Intradetrusor onabotulinumtoxinA injections are significantly more efficacious than oral oxybutynin for treatment of neurogenic detrusor overactivity: results of a randomized, controlled, 24-week trial.

OBJECTIVE: To prospectively compare the results of intradetrusor onabotulinumtoxinA injections and oral oxybutynin for urinary continence, urodynamic parameters and quality of life in patients with neurogenic detrusor overactivity due to spinal cord injury. METHODS: Adult patients under intermittent catheterization were randomized 1:1 to receive one injection of onabotulinumtoxinA 300U or oxybutynin 5mg, per oris, three times/day. Primary study endpoint was change in urinary incontinence episodes/24 hours and secondary study endpoints were maximum cystometric capacity, maximum detrusor pressure, bladder compliance and quality of life before randomization and at week 24. RESULTS: Sixty-eight patients participated in the trial. Significant improvements in urinary incontinence per 24 hours, all investigated urodynamic parameters and quality of life were observed in both groups. Compared with oral oxybutynin, onabotulinumtoxinA was significantly more efficacious for all parameters investigated. Non-response to treatment was higher for oral oxybutynin (23.5%) than onabotulinumtoxinA (11.8%). Dry mouth was the most common adverse in patients with oral oxybutynin (72%) and transient macroscopic hematuria in patients with onabotulinumtoxinA (28%). Only one patient with oral oxybutynin dropped out the study because of adverse effects. CONCLUSION: The comparison of the two study drugs showed that onabotulinumtoxinA was significantly more efficacious than oral oxybutynin with regard to continence, urodynamic parameters and quality of life. Clinicaltrials.gov: NCT:01477736.

Treatment of intrinsic sphincter deficiency using the Macroplastique Implantation System: two-year follow-up.

PURPOSE: To evaluate the 24-month outcome of the Macroplastique Implantation System (MIS) for the treatment of stress urinary incontinence (SUI) using objective and subjective measures, including quality-of-life (QoL) impact. PATIENTS AND METHODS: Twenty-one consecutive women with a mean age of 47.4 years and a mean body mass index 26.16 kg/m(2) having urodynamically diagnosed intrinsic sphincter deficiency (ISD) were enrolled. Patients were assessed preoperatively and postoperatively by physical examination, Stamey grading of incontinence, pad usage, pad weight test, and urodynamic measurements. Quality of life was assessed by the King's Health Questionnaire. Patients underwent transurethral injection of the MIS under local anesthesia on an outpatient basis. The mean volume injected was 6.3 mL. The data presented are based on 24-month followup from the last injection, and the patients were considered their own controls. RESULTS: Patient QoL improved in all domains. Ten patients (47%) considered themselves cured; three (14.3%) thought they were improved, and eight (38.1%) believed the procedure had failed. According to the subjective surgeon Stamey grading, 8 patients (38.1%) were considered cured, 5 (23.8%) improved, and 8 (38.1%) failed. Daily pad usage was reduced from a mean of 4.38 to 1.47. According to the pad weight test, 12 patients (57.1%) were dry and two (9.5%) improved, while in 7 (33.3%), MIS failed. Urodynamic testing demonstrated 10 patients (50%) dry and 5 (25%) improved. CONCLUSION: The MIS proved to have an outcome acceptable to patients and surgeons at 24-month followup. The procedure can be performed easily under local anesthesia.

Intradetrusor onabotulinumtoxinA injections are significantly more efficacious than oral oxybutynin for treatment of neurogenic detrusor overactivity: results of a randomized, controlled, 24-week trial / Injeções intradetrusoras de onabotulinumtoxinA são significativamente mais eficazes que oxibutinina oral para tratamento da hiperatividade detrusora neurogênica: resultados de estudo randomizado e controlado de 24 semanas

