Intratrigonal OnabotulinumtoxinA Improves Bladder Symptoms and Quality of Life in Patients with Bladder Pain Syndrome/Interstitial Cystitis: A Pilot, Single Center, Randomized, Double-Blind, Placebo Controlled Trial
2017; Lippincott Williams & Wilkins; Volume: 199; Issue: 4 Linguagem: Inglês
10.1016/j.juro.2017.10.018
ISSN1527-3792
AutoresRui Pinto, Daniel L. Costa, Afonso Morgado, Pedro Pereira, Ana Charrua, João Silva, Francisco Cruz,
Tópico(s)Sexual function and dysfunction studies
ResumoNo AccessJournal of UrologyAdult Urology1 Apr 2018Intratrigonal OnabotulinumtoxinA Improves Bladder Symptoms and Quality of Life in Patients with Bladder Pain Syndrome/Interstitial Cystitis: A Pilot, Single Center, Randomized, Double-Blind, Placebo Controlled Trial Rui Almeida Pinto, Daniel Costa, Afonso Morgado, Pedro Pereira, Ana Charrua, João Silva, and Francisco Cruz Rui Almeida PintoRui Almeida Pinto Instituto de Investigação e Inovação em Saúde (i3S), Porto, Portugal , Daniel CostaDaniel Costa Department of Urology, Hospital de São João, Porto, Portugal , Afonso MorgadoAfonso Morgado Department of Urology, Hospital de São João, Porto, Portugal Faculty of Medicine of Porto, Porto, Portugal , Pedro PereiraPedro Pereira Department of Urology, Hospital de São João, Porto, Portugal , Ana CharruaAna Charrua Faculty of Medicine of Porto, Porto, Portugal , João SilvaJoão Silva Instituto de Investigação e Inovação em Saúde (i3S), Porto, Portugal , and Francisco CruzFrancisco Cruz Instituto de Investigação e Inovação em Saúde (i3S), Porto, Portugal View All Author Informationhttps://doi.org/10.1016/j.juro.2017.10.018AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We compared the efficacy and safety of trigonal injections of onabotulinumtoxinA and saline in patients with bladder pain syndrome/interstitial cystitis. Materials and Methods: This phase II study enrolled women who had had bladder pain syndrome/interstitial cystitis for more than 6 months and pain for 4 months or longer on a visual analogue scale of 0 to 10, which were refractory to common treatment. OnabotulinumtoxinA 100 U in 10 or saline as placebo in 9 was administered as 10 trigonal injections of 1 ml. The primary study end point was the change from baseline pain intensity reported at week 12. Additional end points included O'Leary-Sant scores, micturition frequency, quality of life at week 4, 8 and 12, and the treatment benefit scale at week 12. Safety assessments included urinary tract infection, post-void residual urine and the initiation of clean intermittent catheterization. Results: At week 12 onabotulinumtoxinA had significantly reduced pain compared with saline (mean ± SD –3.8 ± 2.5 vs –1.6 ± 2.1, p <0.05). The proportion of patients who achieved a 50% or greater reduction in the pain visual analog scale was 60% for onabotulinumtoxinA vs 22% for placebo. OnabotulinumtoxinA significantly improved O'Leary-Sant scores and quality of life over placebo at weeks 4, 8 and 12. Important numerical reductions in voiding frequency were also observed with the toxin. OnabotulinumtoxinA was well tolerated. Urinary tract infections developed in 3 patients who received onabotulinumtoxinA vs 2 who received saline. Mean post-void residual urine at week 12 was 5 ± 13 ml for onabotulinumtoxinA vs 0 ml with saline. This study had the limitations inherent to a single center trial with a small number of patients enrolled. Conclusions: OnabotulinumtoxinA 100 U caused significant and clinically relevant improvements in bladder pain and quality of life in patients with bladder pain syndrome/interstitial cystitis refractory to common therapy. It was also well tolerated. 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Google Scholar © 2018 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byClemens J, Erickson D, Varela N and Lai H (2022) Diagnosis and Treatment of Interstitial Cystitis/Bladder Pain SyndromeJournal of Urology, VOL. 208, NO. 1, (34-42), Online publication date: 1-Jul-2022.Smith J (2018) This Month in Adult UrologyJournal of Urology, VOL. 199, NO. 4, (863-864), Online publication date: 1-Apr-2018. Volume 199Issue 4April 2018Page: 998-1003 Advertisement Copyright & Permissions© 2018 by American Urological Association Education and Research, Inc.Keywordsquality of lifeinterstitialpelvic paincystitisfemaleurinary bladderMetricsAuthor Information Rui Almeida Pinto Instituto de Investigação e Inovação em Saúde (i3S), Porto, Portugal More articles by this author Daniel Costa Department of Urology, Hospital de São João, Porto, Portugal More articles by this author Afonso Morgado Department of Urology, Hospital de São João, Porto, Portugal Faculty of Medicine of Porto, Porto, Portugal More articles by this author Pedro Pereira Department of Urology, Hospital de São João, Porto, Portugal More articles by this author Ana Charrua Faculty of Medicine of Porto, Porto, Portugal More articles by this author João Silva Instituto de Investigação e Inovação em Saúde (i3S), Porto, Portugal More articles by this author Francisco Cruz Instituto de Investigação e Inovação em Saúde (i3S), Porto, Portugal More articles by this author Expand All Advertisement PDF downloadLoading ...
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