Interventional procedure overview of prostatic urethral temporary implant insertion for lower urinary tract symptoms caused by benign prostatic hyperplasia
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Summary of key evidence on prostatic urethral temporary implant insertion for lower urinary tract symptoms caused by benign prostatic hyperplasia
Study 1 Chughtai B (2021)
Study type | Randomised controlled trial |
|---|---|
Country | US and Canada (16 sites) |
Recruitment period | 2015 to 2018 |
Study population and number | n=185 (128 prostatic urethral temporary implant, 57 sham control) Men with symptomatic BPH |
Age | Mean 61.5 years (implant group), 60.1 years (sham group), p=0.1284 |
Patient selection criteria | Inclusion criteria: men 50 years or older, IPSS 10 or higher, peak urinary flow rate 12 mL/sec or less with a 125 mL voided volume, prostate volume between 25 and 75 cc, and normal urinalysis, complete blood count, and biochemistry. Excluded patients had a PVR volume more than 250 mL, obstructive median lobe, prostate specific antigen higher than 10 ng/ml or free PSA less than 25%, without a subsequent negative prostate biopsy, previous prostate surgery, prostate or bladder cancer, neurogenic bladder or sphincter abnormalities, or confounding bladder pathologies based on medical history, recent cystolithiasis or haematuria, active urinary tract infection, compromised renal function, severe respiratory disorders, known immunosuppression, active antithrombotic or antiplatelet treatment, cardiac disease, including arrhythmias and uncontrolled diabetes mellitus. |
Technique | Device: second generation iTind (Medi-Tate Ltd, Israel) The sham procedure was the insertion and removal of an 18F silicon Foley catheter to simulate both the implantation and retrieval procedures. Throughout the procedure, the surgeon gave verbal description as if deploying the iTind device, after which the catheter was removed. A similar protocol was followed for the removal. Although the iTind device was deployed through a rigid cystoscope, a Foley catheter was used to minimise the risk of procedure-related morbidity. Patients in both the device and control groups were draped to prevent them from seeing the treating physician and the device. All patients on BPH-related medications started a wash-out period before implantation: 1 month for alpha-blockers and 6 months for 5-alpha-reductase inhibitors. |
Follow up | 12 months |
Conflict of interest/source of funding | The study was sponsored by Medi-Tate Ltd. The corresponding author is a consultant for Medi-Tate Ltd, Olympus, Boston Scientific, and Medeon Bio. |
Analysis
Follow up issues: Of the 128 patients randomised to have temporary implant insertion, 10 did not have the procedure. At the 3-month follow up, data was missing for 29% (34/118) of patients in the implant group and 28% (16/57) of patients in the control group. Of the 118 patients who had a temporary implant inserted, 12‑month data was analysed for 78 (66%).
Study design issues: Prospective, randomised, controlled, multicentre, single-blinded study. Patients were randomised in 2:1 ratio to either temporary implant or control groups using permuted blocks stratified by centre by using a central electronic data program. The primary endpoint compared the percentage of patients with a reduction of at least 3 points in IPSS at 3 months between the groups. Unblinding of the sham arm was done at 3 months. Intention-to-treat analysis was used at 3 months and per protocol at 6 months. A sample size of 180 patients was estimated to provide at least 85% power to meet the study primary endpoint (with an expected response rate of 75% in the implant group and 51% in the sham group).
Study population issues: Baseline characteristics were similar among the 2 groups, except for the Charlson Comorbidity Index, with the implant group having a higher score (2.52 compared with 1.26, p<0.001).
Key efficacy findings
Number of patients analysed: 185 (128 prostatic urethral temporary implant insertion, 57 sham control)
Improvement in IPSS of 3 points or more at 3 months (intent-to-treat)
Implant group=78.6%
Control group=60%, p=0.029
Improvement in IPSS of 7 points or more at 3 months (intent-to-treat)
Implant group=72.6%
Control group=50%, p=0.048
97% of patients that responded to treatment at 3 months remained responders at 12 months.
