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

Primary Purpose

Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Prostatodynia

Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
non-ablative SMOOTH mode Erbium YAG laser
Tadalafil 5mg
Sponsored by
Adrian Gaspar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Uroclinica

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laser group

Tadalafil group

Arm Description

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.

The tadalafil group was treated with daily oral administration of tadalafil, at a dose of 5 mg/day, which lasted consecutively for two months.

Outcomes

Primary Outcome Measures

Maximum urethral flow value (Q-max)
measurement of maximum urethral flow using uroflowmetry
IPSS questionnaire
Assessment of urinary symptoms using the International Prostate Symptom Score (IPSS)

Secondary Outcome Measures

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;
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;
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
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

Full Information

First Posted
June 3, 2020
Last Updated
June 23, 2020
Sponsor
Adrian Gaspar
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1. Study Identification

Unique Protocol Identification Number
NCT04446598
Brief Title
Management of Prostatodynia in Younger Patients With Non-ablative Erbium:YAG Intraurethral Laser
Official Title
Non Ablative Erbium:YAG Laser Transurethral Treatment for Chronic Prostatitis/Chronic Pelvic Pain Syndrome in Younger Patients: a Prospective Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 13, 2017 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Adrian Gaspar

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Prostatodynia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser group
Arm Type
Experimental
Arm Description
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.
Arm Title
Tadalafil group
Arm Type
Active Comparator
Arm Description
The tadalafil group was treated with daily oral administration of tadalafil, at a dose of 5 mg/day, which lasted consecutively for two months.
Intervention Type
Device
Intervention Name(s)
non-ablative SMOOTH mode Erbium YAG laser
Intervention Description
Erbium:YAG (Er:YAG) laser with non-ablative SMOOTH™ mode
Intervention Type
Drug
Intervention Name(s)
Tadalafil 5mg
Intervention Description
oral tadalafil 5 mg was administered daily over a period of two months
Primary Outcome Measure Information:
Title
Maximum urethral flow value (Q-max)
Description
measurement of maximum urethral flow using uroflowmetry
Time Frame
Change from Baseline Q-max at 3 and 6 months following the intervention
Title
IPSS questionnaire
Description
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
Secondary Outcome Measure Information:
Title
pain assesment: VAS (visual analog scale) scale
Description
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
Title
dysuria assesment: VAS (visual analog scale) scale
Description
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
Title
Patient satisfaction: 7-point Likert Scale
Description
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
Title
Patient satisfaction: 7-point Likert Scale
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Uroclinica
City
Mendoza
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
No

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

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