Uterosacral Ligament Suspension Clip (USLS)

Uterosacral Ligament Suspension: A Radiographic Study of Anatomy and Suture Location

This study seeks to gain a more thorough understanding of the postoperative location of the sutures placed during uterosacral ligament suspension. Characterization of the surrounding anatomy in a living model will enhance surgical technique by delineating safer suture locations and decrease the incidence of morbid complications for patients.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Device: Vascular Clip

Detailed Description

Uterosacral ligament suspension Is a commonly performed procedure to support the vaginal apex at the time of pelvic reconstructive surgery for pelvic organ prolapse (POP). Despite being a well established durable option for patients, there is little research detailing ligament suspension suture location in the living model. The available literature is limited to cadaveric studies, which suggest suture placement is in close proximity to vital structures such as the ureter, blood vessels, rectum and nerves.

This study seeks to describe suture location in relation to the surrounding anatomy in postoperative patients following high uterosacral ligament suspension. The secondary aim is to determine safe zones for suture placement.

Seventeen women (aged 18-85) under the care of Cincinnati Urogynecology Associates, a physician group of TriHealth, who have chosen vaginal hysterectomy with uterosacral ligament suspension (USLS) as the treatment choice for pelvic organ prolapse (POP) will be enrolled.

At the time of surgery, a titanium vascular clip (size small) will be applied to the base of each delayed absorbable suture placed at the vaginal apex on the internal vaginal side to help in identification by imaging.

On postoperative day (POD) 1, patients will undergo CT pelvis scans. The CT scan will involve administration of IV contrast for imaging of the ureters and vascular structures. The clip will fall off when the sutures dissolve at 12 weeks postoperatively. All patients will be asked to complete a lower extremity neurological questionnaire preoperatively and postoperatively.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Cincinnati Urogynecology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• women aged 18-85 with pelvic organ prolapse (POP) who have elected uterosacral ligament suspension (USLS) for treatment

Exclusion Criteria:

• contraindication to computed tomography (CT), or intravenous (IV) contrast
• those with claustrophobia
• previous POP surgery
• previous pelvic surgery to the fallopian tubes, ovaries, or rectum
• previous pelvic radiation
• known pelvic inflammatory disease or endometriosis
• those with preexisting ureteral or vascular pathology or sacral anatomic abnormality
• those with connective tissue disorders
• those with preexisting neuropathy, chronic lower extremity pain disorders, or neurological disorders
• those with renal anomalies such as pelvic kidney, duplication of the collecting system, prior nephrectomy
• those with allergy to titanium
• removal of the uterosacral sutures due to ureteral obstruction intraoperatively

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vascular clip; Application of a clip to dissolvable sutures.	Device: Vascular Clip; Application of a titanium vascular clip (size small) to the base of each delayed absorbable suture placed at the vaginal apex on the internal vaginal side to help in identification by imaging; Other Names: Clip

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suture Location in Relation to the Surrounding Anatomy	Measurement between internal iliac complex and proximal suture; measurement between ureter and proximal/distal suture.	1 day after surgery

Collaborators and Investigators

• Sponsor: TriHealth Inc.

Publications and helpful links

General Publications

• Smith BC, Herfel CV, Yeung J, Shatkin-Margolis A, Crisp CC, Kleeman SD, Pauls RN. Uterosacral Ligament Suspension: A Radiographic Study of Suture Location in Live Subjects. Female Pelvic Med Reconstr Surg. 2020 Sep;26(9):541-545. doi: 10.1097/SPV.0000000000000629.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): June 6, 2018

Study Registration Dates

• First Submitted: January 6, 2016
• First Submitted That Met QC Criteria: March 4, 2016
• First Posted (Estimate): March 7, 2016

Study Record Updates

• Last Update Posted (Actual): November 9, 2018
• Last Update Submitted That Met QC Criteria: November 6, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 15-092

Plan for Individual participant data (IPD)

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