Mean improvement in IPSS at 3 months (intent-to-treat)
Implant group= -9.0 (SD 8.5)
Control group= -6.6 (SD 9.5), p=0.063
Improvement in IPSS quality of life score from baseline to 3 months (intent-to-treat)
Implant group=reduction from 4.6 (SD 1.3) to 2.7 (SD 1.8) at 3 months
Control group=reduction from 4.9 (SD 1.0) to 3.4 (SD 2.0) at 3 months, p=0.264
Improvement in peak urinary flow rate from baseline to 3 months (intent-to-treat)
Implant group=improved from 8.7 (SD 3.3) ml/sec to 13.1 (SD 7.1) ml/sec
Control group=improved from 8.5 (SD 2.4) ml/sec to 11.4 (SD 5.3) ml/sec, p=0.230
Improvement in PVR volume from baseline to 3 months (intent-to-treat)
Implant group=decreased from 60.78 (SD 56.35) ml to 59.44 (SD 56.43) ml
Control group=increased from 61.9 (SD 54.2) ml to 66.9 (SD 65.1) ml, p=0.781
Outcome | n (paired) | baseline | follow up | change | 95% CI | p value |
|---|---|---|---|---|---|---|
IPSS Urinary Symptoms Score | 96 | 22.37 (6.92) | 12.80 (7.40) | -9.57 (8.29) | -11.3 to -7.9 | <0.0001 |
IPSS Quality of life | 96 | 4.66 (1.31) | 2.83 (1.88) | -1.83 (1.97) | -2.2 to -1.4 | <0.0001 |
Qmax (mL/second) | 73 | 8.01 (2.21) | 13.33 (10.50) | 5.32 (10.33) | 2.9 to 7.7 | <0.0001 |
PVR (mL) | 73 | 65.08 (60.66) | 49.90 (55.82) | -15.26 (63.88) | -30.3 to -0.3 | 0.0244 |
SHIM score | 96 | 12.92 (7.49) | 12.83 (8.06) | -0.10 (7.00) | -1.5 to 1.3 | 0.8165 |
IIEF score | 96 | 36.86 (20.04) | 40.31 (22.40) | 3.47 (18.56) | -0.4 to 7.3 | 0.0738 |
Outcome | n (paired) | baseline | follow up | change | 95% CI | p value |
|---|---|---|---|---|---|---|
IPSS Urinary Symptoms Score | 80 | 22.38 (6.84) | 12.57 (6.95) | -9.48 (8.49) | -11.4 to -7.6 | <0.0001 |
IPSS Quality of life | 80 | 4.55 (1.27) | 2.54 (1.82) | -1.96 (1.86) | -2.3 to -1.4 | <0.0001 |
Qmax (ml/s) | 65 | 8.63 (2.71) | 13.55 (6.40) | 5.01 (6.39) | 3.4 to 6.6 | <0.0001 |
PVR (ml) | 65 | 60.78 (56.35) | 59.44 (56.43) | -2.20 (56.59) | (-16.7 to 12.3) | 0.7407 |
SHIM score | 80 | 13.40 (7.26) | 13.70 (7.76) | 0.40 (7.20) | (-1.2 to 2.0) | 0.7078 |
IIEF score | 80 | 39.28 (19.91) | 43.52 (22.24) | 3.83 (19.61) | (-0.7 to 8.3) | 0.0523 |
Outcome | n (paired) | baseline | follow up | change | 95% CI | p value |
|---|---|---|---|---|---|---|
IPSS Urinary Symptoms Score | 78 | 21.64 (6.80) | 12.69 (6.35) | -9.25 (6.49) | -11.0 to -7.4 | <0.0001 |
IPSS Quality of life | 78 | 4.51 (1.24) | 2.45 (1.79) | -1.90 (1.74) | (-2.2 to -1.4) | <0.0001 |
Qmax (ml/s) | 55 | 8.42 (2.09) | 11.93 (4.89) | 3.52 (5.24) | (2.0 to 5.0) | <0.0001 |
PVR (ml) | 55 | 57.62 (56.16) | 58.67 (72.36) | -0.16 (87.01) | (-24.6 to 24.3) | 0.9039 |
SHIM score | 78 | 14.03 (7.41) | 14.25 (7.45) | 0.45 (5.95) | (-1.0 to 1.9) | 0.3155 |
IIEF score | 77 | 40.01 (19.76) | 43.75 (19.85) | 4.51 (18.10) | (0.2 to 8.8) | 0.0101 |
Key safety findings
Implant group | control group | |||
|---|---|---|---|---|
Event | n | % | n | % |
Serious adverse events | 10 (16 events) | 7.8 | 2 (2 events) | 3.5 |
Procedure related serious events | 3 (5 events) | 2.3 | 0 | 0 |
All adverse events | 45 (109 events) | 38.1 | 10 (19 events) | 17.5 |
All procedure related adverse events | 39 (81 events) | 33.1 | 4 (4 events) | 7.0 |
Dysuria | 27 | 22.9 | 5 | 8.8 |
Haematuria | 16 | 13.6 | - | - |
Micturition urgency | 6 | 5.1 | 1 | 1.8 |
Pollakiuria (urinary frequency syndrome) | 8 | 6.8 | 1 | 1.8 |
Urinary retention | 7 | 5.9 | - | - |
Urinary tract infection | 2 | 1.7 | - | - |
Sepsis | 1 | 0.8 | - | - |
Pain | 1 | 0.8 | - | - |
Between 1 and 3 months after implant insertion, 1 patient had urinary retention and 1 had urinary tract infection. Between 3 and 12 months after implant insertion, 1 patient had urinary tract infection.
