None listed
Conditions
Brief summary
Pelvic organ prolapse (POP) and stress urinary incontinence (SUI) affect many wahine in New Zealand. With synthetic mesh withdrawn due to safety concerns, current treatment uses autologous fascia, which some patients avoid due to harvest site morbidity. Cadaveric fascia and tendon grafts treated with supercritical CO2 offer a promising, ethically sourced, and non-toxic alternative already approved in Australia. This study aims to evaluate the safety, feasibility, and functional outcomes of these biologic implants for POP and SUI in a New Zealand clinical setting.
Interventions
Cadaveric fascia lata and tendon grafts treated with supercritical carbon dioxide (scCO2) for graft use in stress urinary incontinence and pelvic organ prolapse surgery
This trial is an opt=in trial with participants at three hospitals being offered participation. The two population groups listed below will be analysed together using patient reported outcomes measures which are standardised across all study participants.
There are two population groups in this study: 1) those requiring Fas
Cadaveric fascia lata and tendon grafts treated with supercritical carbon dioxide (scCO2) for graft use in stress urinary incontinence and pelvic organ prolapse surgery This trial is an opt=in trial with participants at three hospitals being offered participation. The two population groups listed below will be analysed together using patient reported outcomes measures which are standardised across all study participants. There are two population groups in this study: 1) those requiring Fascial sling surgery and 2) those requiring pelvic organ prolapse surgery. Fascial sling surgery will involve placement of the Web-assisted notification of device cadaveric fascia lata graft into the vagina. between the vaginal and the urethra. It is placed after the skin is opened. The pelvic organ prolapse surgery will involved placement of the web assited notification of device cadaveric fascia lata onto the vaginal fascia (underneath the skin) after the skin has been opened The surgery will be delivered by urologists. It will take 60-240 minutes. Medical records will be reviewed to ensure the graft is placed according to the study protocol
Sponsors
Eva Fong, Health NZ Waitemata
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria • Wahine aged 20–80 years • Symptomatic Stage II–IV POP and/or moderate–severe SUI (having tried conservative measures) • Failed conservative management (e.g., physiotherapy, pessary) • Able to provide informed consent for long-term follow-up • Patient will have undergone clinical assessment and chosen to undergo a stress incontinence procedure or pelvic organ prolapse procedure with a fascial graft. They will be offered then autologous fascia (harvest of own tissue) or participation in our study, cadaveric fascial graft
Exclusion criteria
• Immunosuppression • History of graft rejection • Prior pelvic radiation • Active pelvic infection • Patient preference to avoid cadaveric fascia
Outcome results
None listed