Hypothesis / aims of study
Modern medicine faces a persistent challenge in the management of chronic prostatitis (CP) and chronic pelvic pain syndrome (CPPS) due to the absence of standardized treatment protocols and their considerable impact on quality of life. To evaluate the long-term effects of combined extracorporeal shock wave therapy (ESWT) and bovhyaluronidase azoximer (BA) as part of comprehensive therapy in patients with chronic bacterial prostatitis, CP/CPPS IIIA–IIIB.
Study design, materials and methods
An open-label, randomized, placebo-uncontrolled study included 116 men (mean age 45.5±9.5 years, mean disease duration 20.8±7.7 months) diagnosed with CP or CPPS. According to the NIDDK/NIH classification, CP II was verified in 37 cases (32%), CP/CPPS IIIA in 39 (33.6%), and CP/CPPS IIIB in 40 (34.4%).
Three groups were formed: Group 1 (n = 37) – CP II : ESWT combined with standard “3-As” therapy (antibiotic, NSAID, α-blocker); Group 2 (n = 38) – CP/CPPS IIIA–IIIB: ESWT monotherapy; Group 3 (n = 41) –CP/CPPS IIIA–IIIB: ESWT combined with BA.
ESWT sessions (Dornier Aries, 2000–4000 impulses) were applied to the perineum twice weekly for a total of 12 sessions. Assessments were performed at baseline and at weeks 7, 10, 18, 30, and 54 using the NIH-CPSI, IPSS, IIEF-5, and VAS scales; uroflowmetry (UFM); transrectal ultrasonography (TRUS) with elastography and Doppler; and laboratory tests.
Results
All patients completed the full course of treatment without adverse effects. By week 7, Group 1 demonstrated more pronounced improvement in NIH-CPSI, IPSS, VAS, and UFM parameters (p<0.05). Between weeks 10 and 54, positive dynamics were recorded in all groups, with the most stable and significant improvement in Group 3, which showed a reduction in fibrotic areas and calcifications, an increase in zones of normal elasticity, and improved blood flow parameters (p<0.05). Intergroup analysis confirmed the superiority of Groups 1 and 3 over Group 2 (p<0.05), with no significant differences between Groups 1 and 3 in NIH-CPSI, IPSS, or VAS scores (p>0.05). In patients with non-inflammatory CP/CPPS (IIIB), erectile function also improved significantly according to IIEF-5 (p<0.05).
Interpretation of results
The proposed therapeutic approaches for CP and CPPS demonstrate safety and clinical efficacy, contributing to the reduction of symptoms and improvement of prostate morphofunctional parameters. In long-term follow-up, both ESWT and BA showed high effectiveness in the lysis of fibrotic zones and prostatic calcifications, as well as in the sustained alleviation of CP/CPPS symptoms.