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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01364025
First Posted: June 2, 2011
Last Update Posted: May 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Kaiser Permanente
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


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 ]

Estimated Enrollment: 800
Study Start Date: August 2011
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes 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
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): NCT01364025


Locations
United States, California
Kaiser Permanente San Diego
San Diego, California, United States, 92110
Sponsors and Collaborators
Kaiser Permanente
Massachusetts General Hospital
Investigators
Principal Investigator: Marianna Alperin, MD Kaiser Permanente
  More Information

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01364025     History of Changes
Other Study ID Numbers: PULS
First Submitted: May 31, 2011
First Posted: June 2, 2011
Last Update Posted: May 21, 2015
Last Verified: May 2015

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