Study to assess the efficacy of Medi-tate TIND in BPH
One-arm, multi-center, international prospective study to assess the efficacy of Medi-tate Temporary Implantable Nitinol Device (TINDTM) in subjects with Benign Prostatic Hypertrophy (BPH)
Benign prostatic hyperplasia (BPH) is a condition that prevents normal urine outlet and the symptoms usually appear in men above the age of 40, toward 50 years of age. Among the BPH men obstructive symptoms are poor pressure urinary flow, hesitancy in voiding and a sense of incomplete emptying. Among the BPH irritative symptoms are frequency of urination, urgency of urination, urge incontinence and nocturia. Generally, the irritative symptoms are those mostly likely to affect the patient’s quality of life. Selective drugs called alpha-blockers are able to relieve symptoms incompletely in 60-65% of patients. Side effects include postural hypotension, nasal congestion and retrograde ejaculation due to relaxation of the bladder neck sphincter. Many men are not happy with these drugs as long term management of their symptoms. During the past 15 years, a number of alternative technologies have been developed and marketed. If the prostates are small enough, they are best managed by bladder neck incision (Transurethral Incision of Prostate, TUIP) surgery, rather than formal resection of prostatic tissue that occurs in the gold standard treatment of today, namely Transurethral Resection of the Prostate (TURP). The fact that the TUIP requires general anesthesia and is quite unpleasant, means that more and more patients with BPH choose to use the alpha blockers to the point of no choice, and then require the TURP. This trial is to assess the efficacy of Medi-Tate’s Temporary Implantable Nitinol Device (TIND) in patients who do not benefit from the alpha blockers anymore, who prefer not to take drugs and wish to avoid the more risky and demanding TURP. More than 35 subjects have already been implanted with this CE approved device that demonstrated an excellent safety profile and remarkable improvement in the International Prostate Symptom Score (IPSS) and peak uroflow.
London - Bromley Research Ethics Committee
Date of REC Opinion
12 Jun 2014
Further Information Favourable Opinion