Benign prostatic hyperplasia, Overactive Bladder Urological and Genital Diseases Benign prostatic hyperplasia, Overactive Bladder
Conditions
Interventions
This study involves two study arms, one clinical and one molecular.
Arm 1: Clinical
Potential participants are identified during an assessment in the male Lower Urinar
Sponsors
Aristotele University of Thessaloniki
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Treatment arms (Group 1 and 2): 1. Treatment-naïve men 2. Age 50 years or older 3. Predominantly storage LUTS as defined by the IPSS (storage subscore = voiding subscore and score = 3 in the urgency question) and at least 3 urgency episodes per 24h as documented in a 3-day bladder diary 4. Prostate volume =30ml 5. Maximum flow rate (Qmax) =10ml/s 6. Post-void residual (PVR)=100ml 7. PSA value = 4 ng/ml. Patients with positive DRE and/or PSA values 4-10ng/ml are included only after negative prostate biopsy. Control group 1: 1. Treatment-naïve men 2. Age 50 years or older 3. Predominantly storage LUTS as defined by the IPSS (storage subscore = voiding subscore and score = 3 in the urgency question) and at least 3 urgency episodes per 24h as documented in a 3-day bladder diary 4. Prostate volume = 30ml 5. Maximum flow rate (Qmax) = 10ml/s 6. Post-void residual (PVR) = 100ml 7. PSA = 4ng/ml. Patients with positive DRE and/or PSA values 4-10bng/ml are included only after negative prostate biopsy 8. Consent to provide prostate or bladder tissue Control group 2 and 3: Asymptomatic men 1. Treatment-naïve men 2. Age 50 years or older 3. Total IPSS <7 and/or a score of 0-1 in the IPSS ‘urgency’ question. 4. Prostate volume = 30ml 5. Maximum flow rate (Qmax) = 10ml/s 6. Post-void residual (PVR) = 100ml 7. PSA = 4ng/ml. Patients with positive DRE and/or PSA values 4-10 ng/ml were included only after negative prostate biopsy.
Exclusion criteria
Exclusion criteria: 1. Patients with neurogenic lower urinary tract dysfunction 2. Patients with a history of urinary tract malignancy 3. Any contraindication to the use of a-blockers or antimuscarinics 4. Metabolic conditions that may affect lower urinary tract (LUT) function 5. Psychiatric illnesses 6. Chronic kidney, hepatic or cardiac failure 7. History of urinary stone disease 8. History of urethral instrumentation 9. Urethral stricture 10. Acute urinary tract infection (UTI) or history of recurrent UTI’s 11. Use of medications known to affect LUT function including PDE-5 inhibitors 12. Positive urine culture 13. Microscopic haematuria, proteinuria or glucosuria. Subjects with pyuria were included only after a negative urine culture.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Muscarinic receptor expression is measured using the immunohistochemistry (Western Blot and RT-PCR) at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Urinary symptoms are measured using IPSS Questionnaire at three and six months 2. Storage ability is measured using IPSS Questionnaire Storage subscale at three and six months 3. Amount of prostate specific antigen (PSA) in the blood is measured using standard laboratory biochemistry tests at three and six months 4. Semen parameters are measured using standard laboratory biochemistry tests at three and six months 5. Total prostate and adenoma volume is measured using Transabdominal and transrectal ultrasonography at three and six months 6. Quality of life is measured using the QoL question of the IPSS at three and six months 7. Adrenergic receptor expression in prostate and bladder is measured using immunohistochemistry (Western Blot and RT-PCR) at six months 8. Sensory receptor TRPV1 expression is measured using immunohistochemistry (Western Blot and RT-PCR) at six months 9. eNOS and VEGF expression in prostate and bladder using immunohistochemistry (Western Blot and RT-PCR) at six months | — |
Countries
Greece
Outcome results
None listed