An interventional study of non-ablative SMOOTH mode Erbium YAG laser and Tadalafil 5mg in Chronic Prostatitis With Chronic Pelvic Pain Syndrome and Prostatodynia, sponsored by Adrian Gaspar. Completed at 1 site in Argentina. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-25.
Sponsored by Adrian Gaspar · Not applicable, Interventional, and Treatment
This prospective study aimed to compare the clinical outcomes between the use of the erbium: YAG (Er:YAG) laser, intraurethrally administered in long non-ablative SMOOTH™ train of pulses applied at the level of the male prostatic urethra, to the use of the pharmacological treatment of oral tadalafil for the treatment of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). The results show that both treatments are effective in alleviating symptoms of CP/CPPS. The non-ablative Er:YAG SMOOTHTM laser seems to be a promising treatment for this widely spread condition. More studies are needed to confirm its safety and efficacy.
Prostatitis is the most common diagnosis (>50%) in men visiting outpatient urological clinics .
The NIH classification classifies prostatitis into 4 types: category I - acute bacterial prostatitis, which is very rare, affecting only up to 5% of patients; category II- chronic bacterial prostatitis, also affecting up to 5% of patients; category III- chronic nonbacterial prostatitis/chronic pelvic pain syndrome (CP/CPPS), which is the most common, as it affects 90%-95% of cases; and Category IV- asymptomatic inflammatory prostatitis, which has unknown prevalence and also unknown clinical significance.
Although category III or CP/CPPS is the most prevalent form of prostatitis, its causes are largely unknown and treatments often fail to alleviate symptoms in the long term. In contrast, patients suffering from type I and II prostatitis are successfully treated with antibiotics, as a uropathogen or an infectious agent is usually identified as the cause .
CP/CPPS is characterized by pain in the perineum and tenderness in the prostate and various urological symptoms (urgency, frequency, low urethral pressure) and sometimes also ejaculatory symptoms, such as painful ejaculation.
Currently used treatments for CP/CPPS are mainly pharmacological, including alpha blockers, 5-alpha reductase inhibitors, anti-inflammatories, antibiotics, phytotherapy, allopurinol, botulinum toxin and traditional Chinese medicine . Non-pharmacological therapies include acupuncture, prostatic massage, extracorporeal shockwave therapy, pulsed magnetic field therapy, transrectal and transurethral thermotherapy and others . Some of the abovementioned therapies alleviate symptoms by improving vascularisation and blood flow of the prostate and peri-prostatic area. This is also the mechanism of action of the erbium:YAG (Er:YAG) laser with non-ablative SMOOTH™ mode - it works by thermal pulsing of the treated surface, with microsecond-range long pulses combined into long (several hundred millisecond range) sequences. Each laser micropulse sharply increases tissue temperature and acts as a stimulative trigger. Long pulse trains cause slower diffusion of heat to deeper layers of the skin or mucosa, causing initially vasodilation and then collagen remodelling and stimulation of fibroblasts with collagen remodelling. It has shown to improve vascularisation and alleviate symptoms of genitourinary syndrome of menopause (GSM) in women, including irritation, dryness and pain. It has also been used intraurethrally in women to alleviate urinary symptoms of GSM. Intraurethral thermal therapy has been previously shown promising in the treatment of CP/CPPS in men. In this study the investigators aimed to assess the safety and effectiveness of transurethral non-ablative Er:YAG laser therapy applied at the level of the male prostatic urethra and to compare it with pharmacological treatment of 5 mg oral tadalafil for the treatment of CP/CPPS.
88 studies on the registry are indexed under Prostatitis; 11 are open to participants now.
This study's enrollment of 36 is below the median of 60 across 73 interventional studies indexed under Prostatitis.
Browse Prostatitis studies →Adrian Gaspar is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
In the laser group, the patients received two sessions of Er:YAG intraurethral laser in non-ablative SMOOTH™ mode, with 1 month interval between sessions.
Device: non-ablative SMOOTH mode Erbium YAG laser
The tadalafil group was treated with daily oral administration of tadalafil, at a dose of 5 mg/day, which lasted consecutively for two months.
Drug: Tadalafil 5mg
Erbium:YAG (Er:YAG) laser with non-ablative SMOOTH™ mode
oral tadalafil 5 mg was administered daily over a period of two months
Maximum urethral flow value (Q-max)
measurement of maximum urethral flow using uroflowmetry
Time frame: Change from Baseline Q-max at 3 and 6 months following the intervention
IPSS questionnaire
Assessment of urinary symptoms using the International Prostate Symptom Score (IPSS)
Time frame: Change from Baseline IPSS score at 1, 3, 6 and 12 months following the intervention
pain assesment: VAS (visual analog scale) scale
subjective assesment of pain using 0 (minimum) to 10 (maximum) VAS scale. 0 means no pain, 10 means worst possible pain;
Time frame: Change from Baseline pain VAS score at 1, 3, 6 and 12 months following the intervention
dysuria assesment: VAS (visual analog scale) scale
subjective assesment of dysuria using 0 (minimum) to 10 (maximum) VAS scale. 0 means no dysuria, 10 means worst possible dysuria;
Time frame: Change from Baseline dysuria VAS score at 1,3, 6 and 12 months following the intervention
Patient satisfaction: 7-point Likert Scale
subjective assessment of patients' satisfaction with the treatment using 0 to 6 Likert Scale; Question - How satisfied are you with the treatment? Likert scale: 0 - extremely satisfied; 1- very satisfied; 2 - mostly satisfied; 3 - neither satisfied nor unsatisfied; 4 - mostly unsatisfied; 5 - very unsatisfied; 6- extremely unsatisfied
Time frame: 6 months following the intervention
Patient satisfaction: 7-point Likert Scale
subjective assessment of patients' satisfaction with the treatment using 0 to 6 Likert Scale; Question - How satisfied are you with the treatment? Likert scale: 0 - extremely satisfied; 1- very satisfied; 2 - mostly satisfied; 3 - neither satisfied nor unsatisfied; 4 - mostly unsatisfied; 5 - very unsatisfied; 6- extremely unsatisfied
Time frame: 12 months following the intervention
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2017 to primary completion in Nov 2018, 20 months.
Of 21 interventional studies with no phase under Prostatitis, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 25. This study's 20 months is close to that.
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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Adrian Gaspar