Uterosacral Ligament Suspension vs Robotic Sacrocolpopexy

NCT02741830 | Completed

• 1 other identifier: 16-003
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

This cross sectional, two cohort study seeks to investigate both anatomic outcome and subjective, functional outcome of uterosacral ligament suspension versus robotic sacrocolpopexy and compare patient satisfaction, bladder function, sexual function and complication rate for each procedure.This study will provide a better understanding about the durability of these procedures and long term complication.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• Subject patient symptoms of prolapse, "bulge" symptom

  This is a binary outcome, and success is defined as answering "No" to question #3 on the Pelvic Organ Prolapse Distress Inventory (PFDI-20) questionnaire, as well as the absence of any reoperation or pessary use for pelvic organ prolapsed.

  3-7 years after reconstructive surgery involving uterosacral ligament suspension or robotic sacrocolpopexy

Study Arms (2)

Uterosacral ligament suspension (USLS)

This group of patients underwent the procedure of native tissue vaginal reconstructive surgery using uterosacral ligament suspension for pelvic organ prolapse.

Robotic sacrocolpopexy (RSC)

This group of patients underwent the reconstructive pelvic surgery of robotic sacrocolpopexy using synthetic mesh.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All women 18 years of age or older who underwent the uterosacral ligament suspension or robotic sacrocolpopexy for treatment of pelvic organ prolapse 3-7 years ago.

You may qualify if:

• Women aged 18 years of age or older who spent 3-7 years following uterosacral ligament suspension or robotic sacrocolpopexy.
• Concurrent procedures such as suburethral sling, bilateral salpingoophorectomy, hysterectomy, rectopexy.
• Concurrent procedures such a s takedown of sling

You may not qualify if:

• Concurrent procedure to remove vaginal mesh at time of their index surgery
• Unwillingness to participate in the study
• Dementia or inability to provide informed consent

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

Cincinnati Urogynecology Associates

Cincinnati, Ohio, 45220, United States

Location

Related Publications (1)

• Smith BC, Crisp CC, Kleeman SD, Yook E, Pauls RN. Uterosacral Ligament Suspension Versus Robotic Sacrocolpopexy for Treatment of Apical Pelvic Organ Prolapse. Female Pelvic Med Reconstr Surg. 2019 Mar/Apr;25(2):93-98. doi: 10.1097/SPV.0000000000000704.

  PMID: 30807407 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Rachel Pauls, MD

  TriHealth - Cincinnati Urogynecology Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: April 18, 2016
• Study Start: April 7, 2016
• Primary Completion: May 21, 2018
• Study Completion: October 16, 2018
• Last Updated: January 10, 2019

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)