PDS Versus Prolene as Suture Material for Vaginal Sacrospinous Hysteropexy

Launched by MEDICAL UNIVERSITY OF VIENNA · Jul 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the best type of suture material to use during a specific surgery called sacrospinous hysteropexy, which helps treat pelvic organ prolapse. Pelvic organ prolapse is a common condition where pelvic organs, such as the uterus, drop down into the vagina, causing discomfort and other symptoms. The trial compares two types of sutures: absorbable sutures (which dissolve over time) and non-absorbable sutures (which do not dissolve). The main goal is to see which type of suture leads to better improvement in symptoms one year after the surgery.

Women aged 65 to 75 who are planning to have this surgery for certain types of prolapse may be eligible to participate. To qualify, participants must have specific types of prolapse and experience symptoms like a vaginal bulge. Those with previous surgeries for prolapse or certain health conditions may not be eligible. Participants can expect to be randomly assigned to receive either type of suture, and their progress will be monitored over a year to assess their symptoms and quality of life. The findings from this study will help doctors understand which suture is more effective for this surgery, and the results will be shared in medical journals and meetings.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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 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