Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Bladder Outlet Obstruction
Conditions
Keywords
Intravesical prostatic protrusion, Transabdominal ultrasound, Prostate ultrasound, International Prostate Symptom Score, Quality of life, Uroflowmetry, Maximum urinary flow rate, Post-void residual urine, Detrusor wall thickness
Brief summary
This prospective cohort study evaluated whether transabdominal ultrasound measurement of intravesical prostatic protrusion predicts symptom severity and response to medical therapy in men aged 50 years or older with lower urinary tract symptoms secondary to benign prostatic hyperplasia. At baseline, participants underwent clinical evaluation, laboratory assessment including prostate-specific antigen, symptom scoring using the International Prostate Symptom Score and quality of life index, uroflowmetry, and transabdominal ultrasonography to measure prostate volume, bladder parameters, post-void residual urine, detrusor wall thickness, and intravesical prostatic protrusion. Participants were grouped by intravesical prostatic protrusion grade (less than 5 millimetres, 5 to 10 millimetres, and greater than 10 millimetres) and were followed for six months with reassessments at three and six months to evaluate response to medical therapy and identify patients who required escalation of treatment or surgical intervention.
Interventions
Transabdominal ultrasonography; TAUS; Ultrasound IPP measurement Intervention Description: Intravesical prostatic protrusion was measured using transabdominal ultrasonography in the midsagittal plane at a bladder volume of approximately 100-200 millilitres. The measurement was defined as the distance (millimetres) from the bladder neck to the tip of the protruding prostatic tissue, and participants were categorized into Grade I (\<5 millimetres), Grade II (5-10 millimetres), or Grade III (\>10 millimetres). Ultrasound assessment was performed at baseline and during follow-up per protocol.
Participants received an alpha-adrenergic blocker as part of standard medical therapy for benign prostatic hyperplasia-related lower urinary tract symptoms. The specific agent, dose, dosing frequency, and duration were prescribed by the treating urologist and recorded throughout follow-up.
Participants received a 5-alpha reductase inhibitor as part of standard medical therapy for benign prostatic hyperplasia-related lower urinary tract symptoms. The specific agent, dose, dosing frequency, and duration were prescribed by the treating urologist and recorded throughout follow-up.
Sponsors
Study design
Eligibility
Inclusion criteria
* Male participants aged 50 years or older. * Lower urinary tract symptoms secondary to benign prostatic hyperplasia. * Moderate to severe symptoms with International Prostate Symptom Score 15 to 35. * Prostate volume 30 to 100 millilitres. * Maximum urinary flow rate less than 15 millilitres per second. * No hydronephrosis due to bladder outlet obstruction. * Normal prostate-specific antigen or normal free-to-total prostate-specific antigen ratio.
Exclusion criteria
* History of prostate, bladder, or lower urinary tract surgery. * Neurological disease affecting lower urinary tract function. * Active urinary tract infection and/or symptomatic urinary tract stones. * Post-void residual urine volume greater than 200 millilitres. * Urethral stricture. * Prostate cancer or bladder cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in International Prostate Symptom Score | Baseline and 6 months | The International Prostate Symptom Score was used to quantify lower urinary tract symptom severity. The outcome was the change in total score between baseline (pre-treatment) and the 6-month follow-up visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in maximum urinary flow rate | Baseline and 6 months | Change in maximum urinary flow rate measured by uroflowmetry between baseline and 6 months. |
| Change in post-void residual urine volume | Baseline and 6 months | Change in post-void residual urine volume measured by transabdominal ultrasonography between baseline and 6 months. |
| Change in detrusor wall thickness | Baseline and 6 months | Change in detrusor wall thickness measured by transabdominal ultrasonography between baseline and 6 months. |
| Need for escalation of management during follow-up | Up to 6 months | Proportion of participants who required escalation of management during follow-up (for example, change or intensification of medical therapy or referral for surgical management) due to persistent symptoms or poor objective improvement. |
| Change in quality of life score | Baseline and 6 months | Change in the quality of life index associated with the International Prostate Symptom Score between baseline and 6 months. |
Countries
Egypt