Study 2 Amparore D (2021)
Study type | Single-arm trial (MT-02) |
|---|---|
Country | Italy, Switzerland, Belgium, UK, Spain, Hong Kong (9 sites) |
Recruitment period | 2014 to 2016 |
Study population and number | n=81 Men with LUTS secondary to benign prostatic obstruction |
Age | Mean 63.9 years |
Patient selection criteria | Inclusion criteria: men with an IPSS 10 or above, prostate volume less than 75 ml, a maximum urinary flow rate less than 12 ml/s, a measured PVR less than 250 ml, normal urinalysis, complete blood count and biochemistry values. Exclusion criteria: patients with obstructive median lobe, previous prostate surgery, prostate or bladder cancer, neurogenic bladder or sphincter abnormalities, or confounding bladder pathologies based on medical history, recent cystolithiasis or haematuria, active urinary tract infection, compromised renal function, active antithrombotic or antiplatelet treatment, cardiac disease, including arrhythmias and uncontrolled diabetes mellitus. |
Technique | Device: second generation iTIND (Medi-Tate Ltd, Israel) Patients were required to have a washout and discontinue the use of any medications for LUTS secondary to BPH before treatment, 1 month for alpha-blockers and 6 months for 5α-Reductase inhibitors. Devices were retrieved at a mean (SD) of 5.7 (0.9) days after implantation. |
Follow up | 3 years |
Conflict of interest/source of funding | Not reported |
Analysis
Follow up issues: Data were available for 50 (62%) patients at 3-year follow up. Of the 81 enrolled patients, 7 were excluded from the final analysis because they had a TURP or holmium laser enucleation of the prostate, 5 were excluded because they needed drug therapy, 9 were excluded because the study site closed, 9 patients withdrew consent and 1 patient died (unrelated).
Study design issues: Prospective, single-arm, multicentre study. Feasibility and safety of the procedure and functional, sexual, and ejaculatory function were assessed up to 36 months. Treatment failure was defined as any surgical treatment for recurrent or persistent LUTS during follow-up. Analysis was done on an intention-to-treat basis, with imputation of missing values using last observation carried forward, and per-protocol with no imputation.
Study population issues: The median prostate volume at baseline was 40 ml (IQR 16 to 69 ml). Of the 81 patients, 10 (12%) had a median lobe, which was identified as a predictor of treatment failure.
