Prophylactic Uterosacral Ligament Suspension at the Time of Hysterectomy for Prevention of Vaginal Vault Prolapse
|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.|
|ClinicalTrials.gov Identifier: NCT01364025|
Recruitment Status : Active, not recruiting
First Posted : June 2, 2011
Last Update Posted : May 21, 2015
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 or disease||Intervention/treatment||Phase|
|Prolapse of Vaginal Vault After Hysterectomy||Procedure: uterosacral ligament suspension colpopexy bilateral||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Prophylactic Uterosacral Ligament Suspension at the Time of Hysterectomy for Prevention of Vaginal Vault Prolapse (PULS)|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
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|
- 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 ]
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
|United States, California|
|Kaiser Permanente San Diego|
|San Diego, California, United States, 92110|
|Principal Investigator:||Marianna Alperin, MD||Kaiser Permanente|