Interventional procedure overview of image-guided transperineal laser ablation (TPLA) for treating lower urinary tract symptoms caused by benign prostatic hyperplasia
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Evidence summary
Population and studies description
This interventional procedures overview is based on 660 people from 2 RCTs, 2 systematic reviews (1 of which also includes the RCT), 4 prospective case series and 1 retrospective case series. Of these 660 people, 590 people had TPLA, 50 had TURP and 20 had PAE. This is a rapid review of the literature, and a flow chart of the complete selection process is shown in figure 1. This overview presents 9 studies as the key evidence in table 2 and table 3, and lists 15 other relevant studies in appendix B, table 5. There is an overlap of people between 3 studies (Bertolo 2023, Tafuri 2023 and Tzelves 2023). The RCT by Bertolo (2023) is also included in 1 systematic review (Tzelves 2023).
One RCT evaluated ejaculatory function in people with BPH after TPLA or TURP on a 1:1 ratio, but the sample size was small and was based on ejaculatory function outcomes. People were not blinded to interventions and 4 people in the TURP group refused treatment. A high proportion of people (88%) had medical therapy before the interventions and had no wash-out before surgery, so the baseline ejaculatory function scores could have been modified (Bertolo 2023). The study by Canat (2023) was described as a prospective, randomised controlled single-centre study, comparing TPLA with TURP. Randomisation was done by dividing people 1:1 according to order of admission. The study included people who were candidates for TURP.
A systematic review and meta-analysis included 6 small studies of low or intermediate quality (according to the Ottawa-Newcastle scoring system). Risk of bias was assessed using Cochrane tools for non-randomised studies. A pooled analysis was done, and high heterogeneity between studies was noted (Tafuri 2023).
Another systematic review included 11 studies of low or intermediate quality (except for 1 single centre RCT [Bertolo 2023]). Risk of bias was also assessed using Cochrane tools for randomised and non-randomised studies. No meta-analysis was done because of the lack of comparative studies using the same groups. There is an overlap of 6 studies between the systematic reviews (Tzelves, 2023).
The 4 prospective studies assessed the efficacy and safety of TPLA (van Kollenburg R 2024, Destefanis 2023, Polverino 2024 and Bianco 2024). The small pilot study (Kollenburg 2024) assessed the feasibility of TPLA in healthy people suitable for standard surgery. The single-centre study (Polverino 2023) assessed functional and safety outcomes in people for whom standard surgery was not an option.
One retrospective single centre case series of 20 people reported outcomes at 3‑year follow up (Minafra 2023) and one prospective study of 20 people reported outcomes at 2‑year follow up (Bianco 2024).
Table 2 presents study details.
Study no. | First author, date country | Characteristics of people in the study (as reported by the study) | Study design | Inclusion criteria | Intervention | Follow up |
|---|---|---|---|---|---|---|
1 | Bertolo 2023 Italy | 51 people with BPH (26 TPLA versus 25 TURP) Mean age: TPLA 63.0; TURP 68.5 years. | RCT (single centre) (NCT04781049) | People with BPH between 18 and 75 years, with normal ejaculatory function (assessed by EJ-MSHQ), presence of antegrade ejaculation before surgery (or before medical therapy, or both), IPSS more than10; Qmax less than 15 ml/s, PV more than 100 ml, and normal urine analysis. | TPLA (using the EchoLaser) versus TURP (standard treatment using a bipolar energy resectoscope), both groups had spinal anaesthesia. | 6 months |
2 | Tafuri 2023 Italy | 297 people with BPH Mean (years): Pacella 2019: 69.8 Cai 2021: 73.9 Manenti 2021: 72.1 Median (years): De Rienzo 2021: 62 Frego 2021: 61.9 Sessa 2022: 72 | Systematic review and meta-analysis 6 studies (2 retrospective and 4 prospective studies). | English articles published between 2000 and 2022 focused on TPLA for BPH, with more than 20 people, and reporting outcomes of interest. In all studies, severity of LUTS and QoL assessed using the IPSS (cut off score of 12 in 4 studies and 8 in 1 study). People with prostate volume of more than 30 ml, Qmax 15 ml/s or less and a PVR between 50 and 400 ml were included; those unresponsive to previous medical therapy in 2 studies, with PSA value less than 4 ng/ml/negative biopsy/negative DRE in 1 study were included. | TPLA using EchoLaserTM (SoracteLiteTM) | Varied across studies, up to 12 months. |
