NCT01364025

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: Female
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prolapse of Vaginal Vault After Hysterectomy

Interventions

Type	Name	Description
PROCEDURE	uterosacral ligament suspension colpopexy bilateral	Uterosacral ligament suspension colpopexy bilateral

Timeline

• Start date: 2011-08-01
• Primary completion: 2021-02-21
• Completion: 2021-02-21
• First posted: 2011-06-02
• Last updated: 2020-02-25

Locations

1 site across 1 country: United States