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uterosacral ligament suspension for Vaginal Vault Prolapse

N/A
Waitlist Available
Led By Marianna Alperin, MD
Research Sponsored by Kaiser Permanente
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year and annual thereafter for 5 years
Awards & highlights

Study 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.

Eligible Conditions
  • Vaginal Vault Prolapse

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year and annual thereafter for 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year and annual thereafter for 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: uterosacral ligament suspensionExperimental Treatment1 Intervention
uterosacral ligament suspension colpopexy sutures will be placed bilaterally at the time of hysterectomy
Group II: hysterectomy aloneActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalOTHER
2,928 Previous Clinical Trials
13,197,555 Total Patients Enrolled
Kaiser PermanenteLead Sponsor
538 Previous Clinical Trials
24,113,028 Total Patients Enrolled
Marianna Alperin, MDPrincipal InvestigatorKaiser Permanente

Frequently Asked Questions

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~59 spots leftby Apr 2025