Ureteral Patency After Uterosacral Ligaments Suspension

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery--Complications; Ureteral Injury; Uterovaginal Prolapse
• Intervention / Treatment: Diagnostic test: Transabdominal ultrasound and cistoscopy

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Matteo Frigerio, Dr; Phone Number: 3406002013; Email: frigerio86@gmail.com

Study Locations

• Italy
  • MB
    • Monza, MB, Italy, 20900
      • Recruiting
      • University of Milano Bicocca
      • Contact: Matteo Frigerio, MD; Phone Number: +393406002013

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

All patients subjected to uterosacral ligaments suspension procedures for pelvic organs prolapse will be enrolled.

Description

Inclusion Criteria:

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.

Exclusion Criteria:

None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group of study; Patients ≥ 18 years old subjected to uterosacral ligaments suspension surgical procedures for pelvic organs prolapse.	Diagnostic test: Transabdominal ultrasound and cistoscopy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration	the duration of ultrasound procedure (minutes) compared with the duration of cystoscopy procedure (minutes).	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University of Milano Bicocca

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): October 31, 2022

Study Registration Dates

• First Submitted: May 3, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: ultrasound; Uterovaginal prolapse; uterosacral ligament suspension; ureteral patency
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse
• Other Study ID Numbers: US-URETERS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No