LION Method (invasive surgery approach for the implantation of novel bladder-pacemaker) – pilot trial
Funded in: 2009
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Prof. Possover, MD is the Chairman of the Dept of Neuropelveology in Zurich at the “Klinik Hirslanden” (Switzerland) and developed a surgical approach in order to improve the bladder activity, the intestinal and sexual functions in paralyzed patients: LION (for Laparoscopic Implantation of Neuroprothesis).
This minimally invasive approach does not lead to 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.
The aim is to enable bladder voiding and bowel movements as well as recovering sexual functions (for male patients).
Within a pilot trial headed by Prof. Possover, several complete paralyzed patients were treated by this method. The patients recovered bladder and intestinal functions to variable degrees, severe secondary complications were not reported to date.
Wings for Life in general voted for funding the next step, a clinical trial, but only provided that a complete study protocol and an ethical approval are presented. This trial has to prove a full efficacy of the method and requires a perennial follow up of the patients.
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 in matters of its recent promotion of the technique of Prof. 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. Now this pilot study is closed. The next step, a clinical trial that will prove a full efficacy of this method without any secondary complications has to be started and will require a perennial 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 standard of treatment, but should not be used before then.
3) The intended trial does not interfere or represent an alternative to patients’ present treatment.
Ref: Andersson, KD. 2004. Targeting recovery: priorities of the spinal cord-injured population. J Neurotrauma. 21: 1371-83 Possover et al., 2010. New strategies of pelvic nerves stimulation for recovery of pelvic visceral functions and locomotion in paraplegics. Neurourology and Urodynamics 29:1433-1438