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OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive bladder and urinary incontinence: a randomised, double-blind, placebo-controlled trial.
Eur Urol 2013; 64(2):249-56EU

Abstract

BACKGROUND

Overactive bladder (OAB) syndrome with urinary incontinence (UI) is prevalent in the population and impairs health-related quality of life (HRQOL).

OBJECTIVE

To assess the impact on efficacy, safety, and HRQOL of onabotulinumtoxinA (BOTOX(®), Allergan, Inc.) treatment in patients with OAB with UI.

DESIGN, SETTING, AND PARTICIPANTS

This pivotal, multicentre, double-blind, randomised, placebo-controlled, phase 3 study enrolled patients with idiopathic OAB with ≥ 3 urgency UI episodes over 3 d and ≥ 8 micturitions per day who were inadequately managed by anticholinergics.

INTERVENTION

OnabotulinumtoxinA at a 100U dose (n=277) or placebo (n=271), administered as 20 intradetrusor injections of 0.5 ml.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

Co-primary end points were change from baseline in the number of UI episodes per day and proportion of patients reporting positive treatment response on the treatment benefit scale (TBS) at week 12. Additional end points included other OAB symptoms (episodes of urinary urgency incontinence, micturition, urgency, and nocturia) and HRQOL (Incontinence Quality of Life [I-QOL], King's Health Questionnaire [KHQ]). Safety assessments included adverse events (AEs), postvoid residual (PVR) urine volume, and initiation of clean intermittent catheterisation (CIC).

RESULTS AND LIMITATIONS

OnabotulinumtoxinA significantly decreased UI episodes per day at week 12 (-2.95 for onabotulinumtoxinA versus -1.03 for placebo; p<0.001). Reductions from baseline in all other OAB symptoms were also significantly greater following onabotulinumtoxinA compared with placebo (p ≤ 0.01). Patients perceived a significant improvement in their condition, as measured by patients with a positive treatment response on the TBS (62.8% for onabotulinumtoxinA versus 26.8% for placebo; p<0.001). Clinically meaningful improvements from baseline in all I-QOL and KHQ multi-item domains (p<0.001 versus placebo) indicated positive impact on HRQOL. AEs were mainly localised to the urinary tract. Mean PVR was higher in the onabotulinumtoxinA group (46.9 ml versus 10.1 ml at week 2; p<0.001); 6.9% of onabotulinumtoxinA patients versus 0.7% of placebo patients initiated CIC.

CONCLUSIONS

OnabotulinumtoxinA 100 U was well tolerated and demonstrated significant and clinically relevant improvements in all OAB symptoms, patient-reported benefit, and HRQOL in patients inadequately managed by anticholinergics.

TRIAL REGISTRATION

ClinicalTrials.gov: NCT00910520.

Authors+Show Affiliations

Royal Hallamshire Hospital, Sheffield, UK. c.r.chapple@shef.ac.ukNo 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)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23608668

