Overview

This trial is active, not recruiting.

Condition prolapse of vaginal vault after hysterectomy
Treatment uterosacral ligament suspension colpopexy bilateral
Sponsor Kaiser Permanente
Collaborator Massachusetts General Hospital
Start date August 2011
End date April 2019
Trial size 800 participants
Trial identifier NCT01364025, PULS

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
uterosacral ligament suspension colpopexy sutures will be placed bilaterally at the time of hysterectomy
uterosacral ligament suspension colpopexy bilateral uterosacral ligament suspension at the time of hysterectomy
Uterosacral ligament suspension colpopexy bilateral
(No Intervention)

Primary Outcomes

Measure
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

Eligibility Criteria

Female participants at least 21 years old.

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.

Additional Information

Official title Prophylactic Uterosacral Ligament Suspension at the Time of Hysterectomy for Prevention of Vaginal Vault Prolapse (PULS)
Principal investigator Marianna Alperin, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Kaiser Permanente.