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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.
BJU Int. 2012 Dec; 110(11 Pt C):E837-44.BI

Abstract

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.

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.

Authors+Show Affiliations

Urology Clinic, Agostino Gemelli Hospital, Catholic University Medical School, Rome, Italy. emilio.sacco@gmail.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

22712582

Citation

Sacco, Emilio, et al. "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." BJU International, vol. 110, no. 11 Pt C, 2012, pp. E837-44.
Sacco E, Bientinesi R, Marangi F, et al. 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. BJU Int. 2012;110(11 Pt C):E837-44.
Sacco, E., Bientinesi, R., Marangi, F., Totaro, A., D'Addessi, A., Racioppi, M., Pinto, F., Vittori, M., & Bassi, P. (2012). 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. BJU International, 110(11 Pt C), E837-44. https://doi.org/10.1111/j.1464-410X.2012.11288.x
Sacco E, et al. 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. BJU Int. 2012;110(11 Pt C):E837-44. PubMed PMID: 22712582.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Sacco,Emilio, AU - Bientinesi,Riccardo, AU - Marangi,Francesco, AU - Totaro,Angelo, AU - D'Addessi,Alessandro, AU - Racioppi,Marco, AU - Pinto,Francesco, AU - Vittori,Matteo, AU - Bassi,Pierfrancesco, Y1 - 2012/06/19/ PY - 2012/6/21/entrez PY - 2012/6/21/pubmed PY - 2013/2/6/medline SP - E837 EP - 44 JF - BJU international JO - BJU Int. VL - 110 IS - 11 Pt C N2 - UNLABELLED: 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. 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. SN - 1464-410X UR - https://www.unboundmedicine.com/medline/citation/22712582/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_ L2 - https://doi.org/10.1111/j.1464-410X.2012.11288.x DB - PRIME DP - Unbound Medicine ER -