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


Emilio Sacco, Urologia, Policlinico ‘Agostino Gemelli’, Largo Gemelli 8, 00168 Roma, Italy. e-mail:


Study Type – Therapy (prospective cohort)

Level of Evidence 3a

What'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.


  • • 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).


  • • 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).


  • • 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).


  • • 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.