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Is Nitinol Device an Effective Treatment for Benign Prostatic Hyperplasia Patients?


Clinical trial finds Nitinol device is safe and effective treatment for men with benign prostatic hyperpasia

Benign prostatic hyperplasia (BPH), one of the most common diseases affecting men as they age, often causes lower urinary tract symptoms (LUTS) that can negatively affect daily activities and quality of life (QoL). There are many treatments available for BPH, some of which may cause sexual dysfunction.

Benign prostatic hyperplasia, a noncancerous enlargement of the prostate gland, is the most common benign tumor found in men. It can cause a variety of symptoms such as LUTS, urinary retention, hematuria, and recurrent urinary tract infections. Treatments for BPH include pharmacotherapy and the current gold standard of transurethral resection of the prostate (TURP).

However, both are associated with a significant risk to sexual function. Since sexual health is a highly important aspect of QoL, newer techniques are being discovered aimed at preserving sexual function in BPH patients. One such option is a temporarily implanted nitinol device. It is a mechanical device that re-models the bladder neck and prostatic urethra by self-expansion.

Clinical Trial

A clinical trial evaluated the effectiveness of a temporarily implanted Nitinol device in treating LUTS and its impact on sexual function.

The trial, published in the Journal of Endourology, involved 185 men with BPH who were treated either with a Nitinol device or a similar non-effective procedure. The device was inserted into the prostate through the urethra and temporarily expanded to relieve pressure on the urethra and improve urine flow.

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The researchers evaluated the men's sexual function before and after the procedure using the Sexual Health Inventory for Men (SHIM) and International Index of Erectile Function (IIEF) scores.

The results of the clinical trial indicated that there were no differences in the sexual and ejaculatory scores in both groups compared to the baseline at 3 and 12 months after treatment.

This clinical trial is significant because it provides evidence that the Nitinol device not only improves LUTS in men with BPH but also does not negatively affect their sexual function. This finding is important because many men undergoing BPH treatment also experience sexual dysfunction, and this can have a negative impact on their overall quality of life.
The Nitinol device offers a minimally invasive treatment option for men with BPH that can improve their urinary symptoms without adversely affecting their sexual function.


The use of the Nitinol device is a safe and effective treatment option for men with LUTS secondary to BPH. It improves their urinary function without causing sexual dysfunction. Men who are experiencing symptoms of BPH should discuss their treatment options with their healthcare provider to determine if the Nitinol device is right for them.
Journal of Endourology, Dec-27-22
Clinicaltrials.gov: NCT02506465

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This content is for informational and educational purposes only. It is not intended to provide medical advice or to take the place of such advice or treatment from a personal physician. All readers/viewers of this content are advised to consult their doctors or qualified health professionals regarding specific health questions. CenTrial Data Ltd. does not take responsibility for possible health consequences of any person or persons reading or following the information in this educational content. Treatments and clinical trials mentioned may not be appropriate or available for all trial participants. Outcomes from treatments and clinical trials may vary from person to person. Consult with your doctor as to whether a clinical trial is a suitable option for your condition. Assistance from generative AI tools may have been used in writing this article.