3 | Tzelves 2023 Europe | 477 (432 had TPLA, 20 had PAE and 25 had TURP) Age: ranged between 61.9 and 73.9 years. | Systematic review (11 studies) 1 RCT, 9 observational studies and 1 animal study. (2 of these comparative – TPLA versus TURP TPLA versus PAE) | Studies published from 2000 to 2023, observational studies (prospective or retrospective), single arm or comparative, and RCTs, reporting clinical outcomes were included. inclusion criteria of studies included: people over 18 years old and PV between 30 and 100ml (based on TRUS or MRI measurements) as well as LUTS with IPSS 12 or more, Qmax 15ml/s or less, or PVR 50 to 400ml. | TPLA (from the 11 studies 2 were comparative,1 with prostatic artery embolisation and 1 with TURP) | 12 months |
4 | Minafra 2023 Italy | 20 people affected by BPH related symptoms. Median age 63 years. | Retrospective case series (single centre) | People with symptomatic benign prostatic obstruction: IPSS 12 points or higher, Qmax 15 ml per second or less, and transrectal ultrasound prostate volume between 30 ml and 100 ml. | TPLA using the SoracteLite™ EchoLaser X4 system Local anaesthesia with sedation | 3 years |
5 | Canat 2023 Turkey | 50 people (TPLA, 25; TURP, 25) Mean age (SD): TPLA 65.58 (6.59); TURP 64.20 (6.21) | Prospective RCT (single centre) Randomisation was done by dividing people into 1:1 groups according to the order of admission | Patients with IPSS above 12, maximum urine flow rate (Qmax) 15 ml/s or less, and age 50 or above | TPLA and TURP TPLA was done under local anaesthesia with sedation, TURP was done under spinal anaesthesia | 12 months |
6 | Destefanis 2023 Italy | 40 people Median age (IQR): 80 (72.5 to 84) | Prospective case series | High-risk (high haemorrhagic risk, due to ongoing pharmacological therapy and preexisting diseases), adult, Caucasian people, seeking surgical treatment for BPH or LUTS with ASA score more than 3 affected by a moderate to severe or complicated BPH condition | TPLA (with SoracteLite™ Echolaser® X4 system) Local anaesthesia with or without light sedation | 6 months |
7 | van Kollenburg R 2024 The Netherlands | 20 people Mean age 70.3 years | Prospective case series (multicentre pilot study; NCT03653117) | People 40 years or older, had urodynamically proven bladder outlet obstruction, a Qmax of 5 to 15 ml/s, a prostate volume of 30 to 120 cc, spontaneous voiding, and were fit for standard transurethral surgery. | TPLA (with SoracteLite™ Echolaser® X4 system) using local anaesthesia and optional sedation. (16 in an outpatient setting, 4 in the operating room, of these 2 under general anaesthesia). | 12 months |
8 | Polverino 2023 Italy | 23 people Median age (IQR): 77 (68 to 84) | Prospective case series | People with moderate to severe LUTS for whom standard surgery was not an option, prostate volume ranging from 30 to 100 ml, and an ASA Score 3 or above | TPLA using EchoLaser™ (Elesta SpA, Calenzano, Florence, Italy) multisource diode laser generator Local anaesthesia with or without sedation | Median follow-up: 12 months |
9 | Bianco 2024 | 20 people Mean age: 66 years | Prospective case series | People with benign prostatic hyperplasia with LUTS measured by an IPSS above 9, serum creatinine levels below 1.5 ng/dl and glomerular filtration rate above 55. | TPLA using EchoLaser X4 system (Elesta SpA, Calenzano, Italy) Local anaesthesia | 24 months |
Procedure technique
All studies detailed the procedure technique and device used. TPLA was done using the SoracteLite EchoLaser, Elesta laser ablation system. A dedicated smart planning tool (Echolaser Smart Interface) was used to plan the treatment and to place laser optical fibres in the prostate in a safe manner. The procedure was done as a day-case procedure, mostly under local anaesthesia with or without sedation in a few small pilot studies. People could be discharged in 6 hours after the procedure. Additional fibres were used depending on the size of the prostrate. Ultrasound guidance was used mainly across studies, but one study used MRI. Low power laser light energy between 3 to 5 watts was used across studies.
