Comparing two types of sutures for pelvic organ prolapse surgery
PDS (Polydiaxonene Suture) Versus Prolene (Polypropylene Suture) as Suture Material for Vaginal Sacrospinous Hysteropexy - a Randomised Controlled Study
This study is testing whether using absorbable or non-absorbable sutures during pelvic organ prolapse surgery helps women feel better after the procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Female |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT05964881 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of absorbable PDS sutures versus non-absorbable Prolene sutures in sacrospinous hysteropexy, a surgical procedure for treating pelvic organ prolapse. It is a randomized, single-center superiority trial conducted at the Medical University of Vienna. The study will evaluate subjective symptom improvement in women undergoing this procedure, focusing on the type of suture material used. By standardizing the surgical technique, the study seeks to provide valuable data on the optimal choice of suture for this common gynecological condition.
Who should consider this trial
Good fit: Ideal candidates are women with anterior vaginal wall prolapse or apical vaginal vault prolapse who are planning to undergo a primary reconstructive operation using sacrospinous hysteropexy.
Not a fit: Patients with recurrent prolapse, a history of hysterectomy, or those requiring mesh or obliterative surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and symptom relief for women suffering from pelvic organ prolapse.
How similar studies have performed: While there is ongoing debate regarding the choice of suture material in similar surgical procedures, this study aims to provide the first comparative data on the effectiveness of absorbable versus non-absorbable sutures in this specific context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vienna
- Medical University of Vienna — Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Greta L Carlin, MD — Medical University of Vienna
- Study coordinator: Greta L Carllin, MD
- Email: greta.carlin@muv.ac.at
- Phone: +43-1-40400-28220
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.