Back to resultsProphylactic Uterosacral Ligament Suspension at the Time of Hysterectomy for Prevention of Vaginal Vault Prolapse
Primary Purpose
Prolapse of Vaginal Vault After Hysterectomy
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
uterosacral ligament suspension colpopexy bilateral
Sponsored by
About this trial
This is an interventional prevention trial for Prolapse of Vaginal Vault After Hysterectomy
Eligibility 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.
Sites / Locations
- Kaiser Permanente San Diego
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
uterosacral ligament suspension
hysterectomy alone
Arm Description
uterosacral ligament suspension colpopexy sutures will be placed bilaterally at the time of hysterectomy
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01364025
First Posted
May 31, 2011
Last Updated
February 21, 2020
Sponsor
Kaiser Permanente
Collaborators
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01364025
Brief Title
Prophylactic Uterosacral Ligament Suspension at the Time of Hysterectomy for Prevention of Vaginal Vault Prolapse
Official Title
Prophylactic Uterosacral Ligament Suspension at the Time of Hysterectomy for Prevention of Vaginal Vault Prolapse (PULS)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
February 21, 2021 (Anticipated)
Study Completion Date
February 21, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prolapse of Vaginal Vault After Hysterectomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
uterosacral ligament suspension
Arm Type
Experimental
Arm Description
uterosacral ligament suspension colpopexy sutures will be placed bilaterally at the time of hysterectomy
Arm Title
hysterectomy alone
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
uterosacral ligament suspension colpopexy bilateral
Other Intervention Name(s)
uterosacral ligament suspension at the time of hysterectomy
Intervention Description
Uterosacral ligament suspension colpopexy bilateral
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianna Alperin, MD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Prophylactic Uterosacral Ligament Suspension at the Time of Hysterectomy for Prevention of Vaginal Vault Prolapse
We'll reach out to this number within 24 hrs