Efficacy
Preservation of sexual function
Ejaculatory function (assessed by the MSHQ-EjD)
Five included studies reported this outcome.
A RCT of 51 people comparing TPLA (n=26) with TURP (n=25) reported that the distribution of ejaculatory function (assessed by the MSHQ-EjD) at 1 month remained unchanged from baseline in the TPLA group (29 to 29, p=0.2), but decreased significantly from baseline in the TURP group (29 to 20, p=0.01; Bertolo 2023).
A RCT of 50 people, 25 of whom had TPLA showed that there was no change in first year of the MSHQ 1, 2, 3, and MSHQ 4 scores compared with the baseline values in the TPLA group (p=0.54 for MSHQ 1,2,3 and p=0.34 for MSHQ 4; Canat 2023).
In a systematic review of 297 people assessing TPLA in people with BPH, ejaculatory function reported in 3 studies (n=95) improved from baseline at 1 and 3 months follow up. The overall pooled mean for MSHQ-EjD score improved from baseline score of 5.08 (based on 3 studies, n=95), to 7.34 at 1 month and 7.95 at 3 months (based on 2 studies, n=51; Tafuri, 2023).
In the systematic review of 477 people assessing TPLA, more than 95% of people retained their ejaculation function (Tzelves 2023).
The retrospective case series of 21 people who had TPLA showed that the median ejaculatory function, assessed by the MSHQ-EjD questionnaire statistically significantly improved from 4 at baseline to 11 at 3 years follow up (improved by 60%, p<0.01; Minafra 2023).
Preserved antegrade ejaculation
Three studies reported this outcome.
In the RCT of 51 people comparing TPLA with TURP, presence of antegrade ejaculation (defined as 'emission of semen after orgasm') was statistically significantly higher in people in the TPLA group (96%, 25/26) compared with those in the TURP group (28%, 7/25) at 1 month follow up (p<0.001; Bertolo 2023).
In a prospective case series of 20 people who had TPLA, there was no significant change in the number of people reporting antegrade ejaculation at 6, 12 and 24 months (84%; 90%, 90% [17/19]) compared with baseline (p=0.1 at 24 months; Bianco 2024).
The small pilot study of 20 people who had TPLA in an outpatient setting under local anaesthesia reported that IIEF-15 total score remained stable, and 85% (11/13) of people preserved antegrade ejaculation and 15% (2/13) had retrograde ejaculation (van Kollenburg 2024).
Erectile function (assessed by IIEF-5)
Five studies reported this outcome.
The RCT of 51 people with BPH comparing TPLA (n=26) with TURP (n=25) reported no statistically significant difference in median IIEF-5 scores at 1 month follow up compared with baseline (TPLA group: from 17 at baseline to 18 at 1 month, p=0.5; TURP group: from 20 at baseline to 19 at 1 month, p=0.3). No statistically significant differences were found between the groups (p=0.3) at 1 month follow up (Bertolo 2023).
