Mohammed Hegazy et al., 2024: A randomized controlled trial evaluating low-intensity shockwave therapy for treatment of persistent storage symptoms following transurethral surgery for benign prostatic obstruction

Wednesday, 02 October 2024

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Mohammed Hegazy 1 , Khaled Z Sheir 1 , Mohamed A Gaballah 1 , Ahmed M Elshal 2
1Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.
2Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.

Abstract

Background: Low-intensity shockwave therapy (Li-SWT) can improve bladder function through enhancement of angiogenesis and nerve regeneration and suppression of inflammation and overactivity. In this trial, we aimed to evaluate the efficacy of Li-SWT on persistent storage symptoms after transurethral surgery (TUS) for benign prostatic obstruction (BPO).

Methods: Between July 2020 and July 2022, 137 patients with persistent storage symptoms; urgency episodes/24 h ≥ 1 and daytime frequency ≥8, for at least three months after TUS for BPO were randomly allocated to Li-SWT versus sham versus solifenacin 10 mg/day in 3:1:1 ratio. The primary end point was the percent reduction from baseline in overactive bladder symptom score (OABSS) at 3-month follow-up. The changes in 3-day voiding diary parameters, quality of life (QoL) score, peak flow rate and residual urine at 3 and 6-month follow-up were compared. Treatment-related adverse effects were also evaluated.

Results: Baseline data were comparable between groups. The percent reduction from baseline in OABSS at 3-month follow-up was significantly higher in Li-SWT compared to sham (-55% versus -11%), and it was comparable between Li-SWT and solifenacin-10 (-55% versus -60%). Li-SWT achieved significant improvement like solifenacin-10 in 3-day voiding diary parameters and QoL score at 3-month follow-up. This improvement remained comparable between Li-SWT and solifenacin-10 at 6-month follow-up. No adverse effects related to Li-SWT were noted apart from tolerable pain during the procedure. Solifenacin-10 was associated with bothersome adverse effects in 73% of the patients with 11.5% discontinuation rate.

Conclusions: Li-SWT ameliorates persistent storage symptoms and promotes QoL after TUS for BPO, with comparable efficacy and better tolerance compared to solifenacin.

Prostate Cancer Prostatic Dis. 2024 Mar 29. doi: 10.1038/s41391-024-00820-4. Online ahead of print. PMID: 38553627

Comments 1

Jens Rassweiler on Wednesday, 02 October 2024 11:00

This article discusses a randomized controlled trial that investigated the efficacy of low-intensity shockwave therapy (Li-SWT) for treating persistent storage symptoms following transurethral surgery (TUS) for benign prostatic obstruction (BPO). Despite TUS, 20-30% of patients experience persistent lower urinary tract symptoms (LUTS), such as urgency and frequent urination, which negatively affect their quality of life (QoL). Conventional treatments like muscarinic receptor antagonists (MRAs) or ß3-agonists often come with side effects, including dry mouth, constipation, and dizziness.
Objective:
The trial aimed to assess whether Li-SWT could provide symptom relief as effectively as solifenacin (a common MRA) while avoiding adverse effects.
Methodology:
Conducted between July 2020 and July 2022, the study included 137 patients with persistent storage symptoms post-TUS.
The patients were randomized into three groups:
1. Li-SWT group: Treated with 8 weekly Li-SWT sessions.
2. Sham group: Received sham treatment.
3. Solifenacin group: Received 10 mg of solifenacin daily.
Li-SWT was applied through suprapubic, perineal, or combined approaches using Dornier AR2 SW device (Dornier MedTech, Wessling, Germany) with a focused SW source

The primary outcome was a reduction in the overactive bladder symptom score (OABSS) after three months.
Results:
• Li-SWT significantly reduced OABSS by 55%, outperforming the sham group (11%) and showing similar efficacy to the solifenacin group (60%).
• The proportion of responders (patients with a clinically significant reduction in OABSS) was higher in the Li-SWT group (80.3%) compared to the sham group (23.8%), but similar to the solifenacin group (73.1%).
• The treatment also improved other secondary outcomes such as daytime frequency, urgency, and urgency incontinence. However, Li-SWT had no significant impact on nocturia, maximum urinary flow rate (Qmax), or post-voiding residual urine (PVR).
• After six months, the efficacy of Li-SWT remained comparable to solifenacin.

