Wings for Life clinical trial
Important announcement of Wings for Life concerning the Bladder Pacemaker Trail (LION technique) in Patients following chronic Spinal Cord Injury (SCI).
The Wings for Life foundation would like to clarify the following concerning its recent promotion of the technique of Prof. Marc Possover which consists of a Laparoscopic Implantation Of Neuroprothesis (LION procedure) to pelveo-abdominal nerves for the recovery of bladder/intestinal/sexual functions in paralyzed patients (Possover et al., 2010).
It is thereby important to highlight the following facts:
1) This technique has passed a successful Pilot study and is not yet meeting the criteria of an effective intervention according to the needs of Evidence Based Medicine (EBM). In the pilot trial, Prof. Possover did some test implantation to develop the stimulation procedure and these tests gave only positive results without any secondary complications. The clinical trial that will prove a full efficacy of this method, without any secondary complications is about to begin and will require a several years follow-up to ensure that the method is stable and safe over a long period of time.
2) Since the technique has not yet been proven by higher grade clinical trial (e.g. Phase IIb) no other institution should start this kind of implantation and it is thereby unnecessary that patients who would potentially benefit from this procedure request to their treating doctors / institution to receive this kind of stimulation device. Once the clinical trial is complete and that the method is confirmed this technique might become the golden standard of treatment, but should not be used before then.
3) The intended trial does not interfere or represent an alternative to your present treatment.
More information about the study of Prof. Possover will be available on the Wings for Life homepage in a near future. We wish Prof. Possover and his team to succeed in this trial and succeed in bringing this new technique to the numerous spinal cord injured patients that might benefit from it.
Wings for Life.
Article: Possover et al., 2010. New strategies of pelvic nerves stimulation for recovery of pelvic visceral functions and locomotion in paraplegics. Neurourology and Urodynamics, in press.
Innovative surgery for spinal cord injured patients: a minimal invasive surgery approach for the implantation of novel bladder-pacemaker - A pilot trial.
Prof. Possover, MD is the Chairman of the Dept of Neuropelveology in Zürich at the “Klinik Hirslanden” (Switzerland) and developed an innovative surgical approach in order to improve the bladder activity, the intestinal and sexual functions in paralyzed patients: LION (for Laparoscopic Implantation of Neuroprothesis). The novelty of this approach lies in its minimally invasive nature. Thus, it does not lead to any irreversible destruction of nerves and shortens hospitalization periods of the patient. The microelectrodes implanted and fixed in direct apposition to the nerves are controlled by the patient externally using a remote control unit. This enables bladder voiding and bowel movements as well as recovering sexual functions (for male patients). Within a pilot trial headed by Prof. Possover, thirteen complete paralyzed patients were treated by this method. All patients recovered bladder and intestinal functions to variable degrees. Prof. Possover is an internationally recognized pioneer in the field of laparoscopic surgery targeting the selective stimulation of the pelvic nerves. He successfully performed many new types of pelvic implantation for the first time. By this approach, patients may gain both function and freedom which could substantially and persistently improve their quality of life.
Wings for Life funded this pilot trial in order to validate this novel surgical approach. To date, no serious side effects have been reported in the thirteen patients being enrolled. Wings for Life is funding a continuation of this trial in which a new system that will combine the previous bladder/intestinal/sexual control will be implanted together with an additional stimulation electrode. This aims to increase legs muscle mass and skin blood flow, thereby preventing one additional devastating consequence of spinal cord injury: pressure ulcers. The results have been published in an international journal (J Minim Invasive Gynecol. 2009, 16:98-101) and are thereby accessible by treating physicians.
This is the first clinical trial funded by Wings for Life and an example of effective, translational and transparent research leading towards an improved quality of life.
Please find an important note HERE.
More information can be found on Prof. Marc Possover homepage.