Key efficacy findings
Number of patients analysed: 81
4 weeks | 6 months | 12 months | 24 months | 36 months | |
|---|---|---|---|---|---|
IPSS | |||||
Baseline | 22.34 (5.73) | 22.34 (5.73) | 22.34 (5.73) | 22.34 (5.73) | 22.34 (5.73) |
Follow up | 13.12 (8.68) | 11.29 (7.82) | 11.17 (7.79) | 12.21 (7.61) | 12.05 (8.13) |
Change | -9.22 (8.53) | -11.05 (7.48) | -11.17 (7.71) | -10.13 (7.37) | -10.29 (7.79) |
% change | -41.2 (34.5) | -50.0 (31.1) | -49.9 (31.4) | -45.3 (30.8) | -46.1 (34.4) |
95% CI | ‑48.8%, ‑33.6% | ‑56.8%, ‑43.1% | ‑56.8%, ‑43.1% | ‑52.1%, ‑38.6% | ‑53.7%, ‑38.6% |
p value | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 |
Quality of life | |||||
4.00 (0.85) | 4.00 (0.85) | 4.00 (0.85) | 4.00 (0.85) | 4.00 (0.85) | |
Follow up | 2.32 (1.45) | 2.07 (1.39) | 1.94 (1.42) | 2.23 (1.43) | 2.22 (1.44) |
Change | -1.68 (1.54) | -1.93 (1.49) | -2.06 (1.62) | -1.77 (1.56) | -1.78 (1.50) |
% change | -40.8 (35.5) | -47.2 (34.1) | -49.2 (38.9) | -42.2 (39.6) | -43.3 (39.1) |
95% CI | -48.6%, -33.0% | -54.6%, -39.7% | -57.7%, -40.6% | -50.9%, -33.5% | -51.9%, -34.7% |
p value | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 |
Qmax (ml/s) | |||||
7.28 (2.55) | 7.28 (2.55) | 7.28 (2.55) | 7.28 (2.55) | 7.28 (2.55) | |
Follow up | 11.91 (10.72) | 12.56 (6.47) | 13.25 (7.97) | 14.10 (8.96) | 13.43 (8.41) |
Change | 4.63 (10.49) | 5.28 (6.18) | 5.97 (7.88) | 6.82 (9.10) | 6.15 (8.40) |
% change | 73.8 (163.9) | 84.3 (104.3) | 96.3 (142.3) | 112.7 (163.1) | 101.1 (150.3) |
95% CI | 37.6%, 110.1% | 61.3%, 107.4% | 64.8%, 127.8% | 76.6%, 148.8% | 67.9%, 134.4% |
p value | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 |
PVR (ml) | |||||
Baseline | 78.72 (56.39) | 78.72 (56.39) | 78.72 (56.39) | 78.72 (56.39) | 78.72 (56.39) |
Follow up | 57.27 (68.78) | 57.17 (59.80) | 51.02 (69.24) | 45.85 (70.79) | 42.60 (71.08) |
Change | -21.44 (61.20) | -21.54 (64.26) | -27.69 (68.91) | -32.86 (68.14) | -36.11 (69.61) |
% change | -24.2 (60.9) | -8.6 (103.4) | -29.0 (91.1) | -43.0 (85.8) | -49.0 (84.5) |
95% CI | -38.2%, -10.2% | -32.4%, 15.1% | -50.0%, -8.0% | -62.8%, -23.3% | -68.4%, -29.5% |
p value | 0.0008 | 0.0005 | <0.0001 | <0.0001 | <0.0001 |
Outcome measure | 4 weeks n=78 | 6 months n=70 | 12 months n=67 | 24 months n=51 | 36 months n=50 |
|---|---|---|---|---|---|
IPSS | |||||
Baseline | 22.22 (5.62) | 21.99 (5.48) | 21.70 (5.56) | 20.51 (4.58) | 20.69 (4.58) |
Follow up | 11.72 (7.99) | 9.75 (7.10) | 8.78 6.41 | 8.51 (5.51) | 8.55 (6.38) |
Change | -10.50 (8.32) | -12.23 (6.79) | -12.92 (6.92) | -12.00 (6.12) | -12.14 (6.95) |
% change | -46.3 (33.2) | -56.4 (27.5) | -59.1 (26.3) | -56.7 (25.6) | -58.2 (32.1) |
95% CI | -54.0%, ‑38.5% | -63.0%, ‑49.8% | ‑65.7%, ‑52.5% | ‑64.1%, ‑49.4% | ‑67.4%, ‑49.0% |
p value | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 |
Quality of life | |||||
Baseline | 4.00 (0.84) | 3.97 (0.84) | 3.97 (0.87) | 3.96 (0.87) | 3.96 (0.87) |
Follow up | 2.08 (1.35) | 1.81 (1.30) | 1.59 (1.29) | 1.76 (1.32) | 1.76 (1.32) |
Change | -1.92 (1.50) | -2.16 (1.44) | -2.38 (1.60) | -2.20 (1.46) | -2.20 (1.46) |
% change | -45.8 (34.4) | -53.3 (32.5) | -56.9 (38.5) | -54.0 (38.5) | -55.6 (37.0) |
95% CI | -53.8%, -37.8% | -61.1%, -45.5% | -66.5%, -47.3% | ‑64.8%, ‑43.2% | -66.2%, -45.0% |
p value | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 |
Qmax (ml/s) | |||||