The RCT of 50 people showed similar IIEF-5 scores between TPLA and TURP groups (p=0.83 and p=0.12, respectively) at 1‑year follow up (Canat 2023).
In the systematic review of 297 people with BPH assessing TPLA, the overall pooled mean value for IIEF-5 score (based on 3 studies, n=95) at baseline was 18.35 and remained unchanged at 1 month (17.98) and at 3 months (20.54; Tafuri, 2023).
In the systematic review of 477 people assessing TPLA, sexual function was evaluated after surgery. Most studies reported erectile function was maintained or improved (Tzelves 2023).
A retrospective case series of 21 people who had TPLA showed no statistically significant change in median IIEF-5 score from baseline (17) to 3 years (17; Minafra 2023).
Symptom relief (assessed by IPSS)
All 9 studies reported this outcome.
The RCT of 51 people with BPH comparing TPLA (n=26) with TURP (n=25) reported that both treatments improved median IPSS scores significantly at 6 months follow up compared with baseline (TPLA group: from 24 at baseline to 11 at 6 months, p=0.01; TURP group: from 20 at baseline to 8 at 6 months, p<0.001). No statistically significant differences in IPSS score were found between the groups (p=0.1) at 6 months (Bertolo 2023).
The RCT of 50 people showed statistically significant improvement in IPSS score compared with baseline values in both TPLA and TURP groups at 1 year (p<0.01; Canat 2023).
In the systematic review of 297 people with BPH assessing TPLA, the overall pooled mean for IPSS (based on 6 studies, n=297) improved statistically significantly from baseline (20.96) to 3 months (9.80), and then remained stable at 6 months (6.92), and 12 months (6.40) follow up (p<0.01 for 3 and 6 months, p=0.03 at 12 months; Tafuri, 2023).
In the systematic review of 477 people assessing TPLA, the baseline median IPSS score (range 18.3 to 22.7) reduced at 3 months (range 8 to 13.1) and 6 to 12 months (range 5 to 7) follow up. The QOL component of IPSS was also improved from baseline (Tzelves 2023).
A retrospective case series of 21 people who had TPLA showed statistically significant improvement in IPSS at 3 years follow up. Median IPSS values changed from 18 at baseline to 12 at 3 years, with a median score reduction of 6 points (score decreased by 37%, p<0.01; Minafra 2023).
A pilot study of 20 people who had TPLA in an outpatient setting under local anaesthesia reported that IPSS significantly improved from 21.3 at baseline to 10.9 at 12 months follow up (p<0.0001; van Kollenburg 2024).
A prospective case series of 40 people who had TPLA showed statistically significant improvement in IPSS at 6 months after surgery compared with baseline median values (8 [6 to 11.5], −17 points, −68%, p=0.001). There was also a significant improvement between the 3-month and the 6-month assessments (p=0.037; Destefanis 2023).
In a preliminary single-centre experience study of 21 people who had TPLA for BPH, 57% (12/21) people reported an improvement in IPSS symptoms, with 8 of these having an improvement from severe to moderate, 3 from severe to mild and 1 from moderate to mild LUTS at median 12 months follow up. One patient experienced worsening of symptom status according to IPSS (Polverino 2023).
In the prospective case series of 20 people who had TPLA, the median IPSS score reduced significantly from baseline 14 (IQR 12 to 17) to 6 (IQR 3 to 8) at 6 months; 3 (IQR 5 to 2) at 12 months, and 3 (IQR 2 to 4) at 24 months (p<0.001 at all timepoints; Bianco 2024).
Urodynamic parameters
Maximum urinary flow rate (Qmax)
Eight studies reported this outcome.
The RCT of 51 people with BPH comparing TPLA (n=26) with TURP (n=25) reported that both treatments had a statistically significant mean improvement in Qmax at 6 months follow up compared with baseline (TPLA group: from baseline median value 10.2 to 15.2 at 6 months, p<0.001; TURP group: from baseline 10.0 to 26.0, p=0.006). A statistically significant difference was found between the treatment groups at 6 months (TPLA compared with TURP: 15.2 ml/s compared with 26.0 ml/s; p<0.001; Bertolo 2023).