Safety:
Li-SWT had minimal adverse effects, with only mild local pain reported during the procedure, while 73% of patients on solifenacin experienced side effects like dry mouth. Li-SWT provided a less bothersome alternative to MRAs.
Conclusion:
Li-SWT is a safe and effective non-invasive treatment for persistent storage symptoms after TUS for BPO. It provides similar benefits to solifenacin but with fewer side effects, offering an alternative for patients who cannot tolerate MRAs. Further research could explore its long-term efficacy and application methods. This is one of the first randomized trials focusing on this new indication for Li-SWT.

Jens Rassweiler

The primary outcome was a reduction in the overactive bladder symptom score (OABSS) after three months.
Results:
•	Li-SWT significantly reduced OABSS by 55%, outperforming the sham group (11%) and showing similar efficacy to the solifenacin group (60%).
•	The proportion of responders (patients with a clinically significant reduction in OABSS) was higher in the Li-SWT group (80.3%) compared to the sham group (23.8%), but similar to the solifenacin group (73.1%).
•	The treatment also improved other secondary outcomes such as daytime frequency, urgency, and urgency incontinence. However, Li-SWT had no significant impact on nocturia, maximum urinary flow rate (Qmax), or post-voiding residual urine (PVR).
•	After six months, the efficacy of Li-SWT remained comparable to solifenacin.

[img]https://www.storzmedical.com/images/blog/Hegazy.PNG[/img]
Safety:
Li-SWT had minimal adverse effects, with only mild local pain reported during the procedure, while 73% of patients on solifenacin experienced side effects like dry mouth. Li-SWT provided a less bothersome alternative to MRAs.
Conclusion:
Li-SWT is a safe and effective non-invasive treatment for persistent storage symptoms after TUS for BPO. It provides similar benefits to solifenacin but with fewer side effects, offering an alternative for patients who cannot tolerate MRAs. Further research could explore its long-term efficacy and application methods. This is one of the first randomized trials focusing on this new indication for Li-SWT.

Jens Rassweiler

This article discusses a randomized controlled trial that investigated the efficacy of low-intensity shockwave therapy (Li-SWT) for treating persistent storage symptoms following transurethral surgery (TUS) for benign prostatic obstruction (BPO). Despite TUS, 20-30% of patients experience persistent lower urinary tract symptoms (LUTS), such as urgency and frequent urination, which negatively affect their quality of life (QoL). Conventional treatments like muscarinic receptor antagonists (MRAs) or ß3-agonists often come with side effects, including dry mouth, constipation, and dizziness. Objective: The trial aimed to assess whether Li-SWT could provide symptom relief as effectively as solifenacin (a common MRA) while avoiding adverse effects. Methodology: Conducted between July 2020 and July 2022, the study included 137 patients with persistent storage symptoms post-TUS. The patients were randomized into three groups: 1. Li-SWT group: Treated with 8 weekly Li-SWT sessions. 2. Sham group: Received sham treatment. 3. Solifenacin group: Received 10 mg of solifenacin daily. Li-SWT was applied through suprapubic, perineal, or combined approaches using Dornier AR2 SW device (Dornier MedTech, Wessling, Germany) with a focused SW source The primary outcome was a reduction in the overactive bladder symptom score (OABSS) after three months. Results: • Li-SWT significantly reduced OABSS by 55%, outperforming the sham group (11%) and showing similar efficacy to the solifenacin group (60%). • The proportion of responders (patients with a clinically significant reduction in OABSS) was higher in the Li-SWT group (80.3%) compared to the sham group (23.8%), but similar to the solifenacin group (73.1%). • The treatment also improved other secondary outcomes such as daytime frequency, urgency, and urgency incontinence. However, Li-SWT had no significant impact on nocturia, maximum urinary flow rate (Qmax), or post-voiding residual urine (PVR). • After six months, the efficacy of Li-SWT remained comparable to solifenacin. [img]https://www.storzmedical.com/images/blog/Hegazy.PNG[/img] Safety: Li-SWT had minimal adverse effects, with only mild local pain reported during the procedure, while 73% of patients on solifenacin experienced side effects like dry mouth. Li-SWT provided a less bothersome alternative to MRAs. Conclusion: Li-SWT is a safe and effective non-invasive treatment for persistent storage symptoms after TUS for BPO. It provides similar benefits to solifenacin but with fewer side effects, offering an alternative for patients who cannot tolerate MRAs. Further research could explore its long-term efficacy and application methods. This is one of the first randomized trials focusing on this new indication for Li-SWT. Jens Rassweiler

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