Actively Recruiting

Age: 30Years - 100Years
FEMALE
ID05682989

Evaluation of Efficacy and Safety of Urogynecology Synthetic Mesh Surgery in Women With Pelvic Organ Prolapse

Led by Mackay Medical College · Updated on 2023-04-05

150

Participants Needed

1

Research Sites

230 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and safety of synthetic mesh surgery for pelvic organ prolapse in women. This retrospective cohort study focuses on different types of mesh surgeries, including transvaginal mesh and abdominal or laparoscopic sacrocolpopexy with mesh. The study aims to analyze recurrence and complication rates after these urogynecology mesh surgeries. The study involves reviewing data before and after surgery for women who underwent mesh procedures such as transvaginal mesh repair, robotic-assisted sacrocolpopexy using the DaVinci robotic system, and hysterectomy combined with transvaginal mesh repair. These procedures include detailed surgical techniques and urodynamic investigations conducted before and after surgery to assess urinary function. Participants will have pre-operative evaluations about 30 days before surgery and post-operative assessments within one year after surgery. These assessments include urodynamic studies and clinical examinations to monitor outcomes such as recurrence and complications. The study collects data retrospectively to measure the efficacy and safety of these surgical mesh treatments for pelvic organ prolapse in women.

CONDITIONS

Brief Title

Efficacy/Safety of Urogynecology Synthetic Mesh Surgery

Who Can Participate

Age: 30Years - 100Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pelvic organ prolapse patients with objective or subjective voiding dysfunctions
  • Underwent surgery for symptomatic pelvic organ prolapse stage II or higher according to POP-Q system
  • Female patients aged 30 to 100 years
Not Eligible

You will not qualify if you...

  • History of pelvic radiation
  • History of vesico-vaginal, recto-vaginal, or urethra-vaginal fistula
  • Unable to be followed up after surgery or treatment
  • Male patients
  • Patients younger than 30 or older than 100 years old
  • Patients without pelvic organ prolapse surgery for stage II or higher prolapse symptoms

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and immediate recovery period

Participants undergo one of the surgical procedures for pelvic organ prolapse using synthetic mesh, including trans-vaginal mesh repair, robotic-assisted sacrocolpopexy, or hysterectomy with trans-vaginal mesh repair.

1 surgery visit (in-person)

Post-operative Follow-up

Duration - Within 1 year after surgery

Participants have urodynamic investigations and clinical assessments after surgery to monitor recovery and evaluate outcomes.

Multiple follow-up visits within 1 year

Trial Site Locations

Total: 1 location

1

Department of Obstetrics and Gynecology

New Taipei City, Taiwan

Actively Recruiting

Loading map...

Research Team

H

Hui-Hsuan Lau, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

Similar Trials

A Multi-center Registry Study: The Complications After Women...

Pelvic Organ Prolapse

Actively Recruiting

1 location

Accelerometer Measured Early Recovery After Prolapse Surgery...

Pelvic Organ Prolapse

Actively Recruiting

7 locations

Feasibility Study on Laparoscopic Double-mesh Sacrocolpopexy...

Pelvic Organ Prolapse

Actively Recruiting

5 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Fourth International Consultation on Incontinence Recommendations of the International Scientific Committee: Evaluation and treatment of urinary incontinence, pelvic organ prolapse, and fecal incontinence.

P Abrams, K E Andersson, L Birder...

https://pubmed.ncbi.nlm.nih.gov/20025020

Updated Systematic Review and Meta-analysis of the Comparative Data on Colposuspensions, Pubovaginal Slings, and Midurethral Tapes in the Surgical Treatment of Female Stress Urinary Incontinence.

Ferdinando Fusco, Mohamed Abdel-Fattah, Christopher R Chapple...

https://pubmed.ncbi.nlm.nih.gov/28479203

A systematic review and meta-analysis of single-incision mini-slings (MiniArc) versus transobturator mid-urethral slings in surgical management of female stress urinary incontinence.

Binbin Jiao, Shicong Lai, Xin Xu...

https://pubmed.ncbi.nlm.nih.gov/29620645

Retropubic or transobturator mid-urethral slings for intrinsic sphincter deficiency-related stress urinary incontinence in women: a systematic review and meta-analysis.

Abigail A Ford, Joseph A Ogah

https://pubmed.ncbi.nlm.nih.gov/26220506