Baseline | 7.28 (2.49) | 7.58 (2.43) | 7.61 (2.25) | 7.62 (2.25) | 7.71 (2.26) |
Follow up | 11.23 (5.66) | 13.69 (6.26) | 14.91 (8.06) | 16.00 (7.43) | 15.20 (6.59) |
Change | 3.94 (5.22) | 6.12 (6.22) | 7.30 (8.20) | 8.38 (7.93) | 7.49 (6.86) |
% change | 79.4 (167.7) | 95.6 (106.5) | 111.7 (147.1) | 130.8 (132.2) | 114.7 (108.5) |
95% CI | 41.1%, 117.7% | 70.1%, 121.2% | 74.3%, 149.0% | 93.3%, 168.4% | 83.2%, 146.2% |
p value | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 |
PVR (ml) | |||||
Baseline | 76.17 (55.52) | 78.70 (56.11) | 73.54 (49.54) | 65.84 (38.46) | 68.58 (39.53) |
Follow up | 49.84 (57.27) | 48.84 (47.59) | 34.03 (54.13) | 14.26 (24.05) | 9.38 (17.43) |
Change | -26.33 (57.59) | -29.86 (60.89) | -39.51 (57.46) | -51.58 (36.68) | -59.21 (37.75) |
% change | -26.9 (60.5) | -13.8 (105.9) | -47.8 (72.5) | -75.7 (45.1) | -85.4 (30.7) |
95% CI | -41.3%, -12.6% | -39.9%, 12.2% | -66.7%, -28.9% | -88.9%, -62.4% | -94.6%, -76.3% |
p value | 0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 |
Key safety findings
There were no intraoperative complications. All perioperative complications were self-resolving and graded as Clavien-Dindo 1 or 2.
The median VAS pain score for the procedure was 4 (range 0 to 10). The mean VAS pain score after device removal was 2 (range 0 to 10).
Treatment-related adverse events within 1 month of procedure
Clavien-Dindo grade 1
Haematuria=12.3% (10/81)
Dysuria=7.4% (6/81)
Urgency=11.1% (9/81)
Pain=9.9% (8/81)
Clavien-Dindo grade 2
Urinary tract infection=6.2% (5/81)
Clavien-Dindo grade 3a
Urinary retention=9.9% (8/81); 5 while the device was in place and 3 after removal
Clavien-Dindo grade 3b
Secondary treatment (TURP, laser) = 2.5% (2/81)
Treatment-related adverse events 1 to 12 months after procedure
Clavien-Dindo grade 3b
Secondary treatment (TURP, laser) = 6.2% (5/81)
No adverse events were recorded between 12 and 36 months after the procedure.
None of the patients who were previously sexually active reported a deterioration in sexual or ejaculatory
abilities according to the yes/no questions during follow-up.
Study 3 De Nunzio C (2020)
Study type | Single-arm trial (MT-06) |
|---|---|
Country | Italy and Spain (5 centres) |
Recruitment period | 2018 to 2019 |
Study population and number | n=70 Men with LUTS secondary to benign prostatic obstruction |
Age | Mean 62.3 years |
Patient selection criteria | Inclusion criteria: IPSS 10 or above, Qmax less than 12 ml/s, prostate volume less than 120 ml; normal urinalysis and urine culture. Exclusion criteria included: previous prostate surgery, prostate cancer, urethral stricture, bladder stones, urinary tract infections, obstructing median lobe, neurological conditions potentially affecting voiding function. |
Technique | Device: iTind (Medi-Tate Ltd, Israel) Patients were not washed out of drug therapy for BPH (alpha-blockers or 5-alpha reductase inhibitors) and did not stop anti-coagulation or anti-platelet therapy before the procedure. Device retrieval was done under local anaesthesia 5 to 7 days after the procedure. All patients discontinued drug therapy for BPH after device retrieval. |
Follow up | 6 months |
Conflict of interest/source of funding | The study was sponsored by Medi-Tate. The authors declared that they had no conflict of interest. |
Analysis
Follow up issues: Follow up visits were done at 4 weeks, 3 and 6 months from device retrieval. No losses to follow up were reported.
