Treatment for erectile dysfunction in patients with benign prostate enlargement or chronic prostatitis/chronic pelvic pain syndrome Urological and Genital Diseases
Conditions
Interventions
The purpose of this clinical trial is to investigate the effect of the out-of-hospital treatment with Thermobalancing therapy and Dr Allen's Device for Prostate Treatment on erectile dysfunction, the
Sponsors
Fine Treatment (United Kingdom)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Aged between 40 and 55 with ED due to CP/CPPS or BPH
Exclusion criteria
Exclusion criteria: 1. Previous prostate surgeries 2. Infectious diseases 3. Severe comorbidities, such as cancer, heart failure, and end-stage chronic diseases 4. Cognitive impairment 5. Mental illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following outcomes will be assessed three times in total, before, during and at the end of the treatment period: 1. Severity of erectile dysfunction measured using the International Index of Erectile Function (IIEF-5) Questionnaire 2. Volume of the prostate gland measured using ultrasound 3. Severity of urinary symptoms measured using the AUA Symptom Score Questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| The following outcomes will be assessed three times in total, before, during and at the end of the treatment period: 1. Health-related quality of life (HRQoL) measured using the Short Form Survey Instrument (SF-36) 2. Serum levels of prostate-specific antigen, total testosterone, and 17ß-estradiol (E2) measured using blood samples and standard techniques | — |
Countries
Pakistan
Contacts
Public ContactAriana Adjani
Outcome results
None listed