Status:

UNKNOWN

PDS Versus Prolene as Suture Material for Vaginal Sacrospinous Hysteropexy

Lead Sponsor:

Medical University of Vienna

Conditions:

Pelvic Organ Prolapse

Prolapse

Eligibility:

FEMALE

18-100 years

Phase:

NA

Brief Summary

Introduction: Pelvic organ prolapse is a common gynecological disease, which about 50% of women develop in the course of their lives. There are many different options for surgical care, e.g. the uteru...

Eligibility Criteria

Inclusion

  • Anterior vaginal wall prolapse beyond the hymen (POP-Q-point Aa or Ba \>0) with central defect
  • Prolapse of the apical vaginal vault beyond the hymen (POP-Q point C \>0) with central defect
  • Symptoms of a vaginal bulge
  • A primary reconstructive operation using sacrospinous hysteropexy is planned

Exclusion

  • Recurrent prolapse
  • History of hysterectomy
  • A primary reconstructive operation with mesh or obliterative surgery is planned
  • An operation with hysterectomy is planned
  • Known pelvic malignancy
  • Known inflammatory disease
  • Current systemic treatment with glucocorticoids or immunosuppressants
  • The subject cannot or does not want to participate

Key Trial Info

Start Date :

May 15 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

52 Patients enrolled

Trial Details

Trial ID

NCT05964881

Start Date

May 15 2023

End Date

December 1 2025

Last Update

September 5 2023

Active Locations (1)

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Medical University of Vienna

Vienna, Austria, 1090

PDS Versus Prolene as Suture Material for Vaginal Sacrospinous Hysteropexy | DecenTrialz