Interventional procedure overview of prostatic urethral temporary implant insertion for lower urinary tract symptoms caused by benign prostatic hyperplasia
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Safety summary
Overall
There were 16 serious adverse events within 30 days of the procedure in 10 (8%) patients who had a temporary implant inserted and 2 serious adverse events in 2 (4%) patients who had a sham procedure in the randomised controlled trial of 185 patients. Serious procedure-related events were reported in 3 (2%) patients in the implant group (5 events). In total, there were 109 adverse events in 45 (38%) patients in the implant group, of which 81 were procedure related (Chughtai, 2021).
Dysuria
Dysuria within 30 days of the procedure was reported in 23% (27/118) of patients who had a temporary implant inserted and 9% (5/57) of patients who had a sham procedure in the randomised controlled trial of 185 patients (Chughtai, 2021).
Dysuria within 1 month of the procedure was reported in 7% (6/81) of patients in the single-arm trial of 81 patients (Amparore, 2021).
Dysuria was reported in 17% (12/70) of patients in the single-arm trial of 70 patients (De Nunzio, 2020).
Haematuria
Haematuria within 30 days of the procedure was reported in 14% (16/118) of patients who had a temporary implant inserted and no patients who had a sham procedure in the randomised controlled trial of 185 patients (Chughtai, 2021).
Haematuria within 1 month of the procedure was reported in 12% (10/81) of patients in the single-arm trial of 81 patients (Amparore, 2021).
Transient haematuria was reported in 19% (13/70) of patients in the single-arm trial of 70 patients. In addition, 1 patient had gross haematuria that was treated by endoscopic fulguration (De Nunzio, 2020).
Urinary urgency within 30 days of the procedure was reported in 5% (6/118) of patients who had a temporary implant inserted and 1 patient who had a sham procedure in the randomised controlled trial of 185 patients (Chughtai, 2021).
Urgency within 1 month of the procedure was reported in 11% (9/81) of patients in the single-arm trial of 81 patients (Amparore, 2021).
Urgency was reported in 13% (9/70) of patients in the single-arm trial of 70 patients (De Nunzio, 2020).
Urinary frequency
Urinary frequency syndrome within 30 days of the procedure was reported in 7% (8/118) of patients who had a temporary implant inserted and 1 patient who had a sham procedure in the randomised controlled trial of 185 patients (Chughtai, 2021).
Frequency was reported in 7% (5/70) of patients in the single-arm trial of 70 patients (De Nunzio, 2020).
Urinary incontinence
Transient urinary incontinence while the device was in place was reported in 8% (6/70) of patients in the single-arm trial of 70 patients (De Nunzio, 2020).
Urinary incontinence because of device displacement was reported in 1 patient in the single-arm trial of 32 patients. This resolved after the device was removed on day 1 after insertion (Porpiglia, 2018).
Urinary retention
Urinary retention within 30 days of the procedure was reported in 6% (7/118) of patients who had a temporary implant inserted and no patients who had a sham procedure in the randomised controlled trial of 185 patients. In addition, 1 patient had urinary retention between 1 and 3 months after implant insertion (Chughtai, 2021).
Urinary retention within 1 month of the procedure was reported in 10% (8/81) of patients in the single-arm trial of 81 patients (Amparore, 2021).
Acute urinary retention was reported in 4% (3/70) of patients in the single-arm trial of 70 patients, all of whom had treatment with temporary catheterisation (De Nunzio, 2020).
Urinary retention on the same day as device implantation was reported in 1 patient in the single-arm trial of 32 patients (Porpiglia, 2018).
Infection
Urinary tract infection within 30 days of the procedure was reported in 2% (2/118) of patients who had a temporary implant inserted and no patients who had a sham procedure in the randomised controlled trial of 185 patients. One patient who had a temporary implant inserted had urinary tract infection between 1 and 3 months after implant insertion. The other patient had a urinary tract infection between 3 and 12 months after implant insertion. In the same study, sepsis within 30 days of the procedure was reported in 1 patient who had a temporary implant inserted (Chughtai, 2021).
Urinary tract infection within 1 month of the procedure was reported in 6% (5/81) of patients in the single-arm trial of 81 patients (Amparore, 2021).
Genitourinary infection within 30 days of the procedure was reported in 6% (2/32) of patients in the single-arm trial of 32 patients, both of whom had treatment with antibiotics (Porpiglia, 2018).
Pain
Pain within 30 days of the procedure was reported in 1 patient who had a temporary implant inserted and no patients who had a sham procedure in the randomised controlled trial of 185 patients (Chughtai, 2021).
Pain within 1 month of the procedure was reported in 10% (8/81) of patients in the single-arm trial of 81 patients (Amparore, 2021).
Need for further treatment
Two patients had TURP or laser treatment (not further described) within 1 month of the primary procedure in the single-arm trial of 81 patients. A further 5 patients (6%) had TURP or laser treatment 1 to 12 months after the primary procedure (Amparore, 2021).
Anecdotal and theoretical adverse events
In addition to safety outcomes reported in the literature, professional experts are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never happened).
For this procedure, professional experts did not describe any additional anecdotal or theoretical adverse events.
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