NCT02700997

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2018

Completed
5 months until next milestone

Results Posted

Study results publicly available

November 9, 2018

Completed
Last Updated

November 9, 2018

Status Verified

November 1, 2018

Enrollment Period

1.4 years

First QC Date

January 6, 2016

Results QC Date

October 8, 2018

Last Update Submit

November 6, 2018

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Vascular clip

EXPERIMENTAL

Application of a clip to dissolvable sutures.

Device: Vascular Clip

Interventions

Vascular ClipDEVICE

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

Also known as: Clip
Vascular clip

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Urogynecology Associates

Cincinnati, Ohio, 45220, United States

Location

Related Publications (1)

  • 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.

    PMID: 30180050DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Surgical Instruments

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and Supplies

Results Point of Contact

Title
Rachel Pauls MD
Organization
TriHealth Inc.
Rachel_Pauls@trihealth.com
513-463-4300

Study Officials

  • Rachel Pauls, MD

    TriHealth - Cincinnati Urogynecology Associates

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2016

First Posted

March 7, 2016

Study Start

March 1, 2016

Primary Completion

August 1, 2017

Study Completion

June 6, 2018

Last Updated

November 9, 2018

Results First Posted

November 9, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)