Advice

Clinical and technical evidence

Clinical and technical evidence

A literature search was carried out for this briefing in accordance with the interim process and methods statement for medtech innovation briefings. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting mibs@nice.org.uk.

Published evidence

Three studies are summarised in this briefing, including a total of 326 people.

One study is a randomised controlled trial comparing iTind with sham. The other 2 studies are single arm studies. One of the single arm studies has multiple publications for 1‑year (Porpiglia et al. 2019), 2‑year (Kadner et al. 2020) and 3‑year (Amparore et al. 2020) follow up and is summarised as 1 study.

There are further studies that are not summarised here including 1 study with 2 publications for 1‑year and 3‑year follow up (Porpiglia et al. 2015; Porpiglia et al. 2018) on the first generation Temporary Implantable Nitinol Device (TIND) and 1 narrative review (De Cillis et al. 2022) that summarised all the studies linked in this section. There is also a further long-term follow-up abstract published with data up to 79 months post treatment (Amparore et al. 2022).

The clinical evidence and its strengths and limitations is summarised in the overall assessment of the evidence.

Overall assessment of the evidence

The evidence for the technology is of low to moderate methodological quality. There is limited UK NHS evidence, and in the randomised controlled trial a sham was used as the comparator. Some of the evidence is on the TIND, which was the previous version of iTind. The evidence suggests that iTind improves symptoms and quality of life and is associated with expected, short-term, mild, transient and self‑resolving complications. Evidence on more comparative long-term patient outcomes would be beneficial.

Chughtai et al. (2020)

Intervention and comparator

iTind (second generation) compared with sham (18F silicon Foley catheter).

Key outcomes

A total of 175 men were randomised to either the iTind group (n=118) or the sham group (n=57). At 3 months, 78.6% of men in the iTind group showed a reduction in 3 or more points in the international prostate symptom score (IPSS) compared with 60% in the sham group (p=0.029). At 12 months, the iTind group reported a 9.25 point decrease in IPSS (p<0.0001), a 3.52 ml/s increase in peak urinary flow rate (p<0.0001) and a 1.9 point improvement in IPSS quality of life (p<0.0001). Adverse events were typically mild and transient in 38.1% of patients in the iTind arm and 17.5% in the control arm, most were Clavien-Dindo grade 1 or 2. No new ejaculatory or erectile dysfunction was reported.

Strengths and limitations

This study showed that iTind provided a sustained improvement in lower urinary tract symptoms during the 12‑month study period while preserving sexual function. Limitations included loss to follow up at the 3‑month visit (29% in the iTind group compared with 30% in the sham group) and limited generalisability because of the strict inclusion criteria. Unblinding happened at 3 months. The study was sponsored by Medi-Tate Ltd. The corresponding author is a consultant for Medi-Tate Ltd, Olympus, Boston Scientific and Medeon Bio.

Amparore et al. (2020)

Intervention and comparator

iTind (second generation), no comparator.

Key outcomes

At 3 years of follow up, data was available for 50 participants. Significant improvements from baseline (p<0.001) were found for IPSS score (58.2%), quality of life (55.6%), maximum urinary flow rate (114.7%) and post void residual urine (85.4%). These improvements in outcomes remained significant compared with the baseline values in the intention-to-treat analysis (p<0.001). All iTind implantations were successful with no intraoperative complications and with a median visual analogue scale pain score of 4. Participants were discharged without a catheter on the same day of the implantation. During the 12‑month follow up, 2 patients (2.4%) required further medical therapy and 2 patients (2.4%) required transurethral resection of the prostate, while 10 patients were lost to follow up (12.3%). No adverse events were recorded between 12 months and 36 months. Sexual function was stable throughout the 3‑year follow up, with no reports of sexual or ejaculatory dysfunction. No participants had alternative treatments between 24 months and 36 months.

Strengths and limitations

This paper reports the 3‑year results from this study. Kadner et al. (2020) reported 2‑year results and Porpiglia et al. (2019) reported 1‑year results. The authors concluded that this study showed that iTind showed a significant and durable reduction in symptoms and improvement in functional outcomes and quality of life at 3‑year follow up. Limitations include the lack of a control arm and potential selection bias because the study excluded people with a prostate volume of more than 75 ml and with post void residual urine of more than 250 ml. Fifty participants (62%) completed the 3‑year follow up.

De Nunzio et al. (2020)

Intervention and comparator

iTind (second generation), no comparator.

Key outcomes

Significant improvements from baseline (p<0.01) were found for IPSS (-12.7), IPSS quality of life (-2.2) and peak flow rate (4.6 ml/s). No significant changes in post void residual urine were found. At 6 months, erectile and ejaculatory function, and urinary continence were preserved in all 70 men and significantly improved according to the male sexual health questionnaire for ejaculatory dysfunction (MSHQ-EjD; p<0.01). Overall, 75 complications were detected in 70 patients. The most common complications (Clavien-Dindo grade 1) were transient haematuria (18.6%), dysuria (17%), urgency (12.8%), pain (11.4%), transient urinary incontinence (8.4%) and frequency (7%). Acute urinary retention occurred in 3 people (4.2%), 2 with the device in situ and one 12 hours after the device was removed. Only 1 patient presented a Clavien‑Dindo grade 3 complication (1.4%), specifically gross haematuria presenting a few days after iTind removal in a patient with a large prostate (80 g), needing endoscopic fulguration.

Strengths and limitations

This study suggested that iTind significantly improves symptoms, quality of life and urinary flow, and preserves erectile and ejaculatory function at 6‑month follow up. Limitations include a lack of a control arm, short follow up, no full use of the MSHQ questionnaire and lack of urodynamic data. The authors concluded that further comparative studies with longer follow up are needed. The study was sponsored by Medi-Tate. The authors declared that they had no conflict of interest. The company note that this is a preliminary report which will be followed up at 36 months on the whole 200 patient cohort.

Sustainability

iTind is a single use device and cannot be recycled. The iTind device should be disposed of safely according to local regulations.

Recent and ongoing studies