Patient‐reported outcomes in men with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) treated with intraprostatic OnabotulinumtoxinA: 3‐month results of a prospective single‐armed cohort study
Authors: Sacco Emilio , Bientinesi Riccardo , Marangi Francesco , Totaro Angelo , D'Addessi Alessandro , Racioppi Marco , Pinto Francesco , Vittori Matteo , Bassi Pierfrancesco 
Published: June 2012

Study Type – Therapy (prospective cohort)Level of Evidence 3aWhat's known on the subject? and What does the study add?Several short‐term studies have shown that intraprostatic injection of botulinum toxin (BTX) improves lower urinary tract symptoms and flow parameters in patients with BPH, but information on patient‐reported outcomes is lacking.The present study provides useful data on patient‐perceived level of improvement and effectiveness of intraprostatic injection of BTX, as well as on patient's satisfaction with this therapy. Short‐term results are promising and comparable with those reported with standard pharmacological therapy.OBJECTIVE
To evaluate patient‐reported and objective outcomes after intraprostatic injection of OnabotulinumtoxinA (BTX‐A) in men with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).
PATIENTS AND METHODS
A prospective single‐armed cohort study was designed.
Patients diagnosed with LUTS due to BPH and unsatisfactory response to medical therapy, were recruited between November 2010 and July 2011.
Patients received transperineal injection of 200 U BTX‐A in the transition zone, under transrectal ultrasonographic guidance.
The outcome assessment was performed at 3 months and included a patient‐reported outcomes (PROs) questionnaire with questions on patient global impression of improvement (PGI‐I, 0–6 point scale), of satisfaction (PGI‐S, 0–5 point scale), and of efficacy (PGI‐E, 0–5 point scale).
RESULTS
Of 75 screened patients, 64 with a mean (sd) age of 63 (9.3) years were available for the outcome assessment.
Patients reported a mean reduction of 49% in International Prostate Symptom Score (IPSS), which decreased from 19.7 (7.7) to 10 (7.1) (P < 0.001), and a mean reduction of 44% in IPSS‐health‐related quality of life item score, from 4.17 (1.2) to 2.3 (1.6) (P < 0.001).
There was a 33% increase in maximum urinary flow rate (P < 0.001) and an 80% reduction in postvoid residual urine volume (P < 0.001).
In all, 36 (56%) patients had a subjective improvement in LUTS (PGI‐I ≥ 4), 43 (67%) reported satisfaction with the treatment (PGI‐S ≥ 3), and 44 (68%) judged the treatment as effective (PGI‐E ≥ 3). In all, 50 (79%) patients would repeat the same treatment under the same circumstances, while 54 (84%) would recommend the treatment to another person with the same diagnosis.
There was a statistically significant positive correlation between patients' satisfaction and both baseline IPSS (ρ 0.441, P < 0.001) and reduction rate of the IPSS (ρ 0.850, P < 0.001).
CONCLUSIONS
Intraprostatic injection of BTX‐A in men with LUTS due to BPH provides clinically significant short‐term subjective and objective benefit.
Increasing severity of baseline LUTS appears moderately associated with the patient‐perceived benefit from the treatment.
Although the non‐randomised design and short‐term assessment limit the level of evidence of our study, intraprostatic BTX‐A seems a promising, safe and minimally invasive option for patients with BPH with unsatisfactory response to standard drug therapy.