Management of Prostatodynia in Younger Patients With Non-ablative Erbium:YAG Intraurethral Laser

Non Ablative Erbium:YAG Laser Transurethral Treatment for Chronic Prostatitis/Chronic Pelvic Pain Syndrome in Younger Patients: a Prospective Comparative Study

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.

Study Overview

• Status: Completed
• Conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome; Prostatodynia
• Intervention / Treatment: Device: non-ablative SMOOTH mode Erbium YAG laser; Drug: Tadalafil 5mg

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Mendoza, Argentina
    • Uroclinica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• clinical diagnosis of chronic prostatitis/chronic pelvic pain syndrome with characteristic symptoms of perineal pain and urinary symptoms of dysuria and urinary frequency;
• negative urine culture after prostatic massage; prostatic volume less than 50 cc in prostatic ultrasound;
• obstructive uroflowmetric pattern with a Q-max value between 10 and 15 ml/sec

Exclusion Criteria:

• age over 50 years
• current or recent (last 6 months) pharmacological or other therapies of CP/CPPS

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser group; 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; Erbium:YAG (Er:YAG) laser with non-ablative SMOOTH™ mode
Active Comparator: Tadalafil group; 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; oral tadalafil 5 mg was administered daily over a period of two months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum urethral flow value (Q-max)	measurement of maximum urethral flow using uroflowmetry	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)	Change from Baseline IPSS score at 1, 3, 6 and 12 months following the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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;	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;	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	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	12 months following the intervention

Collaborators and Investigators

• Sponsor: Adrian Gaspar

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2017
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (Actual): June 25, 2020

Study Record Updates

• Last Update Posted (Actual): June 25, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Disease; Prostatic Diseases; Syndrome; Chronic Disease; Pelvic Pain; Prostatitis; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Tadalafil
• Other Study ID Numbers: CPPS/CP-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No