N/A
N=17
Uterosacral Ligament Suspension Clip
Pelvic Organ Prolapse
Bottom Line
View on ClinicalTrials.gov: NCT02700997 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Suture Location in Relation to the Surrounding Anatomy — 2.5; 2.8; 2.2; 2.2 cm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vascular Clip (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- TriHealth Inc.
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Suture Location in Relation to the Surrounding Anatomy |
2.5; 2.8; 2.2; 2.2; 2.4; 2.5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02700997). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.