A randomized controlled trial evaluating low-intensity shockwave therapy for treatment of persistent storage symptoms following transurethral surgery for benign prostatic obstruction

After BPO surgery, 20–30% of patients still have persistent storage symptoms [3, 4]. MRAs or ß3-agonizts are the main treatment line, however these medications may result in bothersome adverse effects that might affect patients‘ compliance [9]. Therefore, an alternative and effective treatment option that lacks those adverse effects would be valuable tool. Li-SWT is a non-invasive treatment which will likely improve bladder function through angiogenesis, nerve regeneration and suppression of inflammation [11, 12]. There are some clinical studies that used Li-SWT to treat LUTS [19]. However, no study has been conducted using Li-SWT to treat post prostatectomy storage symptoms.

In 2019, Zhang et al. used radial extracorporeal SW therapy through perineal approach to treat patients with benign prostatic hyperplasia [15]. The patients received 2000 shocks, once/week for 8 weeks, at two bar and frequency of 10 Hz. The study revealed significant improvement compared to baseline in IPSS and QoL score at 4 weeks and became sustained through the 3-month follow-up.

In 2021, Lu et al. compared the effect of 8-weekly sessions of Li-SWT versus sham on females with OAB [16]. Focused SWs were applied through suprapubic approach using 3000 shocks/session, energy flux density of 0.25 mJ/mm2 and frequency of 3 Hz. The authors found that Li-SWT achieved significant improvement in OABSS, daytime frequency and QoL questionnaire at 4 weeks compared to sham and significant improvement in average voided volume/micturition, functional bladder capacity and all OABS at 8 weeks. This improvement remained constant till 6 months after treatment.

Herein, Li-SWT was associated with significant improvement in OABSS, daytime frequency, urgency, urgency incontinence, average voided volume/micturition and QoL score compared to sham. The three approaches of Li-SWT had similar efficacy apart from significantly higher percent reduction in OABSS at 3-month follow-up in perineal compared to suprapubic approach.

Solifenacin improves persistent storage symptoms after prostatectomy [20, 21]. In the present study, solifenacin 10 mg improved all OABS apart from nocturia, with comparable efficacy to Li-SWT. The dose of 10 mg was used because all included patients had tried initially different treatment regimens including solifenacin 5 mg. Two weeks washout period was offered to all patients before randomization.

Unlike previous studies [16, 22], there was no significant improvement in nocturia in Li-SWT and solifenacin groups in the current study. However, Iselin et al. similarly showed that the use of oxybutynin early after transurethral resection of the prostate improved storage symptoms except for nocturia [23]. This might be secondary to the difference in study population and pathophysiology of nocturia [24].

In the current study, the change in OABSS was compared using both actual and percent reduction from baseline, and the significance was similar in both. The primary end point was considered as the percent reduction in OABSS at 3-months resembling the study of Liu et al. [18] that used it to express the effect of solifenacin in OAB patients.

Unlike data of Zhang et al. [15] and Lu et al. [16], the current study revealed that Li-SWT had no effect on Qmax and PVR. Nevertheless, the study of Zhang et al. was a non-randomized trial including patients with benign prostatic hyperplasia and the effect on Qmax and PVR was assessed at 4 and 8 weeks only. Along with the current study, a recent meta-analysis found that Li-SWT does not improve Qmax and PVR compared to sham in patients with chronic pelvic pain syndrome [19]. Also, solifenacin does not affect Qmax and PVR in OAB patients [25], and similar results were found in the present study.

Considering urodynamic changes, the impact of Li-SWT and solifenacin on bladder function was assessed among responders at 6-months. Both treatment modalities could increase cystometric capacity at first sensation of filling. Li-SWT resulted in significant decrease in the percent of patients who had DO compared to baseline (19.6% versus 39.2%).

The safety of Li-SWT was documented by previous studies [15, 16, 19] and confirmed by the present study. Zhang et al. reported slight perineal pain after perineal application of radial extracorporeal SW therapy [15]. Also, the pain score in the present study was significantly higher in perineal and combined approaches than suprapubic approach. This may be due to compression of the tissues against pelvic bones. Chapple et al. reported 27.7% dry mouth and 6.8% discontinuation rate with solifenacin 10 mg [22], and it was 46.2% and 11.5% respectively in the current study.

Up to date, there is no ideal treatment protocol for Li-SWT regarding application site, energy flux density, number of shocks and sessions and time interval between sessions. Also, there were no reported difference among SW energy generators and handles [26]. Following this trial, the combined approach including all the focal areas through perineal and suprapubic approaches was protocoled in our institute. This could maximize efficacy and reduce pain. Patients with post prostatectomy persistent storage symptoms will be offered Li-SWT whenever they fail or experience adverse effects with bladder targeting medicines.

Study’s limitations include the short-term follow-up. Moreover, proper assessment of nocturia was not performed and QoL was evaluated by a single question rather than specific QoL questionnaires. Lack of evaluation of the cost difference between the two treatment modalities is another limitation.

Nevertheless, the present study is the first trial evaluating the efficacy of Li-SWT on persistent storage symptoms after BPO surgery. Trying different approaches of Li-SWT provided valuable information and the use of focused SWs was helpful to avoid dispersion of SWs [27]. Herein, the use of urodynamic evaluation objectively confirmed the theory. Therefore, this study serves as a motive for further clinical trials examining the need for more SW sessions on long term. Also, the use of color doppler ultrasound might be useful in future studies to define the impact of Li-SWT on bladder vascularity.

In conclusion, Li-SWT is effective and safe treatment method for persistent storage symptoms after TUS for BPO. It ameliorates OABS including frequency, urgency and urgency incontinence and improves QoL. It can be used as an alternative option to MRAs with similar efficacy and less bothersome adverse effects.

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