The RCT of 50 people, 25 of whom had TPLA, showed statistically significant improvement in Qmax compared with baseline values in both TPLA and TURP groups at 1 year (p<0.01). In the first year the Qmax values of the groups were statistically significantly higher in the TURP group than in the TPLA group (p<0.01; Canat 2023).
In the systematic review of 297 people assessing TPLA in people with BPH, the overall pooled mean for Qmax (based on 6 studies, n=297) statistically significantly improved from baseline 8.69 ml/s to 13.17 ml/s at 3 months (p<0.01), 14.55 ml/s at 6 months (p=0.55), and 17.12 ml/s at 12 months (p<0.01; Tafuri, 2023).
In the systematic review of 477 people assessing TPLA, the median Qmax at baseline was 7.6 ml/s to 9.2 ml/s and increased to 11 ml/s to 13.3 ml/s at 3 months and 11.5 ml/s to 20.5 ml/s at 6 to 12 months. In 1 study comparing TPLA with PAE there was no significant difference in Qmax values at 3 and 6 months follow up between the groups (p=0.776; p=0.420; Tzelves 2023).
The small retrospective case series of 21 people who had TPLA showed significant improvement in Qmax at 3 years follow up. Median Qmax values changed from baseline 8.8 to 11.0 at 3 years with a median score improvement of 3.2 ml/s (46% increase, p<0.01; (Minafra 2023).
The small pilot study of 20 people who had TPLA in an outpatient setting under local anaesthesia reported that Qmax improved from baseline 9.7 to 14.9 at 12 months follow up (p=0.015; van Kollenburg 2024).
A small prospective case series of 40 people who had TPLA showed some improvement in Qmax score at 6 months after surgery compared with baseline median values (8 [IQR 5.5 to 10] to 12 [IQR 10 to 13], p=0.044) (Destefanis 2023).
In the prospective case series of 20 people who had TPLA, the mean Qmax score improved significantly from 9.5 at baseline to 16.9 at 6 months, 20.7 at 12 months and 22.3 at 24 months (p<0.001 at all timepoints; Bianco 2024).
PVR urine volume
Eight studies reported this outcome.
In the RCT of 51 people comparing TPLA with TURP, PVR decreased from baseline in both the groups at 6 months (TPLA from 70 at baseline to 0 at 6 months; TURP from baseline 30 to 0). No statistically significant differences were found between the groups for PVR urine volume (p=0.6) at 6 months follow up (Bertolo 2023).
The RCT of 50 people, 25 of whom had TPLA, showed statistically significant improvement in PVR compared with baseline values in both TPLA and TURP groups at 1 year (p<0.01; Canat 2023).
In the systematic review of 297 people assessing TPLA in people with BPH, the overall pooled mean value for PVR (based on 6 studies, n=297) statistically significantly improved from 91.94 ml at baseline to 36.06 ml at 3 months, 27.57 ml at 6 months, and 22.27 ml at 12 months (p<0.01 for all timepoints; Tafuri, 2023).
In the systematic review of 477 people assessing TPLA, the median PVR ranged between 60.0 and 199.9 ml among studies at baseline with median postoperative values ranging between 45.6 ml and 54.8 ml at 3 months and 41.5 ml and 60.3 ml at 6 to 12 months of follow up. In 1 study comparing TPLA and PAE there was no statistically significant difference in PVR urine volume at 3 and 6 months follow up between the groups (p=0.745 and p=0.607, respectively; Tzelves 2023).
The small retrospective case series of 21 people who had TPLA showed that the median PVR reduced from 70 ml at baseline to 15 ml at 3 years follow up (decreased by 86%, p<0.01; Minafra 2023).
