Evaluating the safety and effectiveness of synthetic mesh surgery for pelvic organ prolapse
Official title: Evaluation of Efficacy and Safety of Urogynecology Synthetic Mesh Surgery in Women With Pelvic Organ Prolapse
Run by Mackay Medical College · NCT05682989 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 30 Years to 100 Years |
| Sex | Women only |
| Enrollment | 150 (estimated) |
| Sponsor | Mackay Medical College Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (New Taipei City) |
| Status | Recruiting |
| Started | August 1, 2022 |
| Main results expected | August 1, 2023 |
| Study ends | December 31, 2027 |
| Registry record updated | April 5, 2023 |
| Trial ID | NCT05682989 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include women with symptomatic pelvic organ prolapse of Stage II or higher who experience voiding dysfunction.
✕Probably not a fit
Patients with a history of pelvic radiation or those unable to participate in follow-up will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have indicated mixed results regarding the safety and efficacy of synthetic mesh in pelvic organ prolapse, highlighting the need for further evaluation.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Improving Uroflowmetry: Do Pre-Procedure Reminders Help Women Undergoing Urodynamics
This study tests whether sending reminder calls before a urodynamics test helps women with pelvic floor disorders feel more prepared and less anxious, and whether it makes the procedure go more smoothly.
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Vaginal Vault Support at Hysterectomy
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Centered Surgery: Preoperative Counseling to Improve Patient Satisfaction
This study will test whether virtual group counseling sessions (shared medical appointments) help adults having pelvic organ prolapse surgery feel more satisfied and better prepared compared with standard individual phone calls.
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Pelvic floor muscle training with and without hypopressive exercises for women with pelvic organ prolapse
This will test whether adding hypopressive exercises to pelvic floor muscle training helps women aged 45–65 with stage I–II pelvic organ prolapse improve pelvic floor strength, reduce pain during sex, and feel better overall.
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Wrist activity tracking to guide early recovery after pelvic organ prolapse surgery
This study will try giving women having pelvic organ prolapse surgery either usual postoperative advice or a guided early-exercise plan while tracking activity with a wrist accelerometer to see which group reaches "mostly recovered" sooner.
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Mesh-free sacrocolpopexy using the VNOTES (transvaginal endoscopic) approach for pelvic organ prolapse
This trial will try mesh-free sacrocolpopexy using the VNOTES transvaginal endoscopic technique in women with stage II or higher pelvic organ prolapse to see if it improves pelvic support, symptoms, and sexual function over six months.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.