ABSTRACT Objective To prospectively compare the results of intradetrusor onabotulinumtoxinA injections and oral oxybutynin for urinary continence, urodynamic parameters and quality of life in patients with neurogenic detrusor overactivity due to spinal cord injury. Methods Adult patients under intermittent catheterization were randomized 1:1 to receive one injection of onabotulinumtoxinA 300U or oxybutynin 5mg, per oris, three times/day. Primary study endpoint was change in urinary incontinence episodes/24 hours and secondary study endpoints were maximum cystometric capacity, maximum detrusor pressure, bladder compliance and quality of life before randomization and at week 24. Results Sixty-eight patients participated in the trial. Significant improvements in urinary incontinence per 24 hours, all investigated urodynamic parameters and quality of life were observed in both groups. Compared with oral oxybutynin, onabotulinumtoxinA was significantly more efficacious for all parameters investigated. Non-response to treatment was higher for oral oxybutynin (23.5%) than onabotulinumtoxinA (11.8%). Dry mouth was the most common adverse in patients with oral oxybutynin (72%) and transient macroscopic hematuria in patients with onabotulinumtoxinA (28%). Only one patient with oral oxybutynin dropped out the study because of adverse effects. Conclusion The comparison of the two study drugs showed that onabotulinumtoxinA was significantly more efficacious than oral oxybutynin with regard to continence, urodynamic parameters and quality of life. Clinicaltrials.gov: NCT:01477736.

RESUMO Objetivo Comparar prospectivamente os resultados de injeções intradetrusoras de onabotulinumtoxinA e oxibutinina oral em pacientes com hiperatividade neurogênica do detrusor devido à lesão da medula espinhal, para avaliar a continência urinária, os parâmetros urodinâmicos e a qualidade de vida. Métodos Pacientes adultos em cateterismo intermitente foram randomizados 1:1 para tratamento com uma injeção de onabotulinumtoxinA 300U ou oxibutinina 5mg via oral, três vezes por dia. O desfecho primário foi alteração nos episódios de incontinência urinária em 24 horas, e os secundários foram capacidade cistométrica máxima, pressão máxima do detrusor, complacência vesical e qualidade de vida antes da randomização e na 24ª semana. Resultados Participaram do estudo 68 pacientes. Observou-se melhora significativa na incontinência urinária por 24 horas em todos os parâmetros urodinâmicos investigados e na qualidade de vida em ambos os grupos. Em comparação com a oxibutinina oral, a onabotulinumtoxinA foi significativamente mais eficaz para todos os parâmetros investigados. A falha no tratamento foi maior para oxibutinina oral (23,5%) em comparação com onabotulinumtoxinA (11,8%). A boca seca foi o evento adverso mais comum em pacientes tratados com oxibutinina oral (72%), e a hematúria macroscópica transitória naqueles tratados com onabotulinumtoxinA (28%). Apenas um paciente tratado com oxibutinina oral interrompeu o estudo por conta dos efeitos adversos. Conclusão A comparação dos dois fármacos do estudo mostrou que onabotulinumtoxinA foi significativamente mais eficaz que oxibutinina oral em relação a continência, parâmetros urodinâmicos e qualidade de vida. Clinicaltrials.gov: NCT:01477736.

Macroplastique implantation system for the treatment of female stress urinary incontinence.

PURPOSE: We evaluated the 12-month followup outcome of the Macroplastique (Uroplasty, Minneapolis, Minnesota) implantation system for the treatment of stress urinary incontinence caused by intrinsic sphincter deficiency using objective and subjective measures, including quality of life impact. MATERIALS AND METHODS: A total of 21 consecutive women with a mean age of 47.4 years and a mean body mass index of 25.65 kg./m.2 in whom intrinsic sphincter deficiency was urodynamically diagnosed were enrolled in the study. Patients were preoperatively assessed by physical examination, quality of life questionnaire, Stamey grading of incontinence, pad use, pad weight test and urodynamic testing. Patients underwent periurethral injection under local anesthesia with the Macroplastique implantation system. The mean volume of silicone elastomers injected was 6.3 ml. RESULTS: As assessed by the King health questionnaire, patient quality of life improved in all domains and in most lower urinary tract symptoms. Patient satisfaction and subjective surgeon evaluation were assessed by Stamey incontinence grading. From patient point of view 12 (57.1%) considered themselves cured, 4 (19%) were improved and 5 (23.8%) had failure. According to subjective surgeon grading 8 patients (38.1%) were considered cured 6 (28.6%) were improved and 7 (33.3%) had failure. Pad use decreased from a mean of 4.38 to 1.29 units daily. According to the pad weight test 13 patients (62%) were dry, 4 (19%) were improved and 4 (19%) had failure. Urodynamic testing demonstrated that 8 patients (40%) were dry and 1 (5%) was improved. CONCLUSIONS: The Macroplastique implantation system proved to have an acceptable outcome for patient and surgeon. The procedure can be done with local anesthesia and without cystoscopic guidance.