Study design issues: Prospective, single-arm, multicentre study. The aim was to evaluate the functional outcomes regarding the preservation of urinary continence and sexual function.
Study population issues: The mean prostatic volume at baseline was 37.7 ml (IQR 15 to 80 ml).
Key efficacy findings
Number of patients analysed: 70
All procedures were completed successfully.
At 6 months, erectile and ejaculatory function and urinary continence were preserved in all 70 patients.
Outcome measure | 4 weeks, n=70 | 3 months, n=70 | 6 months, n=70 |
|---|---|---|---|
IPSS Urinary symptoms | |||
Baseline | 21.2 (6.0) | 21.2 (6.0) | 21.2 (6.0) |
Follow up | 9.5 (6.8) | 7.8 (5.4) | 8.3 (6.7) |
Change | -11.7 (8.3) | -13.4 (6.4) | -12.7 (6.9) |
p value | <0.01 | <0.01 | <0.01 |
IPSS Quality of life | |||
Baseline | 4.1 (1.0) | 4.1 (1.0) | 4.1 (1.0) |
Follow up | 1.8 (1.4) | 1.6 (1.3) | 2.0 (1.4) |
Change | -2.4 (1.5) | -2.5 (1.6) | -2.2 (1.6) |
p value | <0.01 | <0.01 | <0.01 |
Peak flow rate (ml/s) | |||
Baseline | 7.3 (2.2) | 7.3 (2.2) | 7.3 (2.2) |
Follow up | 13.2 (5.5) | 11.8 (5.1) | 12.0 (5.4) |
Change | 5.8 (5.5) | 4.5 (5.2) | 4.6 (5.5) |
p value | <0.01 | <0.01 | <0.01 |
PVR (ml) | |||
Baseline | 69.3 (86.8) | 69.3 (86.8) | 69.3 (86.8) |
Follow up | 49.2 (74.5) | 33.4 (46.2) | 48.1 (72.7) |
Change | -19.4 (95.4) | -37.4 (90.5) | -22.6 (77.3) |
p value | 0.13 | 0.11 | 0.12 |
SHIM total score | |||
Baseline | 16.1 (7.7) | 16.1 (7.7) | 16.1 (7.7) |
Follow up | 18.0 (7.6) | 18.7 (7.7) | 18.2 (8.2) |
Change | 1.9 (4.8) | 2.3 (6.9) | 2.2 (7.4) |
p value | 0.09 | 0.07 | 0.06 |
Incontinence Symptom Index questionnaire total score | |||
Baseline | 1.1 (1.9) | 1.1 (1.9) | 1.1 (1.9) |
Follow up | 0.6 (1.4) | 0.9 (1.7) | 0.8 (1.6) |
Change | -0.5 (1.7) | -0.3 (1.5) | -0.3 (1.4) |
p value | 0.21 | 0.14 | 0.14 |
Male Sexual Health Questionnaire – ejaculatory function score (higher scores indicate better function) | |||
Baseline | 9.2 (4.9) | 9.2 (4.9) | 9.2 (4.9) |
Follow up | 10.7 (4.6) | 11.1 (4.9) | 11.2 (4.8) |
Change | 1.5 (5.1) | 1.8 (5.2) | 2.0 (4.4) |
p value | <0.01 | <0.01 | <0.01 |
Key safety findings
There were no intraoperative complications.
The mean VAS pain score was 3.2 after the implantation procedure and showed a gradual decrease to 1.5 by day 7. The mean VAS pain score after the removal procedure was 3.4.
Reported complications
Total number of complications=75
Clavien-Dindo grade 1
Transient haematuria=18.6% (13/70)
Dysuria=17.1% (12/70)
Urgency=12.8% (9/70)
Frequency=7.1% (5/70)
Pain=11.4% (8/70)
Transient urinary incontinence (device in situ) = 8.4% (6/70)
Clavien-Dindo grade 3a
Acute urinary retention=4.2% (3/70); 2 were in patients with the device in situ and 1 was 12 hours after device removal. All 3 had treatment with temporary catheterisation.
Clavien-Dindo grade 3b
Gross haematuria=1.4% (1/70); treated by endoscopic fulguration.
