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

NCT04446598 | Completed

• 1 other identifier: CPPS/CP-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Prostatitis With Chronic Pelvic Pain Syndrome; Prostatodynia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• pain assesment: VAS (visual analog scale) scale

  Change from Baseline pain VAS score at 1, 3, 6 and 12 months following the intervention

• dysuria assesment: VAS (visual analog scale) scale

  Change from Baseline dysuria VAS score at 1,3, 6 and 12 months following the intervention

• Patient satisfaction: 7-point Likert Scale

  6 months following the intervention

• Patient satisfaction: 7-point Likert Scale

  12 months following the intervention

Study Arms (2)

Laser group

EXPERIMENTAL

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

Tadalafil group

ACTIVE COMPARATOR

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

Interventions

non-ablative SMOOTH mode Erbium YAG laser DEVICE

Erbium:YAG (Er:YAG) laser with non-ablative SMOOTH™ mode

Laser group

Tadalafil 5mg DRUG

oral tadalafil 5 mg was administered daily over a period of two months

Tadalafil group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Adrian Gaspar: lead

Study Sites (1)

Uroclinica

Mendoza, Argentina

Location

MeSH Terms

Conditions

Prostatitis

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 25, 2020
• Study Start: March 13, 2017
• Primary Completion: November 30, 2018
• Study Completion: December 31, 2018
• Last Updated: June 25, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)