The small pilot study of 20 people who had TPLA in an outpatient setting under local anaesthesia reported that PVR did not change significantly from 61.8 ml at baseline to 44.2 ml, p=0.755) at 12 months (van Kollenburg 2024).
A small prospective case series of 40 people who had TPLA showed that PVR did not change significantly from baseline to 6 months follow up (50 ml [15 to 180] to 30 ml [0 to 60], p=0.092). There was no change in PVR between 3 and 6 months (p=0.547; Destefanis 2023).
In the prospective case series of 20 people who had TPLA, the mean PVR volume ratio significantly reduced from baseline 24.6 to 9.7 at 6 months (p=0.001), 7.9 at 12 months (p<0.001) and 7.4 at 24 months (p<0.001; Bianco 2024).
PV
Four studies reported this outcome.
In the systematic review of 11 studies, 1 study comparing TPLA and PAE reported that there was no significant difference in PV at 3 and 6 months follow up between the groups (p=0.527 and p=0.573, respectively; Tzelves 2023).
The small retrospective case series of 21 people who had TPLA showed that the median TRUS PV reduced by 20.4% (IQR -25.3; -16.0 ml) from 41.5 ml at baseline to 35.0 ml (IQR 32.0 to 38.8) at 3 years follow up (p<0.01; Minafra 2023).
The small pilot study of 20 people who had TPLA in an outpatient setting under local anaesthesia reported that PV did not change significantly, from baseline 65.5 ml to 63.2 ml (p=0.251) at 12 months (van Kollenburg 2024).
A small prospective case series of 40 people who had TPLA reported that median PV significantly reduced from baseline 38 [IQR 30.5 to 73] to 35 [IQR 26 to 49], (p<0.001). There was no change in PV between 3 and 6 months (p=0.040; Destefanis 2023).
Quality of life
Nine studies reported this outcome.
The RCT of 51 people comparing TPLA with TURP reported that QoL scores significantly improved for both groups at 6 months from baseline (the median score in the TPLA group from 5 to 2 [p=0.002] and in the TURP group from 4 to 2 (p=0.001). No statistically significant differences were found between the groups at 6 months follow up (p=0.1; Bertolo 2023).
The RCT of 50 people, 25 of whom had TPLA, showed an improvement in first year of IPSS QoL compared with the baseline values in the TPLA group (p<0.01; Canat 2023).
In the systematic review of 297 people with BPH assessing TPLA, the overall pooled mean value for QoL score (based on 6 studies, n=297) statistically significantly improved from 4.52 at baseline to 1.47 at 3 months, 1.66 at 6 months, and 1.55 at 12 months (p<0.01 for all timepoints; Tafuri, 2023).
In the systematic review of 477 people assessing TPLA, the median QoL ranged between 5 and 5.8 (based on the IPSS QoL-related question) among studies at baseline with median postoperative values ranging between 1 and 2.1 at 3 months and 1 and 2.3 at 6 to 12 months of follow up. In 1 study comparing TPLA and PAE there was no significant difference in QoL at 3 and 6 months follow up between the groups (p=0.527 and p=0.294, respectively; Tzelves 2023).
The small retrospective case series of 21 people who had TPLA showed that the median QoL score significantly decreased from 4 at baseline to 2 at 3 years follow up (decreased by 60%, p<0.01; Minafra 2023).
The small pilot study of 20 people who had TPLA in an outpatient setting under local anaesthesia reported that QoL improved significantly from 4.9 at baseline to 1.9 (p<0.0001) at 12 months (van Kollenburg 2024).
A small prospective case series of 40 people who had TPLA showed statistically significant improvement in IPSS QoL score at 6 months after surgery compared with baseline median values (2 [0 to 4.9], −4 points, −66.6%, p<0.001). There was also a significant improvement between the 3-month and the 6-month assessments (p=0.028; Destefanis 2023).
