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Uterosacral Ligament Suspension Clip (USLS)

Primary Purpose

Pelvic Organ Prolapse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vascular Clip
Sponsored by
TriHealth Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pelvic Organ Prolapse

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cincinnati Urogynecology Associates

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vascular clip

Arm Description

Application of a clip to dissolvable sutures.

Outcomes

Primary Outcome Measures

Suture Location in Relation to the Surrounding Anatomy
Measurement between internal iliac complex and proximal suture; measurement between ureter and proximal/distal suture.

Secondary Outcome Measures

Full Information

First Posted
January 6, 2016
Last Updated
November 6, 2018
Sponsor
TriHealth Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02700997
Brief Title
Uterosacral Ligament Suspension Clip
Acronym
USLS
Official Title
Uterosacral Ligament Suspension: A Radiographic Study of Anatomy and Suture Location
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
June 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TriHealth Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vascular clip
Arm Type
Experimental
Arm Description
Application of a clip to dissolvable sutures.
Intervention Type
Device
Intervention Name(s)
Vascular Clip
Other Intervention Name(s)
Clip
Intervention Description
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
Primary Outcome Measure Information:
Title
Suture Location in Relation to the Surrounding Anatomy
Description
Measurement between internal iliac complex and proximal suture; measurement between ureter and proximal/distal suture.
Time Frame
1 day after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Pauls, MD
Organizational Affiliation
TriHealth - Cincinnati Urogynecology Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Urogynecology Associates
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30180050
Citation
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.
Results Reference
derived

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Uterosacral Ligament Suspension Clip

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