Evaluating the safety and effectiveness of synthetic mesh surgery for pelvic organ prolapse
Evaluation of Efficacy and Safety of Urogynecology Synthetic Mesh Surgery in Women With Pelvic Organ Prolapse
This study is testing how safe and effective synthetic mesh surgery is for women with severe pelvic organ prolapse to see how well it works and what problems it might cause.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 30 Years to 100 Years |
| Sex | Female |
| Sponsor | Mackay Medical College Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (New Taipei City) |
| Trial ID | NCT05682989 on ClinicalTrials.gov |
What this trial studies
This observational study analyzes the efficacy and safety of synthetic mesh surgery for women with pelvic organ prolapse, specifically focusing on Stage III and IV high-grade cases. It involves a retrospective cohort of patients who have undergone various surgical interventions, including transvaginal mesh and robotic-assisted laparoscopic sacrocolpopexy. The study aims to assess recurrence and complication rates associated with these procedures, providing valuable insights into their long-term outcomes. The findings will contribute to understanding the balance between surgical success and potential mesh-related complications.
Who should consider this trial
Good fit: Ideal candidates include women with symptomatic pelvic organ prolapse of Stage II or higher who experience voiding dysfunction.
Not a fit: Patients with a history of pelvic radiation or those unable to participate in follow-up will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical data to improve surgical outcomes and patient safety in pelvic organ prolapse treatments.
How similar studies have performed: Previous studies have indicated mixed results regarding the safety and efficacy of synthetic mesh in pelvic organ prolapse, highlighting the need for further evaluation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pelvic organ prolapse patients with objective / subjective voiding dysfunctions * Underwent surgery for symptomatic POP ≥ stage II (POP-Q system) Exclusion Criteria: * Patients with a history of pelvic radiation. * Patients with a history of vesico-/recto-/urethra-vaginal fistula * Patients unable to be followed up.
Where this trial is running
New Taipei City
- Department of Obstetrics and Gynecology — New Taipei City, Taiwan (Recruiting)
Study contacts
- Study coordinator: Hui-Hsuan Lau, M.D.
- Email: huihsuan1220@gmail.com
- Phone: +886-975-835928
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.