In the preliminary single-centre experience study of 21 people who had TPLA for BPH, the median QoL score improved from a pre-operative score of 4 (IQR 3 to 5) to a postoperative score of 2 (IQR 1 to 3) at median 12 months follow up (Polverino 2023).
In the prospective case series of 20 people who had TPLA, the median IPSS-QoL score significantly reduced from baseline 5 (IQR 4 to 6) to 2 (IQR 2 to 3) at 6 months (p=0.005), 2 (IQR 1 to 3) at 12 months (p<0.001) and 1 (IQR 1 to 3) at 24 months (p<0.001; Bianco 2024).
Satisfaction with the treatment (EPIC, question 32 response)
In the RCT of 51 people, based on EPIC question 32, a statistically significantly smaller proportion of people were satisfied with treatment in the TPLA group compared with the TURP group (50% [13/26] compared with 80% [20/25], p=0.02; Bertolo 2023).
Procedure outcomes
In the RCT of 51 people, the median procedure time was statistically significantly shorter in the TPLA group compared with TURP group (35 minutes compared with 68 minutes; p<0.001). The median hospital stay was longer in those who had TURP compared with TPLA (3 days compared with 2 days; p=0.008). The median catheterisation time was not statistically different between the groups (4 days for TPLA compared with 3 days forTURP, p=0.7; Bertolo 2023).
In the systematic review of 6 studies on TPLA, procedure time ranged from 28.2 minutes to 60.9 minutes. Median length of hospital stay ranged from 6.4 hours to 1.8 days, and catheterisation time ranged from 7 days to 16.5 days (Tafuri 2023).
In the systematic review of 11 studies, procedure time ranged between 28 minutes and 61 minutes. Length of hospital stay ranged from 1 day to 2 days, and catheterisation time ranged between 4 days and 17.3 days (Tzelves 2023).
Safety
Pain
In the RCT of 51 people, there were no differences in the perception of pain (assessed by VAS) between the TPLA and TURP groups (median score 0 compared with 1, p=0.9; Bertolo 2023).
The small pilot study of 20 people who had TPLA in an outpatient setting under local anaesthesia reported that pain score (assessed on VAS) improved after TPLA but was not significantly different between baseline and 12 months follow up (0.9 to 0.1; p=0.313; van Kollenburg 2024).
In the prospective case series of 20 people who had TPLA, 15% (3/20) people had a mean pain score (VAS) of 1, 40% (8/20) people had a pain score of 2, 30% (6/20) people had a pain score of 3 and 15% (3/20) had a pain score of 4 (Bianco 2024).
Haematuria
In the systematic review of 297 people with BPH assessing TPLA, 1 study (Pacella 2019) reported that 3 people experienced transient haematuria and another study (Manenti 2021) reported that 1 person experienced prolonged haematuria. All were managed by keeping the bladder catheter in place for a few days (Tafuri, 2023).
The small pilot study of 20 people who had TPLA in an outpatient setting under local anaesthesia reported that HGS score improved after TPLA but this was not significantly different between baseline and 12 months follow up (0 to 0.2; p=0.50; van Kollenburg 2024).
The small prospective case series of 40 people who had TPLA reported haematuria in 1 person (Destefanis 2023).
Urinary retention
In the RCT of 51 people, those who had TPLA had a higher rate of acute urinary retention after catheter removal compared with those who had TURP (19% [5/26] versus 0% [0/25]; p=0.02; Bertolo 2023).
In the systematic review of 297 people assessing TPLA in people with BPH, acute urinary retention needing major antibiotic treatment was reported in 14% (3/22) of people in one study (Frego 2021) and 2% (3/160) of people in another study (Pacella 2019, Tafuri, 2023).
The small prospective case series of 40 people who had TPLA reported urinary retention in 33% (13/40) of people (Destefanis 2023).
