• 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
PATIENTS AND METHODS
• A prospective single-armed cohort study
• 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
• 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
• Increasing severity of baseline LUTS
appears moderately associated with the
patient-perceived benefit from the
• 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.
- BOTULINUM TOXIN
- LOWER URINARY TRACT SYMPTOMS