Rui Almeida Pinto1, Daniel Costa2, Afonso Morgado3, Pedro Pereira2, Ana Charrua4, João Silva5, Francisco Cruz5. 1. Instituto de Investigação e Inovação em Saúde (i3S), Porto, Portugal. Electronic address: ruipinto@mac.com. 2. Department of Urology, Hospital de São João, Porto, Portugal. 3. Department of Urology, Hospital de São João, Porto, Portugal; Faculty of Medicine of Porto, Porto, Portugal. 4. Faculty of Medicine of Porto, Porto, Portugal. 5. Instituto de Investigação e Inovação em Saúde (i3S), Porto, Portugal.
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.
RCT Entities:
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.
Authors: T Bschleipfer; R Doggweiler; D Schultz-Lampel; J de Jong; A Gonsior; J Hensen; E Heßdörfer; B T Kaftan; A Kuhn; U Kunzendorf; A Lampel; A Landmesser; A Loch; O Moormann; B Müller; J Neuhaus; A Reich; R Roth; S Schumacher; R Stratmeyer; W Vahlensieck; A Wördehoff; B Münder-Hensen Journal: Urologe A Date: 2019-11 Impact factor: 0.639
Authors: Alexandra Dubinskaya; Lauren N Tholemeier; Tyler Erickson; Amanda M De Hoedt; Kamil E Barbour; Jayoung Kim; Stephen J Freedland; Jennifer T Anger Journal: Female Pelvic Med Reconstr Surg Date: 2022-03-01 Impact factor: 2.091
Authors: Hadi Mostafaei; Sandra Jilch; Greta Lisa Carlin; Keiichiro Mori; Fahad Quhal; Benjamin Pradere; Ekaterina Laukhtina; Victor M Schuettfort; Abdulmajeed Aydh; Reza Sari Motlagh; Claus G Roehrborn; Shahrokh F Shariat; Sakineh Hajebrahimi Journal: Nat Rev Urol Date: 2021-12-23 Impact factor: 14.432