Citation

Chapple, Christopher, et al. "OnabotulinumtoxinA 100 U Significantly Improves All Idiopathic Overactive Bladder Symptoms and Quality of Life in Patients With Overactive Bladder and Urinary Incontinence: a Randomised, Double-blind, Placebo-controlled Trial." European Urology, vol. 64, no. 2, 2013, pp. 249-56.
Chapple C, Sievert KD, MacDiarmid S, et al. OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive bladder and urinary incontinence: a randomised, double-blind, placebo-controlled trial. Eur Urol. 2013;64(2):249-56.
Chapple, C., Sievert, K. D., MacDiarmid, S., Khullar, V., Radziszewski, P., Nardo, C., ... Haag-Molkenteller, C. (2013). OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive bladder and urinary incontinence: a randomised, double-blind, placebo-controlled trial. European Urology, 64(2), pp. 249-56. doi:10.1016/j.eururo.2013.04.001.
Chapple C, et al. OnabotulinumtoxinA 100 U Significantly Improves All Idiopathic Overactive Bladder Symptoms and Quality of Life in Patients With Overactive Bladder and Urinary Incontinence: a Randomised, Double-blind, Placebo-controlled Trial. Eur Urol. 2013;64(2):249-56. PubMed PMID: 23608668.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive bladder and urinary incontinence: a randomised, double-blind, placebo-controlled trial. AU - Chapple,Christopher, AU - Sievert,Karl-Dietrich, AU - MacDiarmid,Scott, AU - Khullar,Vik, AU - Radziszewski,Piotr, AU - Nardo,Christopher, AU - Thompson,Catherine, AU - Zhou,Jihao, AU - Haag-Molkenteller,Cornelia, Y1 - 2013/04/10/ PY - 2013/03/06/received PY - 2013/04/01/accepted PY - 2013/4/24/entrez PY - 2013/4/24/pubmed PY - 2014/2/8/medline KW - Botulinum toxin KW - OnabotulinumtoxinA KW - Overactive bladder KW - Urinary incontinence SP - 249 EP - 56 JF - European urology JO - Eur. Urol. VL - 64 IS - 2 N2 - BACKGROUND: Overactive bladder (OAB) syndrome with urinary incontinence (UI) is prevalent in the population and impairs health-related quality of life (HRQOL). OBJECTIVE: To assess the impact on efficacy, safety, and HRQOL of onabotulinumtoxinA (BOTOX(®), Allergan, Inc.) treatment in patients with OAB with UI. DESIGN, SETTING, AND PARTICIPANTS: This pivotal, multicentre, double-blind, randomised, placebo-controlled, phase 3 study enrolled patients with idiopathic OAB with ≥ 3 urgency UI episodes over 3 d and ≥ 8 micturitions per day who were inadequately managed by anticholinergics. INTERVENTION: OnabotulinumtoxinA at a 100U dose (n=277) or placebo (n=271), administered as 20 intradetrusor injections of 0.5 ml. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Co-primary end points were change from baseline in the number of UI episodes per day and proportion of patients reporting positive treatment response on the treatment benefit scale (TBS) at week 12. Additional end points included other OAB symptoms (episodes of urinary urgency incontinence, micturition, urgency, and nocturia) and HRQOL (Incontinence Quality of Life [I-QOL], King's Health Questionnaire [KHQ]). Safety assessments included adverse events (AEs), postvoid residual (PVR) urine volume, and initiation of clean intermittent catheterisation (CIC). RESULTS AND LIMITATIONS: OnabotulinumtoxinA significantly decreased UI episodes per day at week 12 (-2.95 for onabotulinumtoxinA versus -1.03 for placebo; p<0.001). Reductions from baseline in all other OAB symptoms were also significantly greater following onabotulinumtoxinA compared with placebo (p ≤ 0.01). Patients perceived a significant improvement in their condition, as measured by patients with a positive treatment response on the TBS (62.8% for onabotulinumtoxinA versus 26.8% for placebo; p<0.001). Clinically meaningful improvements from baseline in all I-QOL and KHQ multi-item domains (p<0.001 versus placebo) indicated positive impact on HRQOL. AEs were mainly localised to the urinary tract. Mean PVR was higher in the onabotulinumtoxinA group (46.9 ml versus 10.1 ml at week 2; p<0.001); 6.9% of onabotulinumtoxinA patients versus 0.7% of placebo patients initiated CIC. CONCLUSIONS: OnabotulinumtoxinA 100 U was well tolerated and demonstrated significant and clinically relevant improvements in all OAB symptoms, patient-reported benefit, and HRQOL in patients inadequately managed by anticholinergics. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00910520. SN - 1873-7560 UR - https://www.unboundmedicine.com/medline/citation/23608668/OnabotulinumtoxinA_100_U_significantly_improves_all_idiopathic_overactive_bladder_symptoms_and_quality_of_life_in_patients_with_overactive_bladder_and_urinary_incontinence:_a_randomised_double_blind_placebo_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0302-2838(13)00355-2 DB - PRIME DP - Unbound Medicine ER -