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Prophylactic Uterosacral Ligament Suspension at the Time of Hysterectomy for Prevention of Vaginal Vault Prolapse

This study is currently recruiting participants.
Verified January 2013 by Kaiser Permanente
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Marianna Alperin, M.D. M.S., Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01364025
First received: May 31, 2011
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  Purpose

Is routine uterosacral ligament suspension an appropriate clinical adjunct at the time of hysterectomy?

The answers to these questions will facilitate the treatment of many American women. With the results of this study, the investigators would anticipate a reduction in the number of surgeries for pelvic organ prolapse. In addition, if uterosacral ligament suspension was shown to be ineffective, it would not be used routinely in the setting of hysterectomy and women will be spared the additional procedure and possibility of side effects or complications.

The relative risks and benefits of adding a prophylactic uterosacral ligament suspension at the time of hysterectomy in women without symptomatic prolapse symptoms have never been studied prospectively.


Condition Intervention
Prolapse of Vaginal Vault After Hysterectomy
 Procedure: uterosacral ligament suspension colpopexy bilateral

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prophylactic Uterosacral Ligament Suspension at the Time of Hysterectomy for Prevention of Vaginal Vault Prolapse (PULS)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • To compare the occurrence of objective findings of pelvic organ prolapse beyond hymen after uterosacral ligament suspension of the vaginal apex at the time of hysterectomy vs. hysterectomy alone using Pelvic Floor Quantitative Examination [ Time Frame: one year and annual thereafter for 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 168
Study Start Date: August 2011
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: uterosacral ligament suspension
uterosacral ligament suspension colpopexy sutures will be placed bilaterally at the time of hysterectomy
 Procedure: uterosacral ligament suspension colpopexy bilateral
Uterosacral ligament suspension colpopexy bilateral
Other Name: uterosacral ligament suspension at the time of hysterectomy
No Intervention: hysterectomy alone

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligibility for primary procedure (hysterectomy either total or supracervical, performed either vaginally or abdominally, via laparoscopic or open approach)
  • Eligibility for secondary procedure (uterosacral ligament suspension colpopexy)
  • Prolapse in any compartment not extending beyond the hymen as measured by Pelvic Organ Prolapse Quantitative system
  • No subjective complaints of Pelvic Organ Prolapse as determined by answer "no" to questions #3 of the short form of Pelvic Floor Distress Inventory: #3. Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?

Exclusion Criteria:

  • Contraindication for uterosacral ligament suspension colpopexy. (Surgeon's judgment that a contraindication to uterosacral ligament suspension colpopexy exists).
  • Anticipated geographic relocation within the 12 months after surgery
  • Inability to provide informed consent or to complete testing or data collection.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01364025

Contacts
Contact: Marianna Alperin, MD, MS 617-970-3164 malperin@ucsd.edu

Locations
United States, California
Kaiser Permanente West Los Angeles Recruiting
Los Angeles, California, United States, 90034
Contact: Marianna Alperin, MD, MS     323-857-2238     Mariann.X.Alperin@kp.org    
Principal Investigator: Marianna Alperin, MD, MS            
Sponsors and Collaborators
Kaiser Permanente
Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Marianna Alperin, M.D. M.S., Principal Investigator, Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01364025     History of Changes
Other Study ID Numbers: PULS
Study First Received: May 31, 2011
Last Updated: January 25, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 19, 2013