Evaluating the iTind temporary device for the treatment of lower urinary tract symptoms in patients with benign prostatic hyperplasia.

This study looked at the use of a temporarily implanted nitinol device (iTind) for the treatment of lower urinary tract symptoms (LUTS) in patients with benign prostatic hyperplasia (BPH). The authors found that iTind reduced LUTS and preserved sexual function in patients with BPH. 

BPH is the non-cancerous increase in the size of the prostate gland. BPH can lead to urinary and sexual symptoms that significantly impact the quality of life of patients. Most non-drug therapies involve the removal of a piece of the prostate that blocks urine flow by different modalities. These procedures have side effects such as erectile dysfunction. LUTS can be measured using the International Prostate Symptoms Score (IPSS). 

The iTind device is inserted into the prostate tissue where it remodels the prostate tissue blocking urine flow to reduce LUTS. The device is then completely removed following 5-7 days. Previous studies have shown that iTind has been effective in providing a reduction in LUTS with low side effect rates and preservation of sexual function. However, no studies have compared iTind to a placebo device until now. 

There were a total of 175 patients with BPH and LUTS who participated in this trial. 118 underwent iTind insertion. The remaining 57 patients underwent a placebo procedure. Participants were followed up for 12 months. 

After 3 months, 78.6% of patients in the iTind group had a 3-point or greater improvement in LUTS (on the IPSS scale). This was compared to 60% of patients in the placebo group. At 12-months there was a 9.25 IPSS decrease in the iTind group. Quality of life was improved in the iTind arm at 12 months. This improvement was not seen in the placebo group. There was no decline in sexual function in either group. 

38.1% of the iTind group experienced side effects compared to 17.5% in the placebo group. Most of these were mild and resolved within 1-4 days. These included pain during urination and bloody urine. No erectile dysfunction was reported.

The authors found that treatment with the iTind device provided a rapid improvement in LUTS while preserving sexual function. 

This trial was sponsored by Medi-Tate Ltd, the manufacturers of the iTind device. There was a high rate of follow-up loss in this trial at 3-month follow-up.