Study 4 Porpiglia F (2018) – included in 2018 overview
Study type | Single-arm trial |
|---|---|
Country | Italy |
Recruitment period | 2010 to 2013 |
Study population and number | n=32 Patients with BPH-related LUTS |
Age | Mean 69.4 years |
Patient selection criteria | Inclusion criteria included: age over 50 years, IPSS 10 or above, peak urinary flow (Qmax) 12 ml/s or less, and prostate volume (as assessed by transrectal ultrasound) less than 60 ml. Patients were excluded if they had history of prostate surgery, prostate cancer, urethral stricture, bladder stones, obstructive median lobe, and history of significant medical comorbidities, haemostatic disorders or suspected neurological conditions that could underlie impaired voiding function. |
Technique | Device: first generation temporary implantable nitinol device (TIND; Medi-Tate Ltd., Israel) The device was retrieved 5 days after insertion, using rigid urethroscopy in an outpatient setting. |
Follow up | 36 months |
Conflict of interest/source of funding | None |
Analysis
Follow-up issues: Patients visited an outpatient setting at 5 days (removal day), 3 and 6 weeks, and 3, 6, 12, 24 and 36 months after the implantation, for assessment of uroflowmetry, IPSS, and IPSS quality of life score. Of the 32 patients, 1 died from a cause unrelated to the procedure, at 26 months after device implantation.
Study design issues: Single-arm, prospective, single-centre trial. The aim was to assess perioperative results, complications (according to Clavien–Dindo classification), functional results, and quality of life. Sexual dysfunction in sexually active patients was investigated by asking the patient: 'after the intervention, did you record any changes in terms of ejaculation?'. Patient satisfaction with the procedure was assessed using Question 32 of the Expanded Prostate Cancer Index Composite questionnaire to the patients during the follow-up visits: 'Overall, how satisfied are you with treatment you received for your prostate disease intervention?', with a choice of 5 possible responses (1 extremely dissatisfied, 2 dissatisfied, 3 uncertain, 4 satisfied, 5 extremely satisfied). Treatment failure during follow-up was defined as the need for any surgical treatment for LUTS related to BPH.
Study population issues: All patients were on alpha blocker therapy at the time of the procedure, with 46% regularly using 5-alpha-reductase inhibitors. The mean prostate volume at baseline was 29.5 mL (SD 7.4).
Key efficacy findings
Number of patients analysed: 32
IPSS - mean percentage changes (SD) compared with baseline
3 weeks= -39 (0.3)
6 weeks= -50 (0.3)
3 months= -55 (0.2)
6 months= -47 (0.2)
12 months= -45 (0.3)
24 months= -23 (0.5)
36 months= -19 (0.5)
Peak urinary flow - mean percentage changes (SD) compared with baseline
3 weeks= 37 (1)
6 weeks= 72 (0.6)
3 months= 61 (0.7)
6 months= 61 (0.8)
12 months= 67 (0.8)
24 months= 54 (0.6)
36 months= 41 (1)
There was a statistically significant increase in peak urinary flow values over the first 12 months after treatment, peaking at a mean 72% increase by 6 weeks after treatment and remaining steady over the ensuing 12 months (p<0.001).
There was also a statistically significant difference between baseline values and the postoperative IPSS and quality of life scores (p<0.001). The median quality of life score was 2 at 24 and 36 months after treatment, compared with 3 at baseline.
Medication
All patients were able to discontinue LUTS-related medical therapy 3 months after the implantation, but 3 patients (9%) needed it again within 12 or 24 months of treatment.
Multiple regression analysis did not identify any independent prognostic factors predictive of the need for BPH-related medical therapy after the procedure, increase of peak urinary flow or decrease of IPSS.
Overall, no patients needed any surgical therapy for BPH during follow up. None of the 19 patients reporting preoperative sexual activity reported any ejaculatory dysfunction during follow up.
Patient satisfaction
The median Expanded Prostate Cancer Index Composite question 32 score was 5 (corresponding to extremely satisfied) throughout follow up and the differences at different time points were not statistically significant (p=0.180).
Key safety findings
There were no intraoperative complications.
The median VAS pain score 6 hours after the procedure was 2 (IQR 2 to 4).
Complications within 30 days of procedure
Total=12.5% (4/32)
Urinary incontinence because of device displacement, n=1 (resolved after device was removed on day 1)
Urinary retention on the same day as device implantation, n=1
Genitourinary infection=6.3% (2/32) (treated with antibiotics)
There were no further complications reported during follow up.
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