What is this study trying to find out about pelvic organ prolapse?

This study is examining the effectiveness and safety of synthetic mesh surgeries used to treat pelvic organ prolapse in women. It looks at different surgical techniques and aims to understand recurrence and complication rates. The research is sponsored by Mackay Medical College to help improve treatment approaches.

Who may be eligible for this pelvic organ prolapse clinical trial?

Women aged 30 to 100 years with pelvic organ prolapse and voiding dysfunction who have undergone surgery for symptomatic prolapse stage II or higher may be eligible. Those with a history of pelvic radiation or certain fistulas are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this pelvic organ prolapse clinical trial?

Study-related care, including data collection and evaluations, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Age: 30Years - 100Years

FEMALE

ID05682989

Study of Safety and Effectiveness of Synthetic Mesh Surgery for Pelvic Organ Prolapse in Women

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

150

Participants Needed

Research Sites

230 weeks

Total Duration

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

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

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

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