Last updated: August 30, 2023
Sponsor: Medical University of Vienna
Overall Status: Active - Recruiting
Phase
N/A
Condition
Genitourinary Prolapse
Treatment
sacrospinous hysteropexy
Clinical Study ID
NCT05964881
2079
Ages 18-100 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Anterior vaginal wall prolapse beyond the hymen (POP-Q-point Aa or Ba >0) with centraldefect
- Prolapse of the apical vaginal vault beyond the hymen (POP-Q point C >0) with centraldefect
- Symptoms of a vaginal bulge
- A primary reconstructive operation using sacrospinous hysteropexy is planned
Exclusion
Exclusion Criteria:
- 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
Study Design
Total Participants: 52
Treatment Group(s): 1
Primary Treatment: sacrospinous hysteropexy
Phase:
Study Start date:
May 15, 2023
Estimated Completion Date:
December 31, 2025
Connect with a study center
Medical University of Vienna
Vienna, 1090
AustriaActive - Recruiting


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