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Uterosacral Ligament Suspension vs Robotic Sacrocolpopexy

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ClinicalTrials.gov Identifier: NCT02741830
Recruitment Status : Completed
First Posted : April 18, 2016
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.

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.

Condition or disease
Pelvic Organ Prolapse

Detailed Description:

Pelvic organ prolapse is a common problem affecting many women and there is a 12.6% lifetime risk of undergoing reconstructive pelvic surgery. There are several surgical options available to patients undergoing reconstruction for pelvic organ prolapse, however addressing the apex is recommended to achieve the most durable outcomes. Two of the most commonly performed procedures for apical prolapse repair are uterosacral ligament suspension and robotic sacrocolpopexy.

High uterosacral ligament suspension is a native tissue repair which is performed by affixing the vaginal apex to the bilateral uterosacral ligaments using permanent or delayed-absorbable sutures. This is performed typically in a vaginal approach. Sacrocolpopexy is a performed by attaching the anterior and posterior vaginal walls to the sacral promontory using synthetic mesh, typically polypropylene. This procedure can be performed by an abdominal approach, a laparoscopic approach or with the assistance of the da Vinci robotic system. In recent years, robotic sacrocolpopexy has largely replaced the abdominal approach, and become the procedure of choice for minimally invasive surgeons.

Most studies evaluating sacrocolpopexy outcomes were performed prior to the popularity of robotics and therefore concentrate on abdominal sacrocolpopexy.

This cross sectional, two cohort study will compare outcomes of uterosacral ligament suspension versus robotic sacrocolpopexy and will give pelvic surgeons a better understanding about the durability of these procedures, and possible longer term complication rates.

Subjects will be contacted and asked to come to the office for a visit and completion of questionnaires. If they cannot come to the office, an Informed Consent Form (ICF) and questionnaires will be mailed to them to complete and return separately.

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Study Type : Observational
Actual Enrollment : 186 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Long Term Outcomes of Uterosacral Ligament Suspension Versus Robotic Sacrocolpopexy
Actual Study Start Date : April 7, 2016
Actual Primary Completion Date : May 21, 2018
Actual Study Completion Date : October 16, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Subject patient symptoms of prolapse, "bulge" symptom [ Time Frame: 3-7 years after reconstructive surgery involving uterosacral ligament suspension or robotic sacrocolpopexy ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02741830


Locations
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United States, Ohio
Cincinnati Urogynecology Associates
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
TriHealth Inc.
Investigators
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Principal Investigator: Rachel Pauls, MD TriHealth - Cincinnati Urogynecology Associates
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT02741830    
Other Study ID Numbers: 16-003
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical