Clinical Research
Surgeons in South Africa are extremely well trained, and have a high case-load, meaning that they perform more surgery than the average surgeon. As a result, the clinical evaluation of innovative surgical procedures and new devices, is well placed in South Africa.
PFFSA has performed clinical studies in the field of urogynaecology, but has the infrastructure to organize clinical studies in other fields of surgery.
Previous clinical studies
A multicenter study was performed to evaluate the safety and efficacy of sacrospinous ligament fixation.
PFFSA is currently performing a “first in human safety study” to test a new biomaterial (to replace polypropylene) for the surgical correction of stress urinary incontinence.
On the background of the significant issues associated with synthetic slings that are currently being used for stress incontinence, we are currently in an advanced stage in the development of an absorbable TVT device. This ground-breaking research will provide women with incontinence with a much safer option.
PFFSA participates in a multi-center with the University of Amsterdam to compare 2 vaginal surgical procedures for the treatment of uterine prolapse.
Future Clinical Research
PFFSA is currently running a number of exciting projects that will bring new and innovative options to women with pelvic floor dysfunction. Most of the planned activities are confidential, as they involve the evaluation of devices that are not yet commercially available. Once we can disclose these studies, we will update our website.
PFFSA has almost finalized a safety study with P4HB in women with stress urinary incontinence, and we plan to initiate a multi-center study with hospitals in the US and Europe, to research if P4HB is similar efficacious in comparison to polypropylene. We also plan to research if P4HB can be used for (laparoscopic) sacrocolpopexy.
In clinical research we will continue to focus on the evaluation of innovative surgical procedures and devices. We aim to understand the added clinical value, the learning curve, the patient’s preference and attitude towards new technology, and the risk on adverse events.
Our tissue engineering research is planned to extend from “in vitro studies” and animal research, to first clinical studies. Currently we are working on thermo-sensitive hydrogels and other technologies to promote fibroblast activity. The bring tissue engineered solutions to human beings is one of our most ambitious goals.
If you would like more information or would like to collaborate with PFFSA, Contact us at info@pffsa.org
We are an internationally recognized research group working to improve the understanding and treatment of pelvic floor disorders and road back to pelvic health.
NPO Number: 168 916
Contact us:
Telephone:
+2782 2675 640
Email:
info@pffsa.org
Physical address:
Foreshore, Cape Town 8000
South Africa