The small pilot study of 20 people who had TPLA in an outpatient setting under local anaesthesia reported urinary retention in 50% (10/20) of people (van Kollenburg 2024).
Urinary tract infection
In the systematic review of 297 people with BPH assessing TPLA, 1 study (Frego 2021) reported that 9% (2/22) of people had urinary tract infection needing major antibiotic treatment (Tafuri 2023).
Orchitis
In the systematic review of 297 people assessing TPLA in people with BPH, 2 studies (Pacella 2019 and Manenti 2021) reported orchitis in 1 person in each study and both had antibiotic treatment (Tafuri, 2023).
In the systematic review of 477 people assessing TPLA, 1 study (Lagana 2022, n=63) reported orchitis in 1 person (1.6%; Tzelves 2023).
Prostatic abscess
In the systematic review of 297 people with BPH assessing TPLA, 3 studies (Pacella 2019, De Rienzo 2021 and Manenti 2021) reported prostatic abscess in 1 person in each study. All cases had treatment with percutaneous drainage and antibiotic therapy (Tafuri, 2023).
In the systematic review of 477 people assessing TPLA, 4 studies (Pacella 2019, De Rienzo 2021, Manenti 2021, Lagana 2022) reported prostatic abscess in 5 people (1% to 5% of each study population; Tzelves 2023).
Intraoperative urethral burn
In the systematic review of 297 people with BPH assessing TPLA, 1 study (Cai 2021, n=20) reported an intraoperative complication consisting of urethral burn. This was treated by keeping the bladder catheter for a few days (Tafuri, 2023).
Dysuria
In the systematic review of 297 people with BPH assessing TPLA, 1 study (Frego 2021) reported dysuria that resolved spontaneously in 36% (8/22) of people and another study (Pacella 2019) reported transient dysuria in 4% (6/160) of people (Tafuri 2023).
The small pilot study of 20 people who had TPLA in an outpatient setting under local anaesthesia reported dysuria in 25% (5/20) of people (van Kollenburg 2024).
Anecdotal and theoretical adverse events
Expert advice was sought from consultants who have been nominated or ratified by their professional society or royal college. They were asked if they knew of any other adverse events for this procedure that they had heard about (anecdotal), which were not reported in the literature. They were also asked if they thought there were other adverse events that might possibly occur, even if they had never happened (theoretical).
They listed the following anecdotal adverse events:
urethral irritation needing temporary catheterisation
stress incontinence.
They listed the following theoretical adverse events:
perforation or injury of surrounding structures such as rectum external sphincter, urethra, neurovascular bundles
recto urethral fistula
failure to void after catheter removal
staff risks if the laser protocol not followed appropriately.
20 professional expert questionnaires for this procedure were submitted. Find full details of what the professional experts said about the procedure in the specialist advice questionnaires for this procedure.
Validity and generalisability
There are 2 small RCTs comparing TPLA with TURP with outcomes reported at 12 months follow up.
The study by Canat (2023) described simple 1:1 randomisation to TPLA or TURP according to order of admission, so there was no allocation concealment. Although most of the characteristics were similar between the groups at baseline, those assigned to the TPLA group had a statistically significantly higher American Society of Anesthesiologists score (p=0.03).
Evidence is mainly from small observational studies with short-term follow up and most of the studies were done in Italy.
There is a lack of medium- and long-term follow up.
No significant modifications of the device or surgical technique were reported.
Registry
Professional experts stated that data on these procedures are added to the existing European data registry for TPLA BPH treatment.
Any ongoing trials
NCT03776006: Registry of transperineal laser ablation for treatment of LUTS with use of the Echolaser device. A multicentre, international registry to evaluate the treatment of lower urinary tract symptoms in terms of long-term efficacy, functional outcomes and safety. The long-term efficacy of TPLA for LUTS will be measured by the time until surgical retreatment. Follow-up 5 years; Study completion date 2029. Sponsor: Amsterdam University Medical Centers, University of Amsterdam.
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