minutes, as previously described. The power Doppler field size will include the entire posterior wall of the bladder. Ureteral patency test will be considered normal if jets will be present at least once on each side. It will be considered abnormal when either absent or comparatively diminished on the ipsilateral side and well visualized on the contralateral side. It will be considered nondiagnostic when neither side was visualized during the 3 minutes. Ultrasound test results will be noted and after that diagnostic cystoscopy will be performed.
Postoperative care will be usual.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group of study | – | Diagnostic Test: Transabdominal ultrasound and cistoscopyPatients ≥ 18 years old subjected to uterosacral ligaments suspension surgical procedures for pelvic organs prolapse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients subjected to uterosacral ligaments suspension procedures for pelvic organs prolapse will be enrolled.
Key inclusion criteria (2 listed)
- Patients ≥ 18 years old subjected to uterosacral ligaments suspension surgical procedures for pelvic organs prolapse.
- Informed consent freely granted and acquired before the start of the study.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Transabdominal ultrasound and cistoscopyUltrasound detection of the bilateral ureteral jets vs absence of the ureteral jet on one side compared with the presence of bilateral ureteral jet on cystoscopy vs absence on one side. | Diagnostic test | group of study |
Primary outcome
Detection of ureteral patency
Time frame: through study completion, an average of 1 year
ultrasound detection of the bilateral ureteral jets vs absence of the ureteral jet on one side compared with the presence of bilateral ureteral jet on cystoscopy vs absence on one side.
1 secondary outcome
Duration
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterovaginal Prolapse and Ureteral Injury, run by University of Milano Bicocca at 1 site in Italy.
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 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: status not confirmed, as of the sponsor's last update on 28 Jul 2022. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matteo Frigerio, Dr (3406002013, frigerio86@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of ureteral patency (time frame: through study completion, an average of 1 year). 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 28 Jul 2022.