Helmut Madersbacher

Randomized, Double-Blind, Multicenter Trial on Treatment of Frequency, Urgency and Incontinence Related to Detrusor Hyperactivity: Oxybutynin versus Propantheline versus Placebo

Clinical efficacy and adverse effects of oxybutynin and propantheline in the treatment of symptoms related to detrusor hyperactivity were studied in a randomized, controlled, double-blind multicenter trial. Of 169 patients entered into the study 154 were evaluable for statistical analysis. Mean grade of improvement (visual analogue scale) was significantly higher with oxybutynin (58.2%) versus propantheline (44.7%) and placebo (43.4%). Mean bladder volume at first involuntary cystometric contraction was significantly increased with oxybutynin (+57.0 ml.) versus placebo (-9.7 ml.). Mean maximum cystometric bladder capacity was also significantly increased with oxybutynin (+80.1 ml.) versus placebo (+22.5 ml.). Rate of inquired possible adverse effects was significantly higher for oxybutynin (63%) versus propantheline (44%) and placebo (33%). However, only 5 patients dropped out of the study because of adverse effects (oxybutynin 2 and propantheline 3). No serious or lasting adverse effects were encountered with dryness of the mouth being the major complaint. Oxybutynin has statistically significant effects on subjective symptoms and objective urodynamic parameters in patients with detrusor hyperactivity compared to propantheline.

The Standardization of Terminology in Neurogenic Lower Urinary Tract Dysfunction With Suggestions for Diagnostic Procedures

1Department of Urology, Berufsgenossenschaftliche Unfallklinik Murnau, Murnau, Germany 2Department of Urology, University of Essen Medical School, Essen, Germany 3Komaki Shimin Hospital, Johbushi, Komaki, Japan 4Urodynamics Laboratory, Berufsgenossenschaftliche Unfallklinik Murnau, Murnau, Germany 5University Hospital Innsbruck, Innsbruck, Austria 6Department of Urology, The Prince Henry Hospital, Little Bay, Sidney, Australia 7Geneva, Switzerland 8Department of Urology, University Hospital Antwerp, Antwerp, Belgium

Efficacy, tolerability and safety profile of propiverine in the treatment of the overactive bladder (non-neurogenic and neurogenic)

Abstract Propiverine hydrochloride (propiverine) is a compound that has neurotropic and musculotropic effects on the urinary bladder smooth muscle. Controlled clinical trials have shown its effectiveness in treating detrusor hyperreflexia and in treating patients with symptoms of an overactive bladder; this is true not only for adults but in children and the elderly as well. European and Japanese studies have also documented that propiverine is well tolerated. It is better tolerated than oxybutynin (particularly in regard to frequency and severity of dryness of the mouth). In several Japanese studies authors demonstrated that propiverine is well tolerated on a long-term basis. Voigt reported an adverse event incidence rate of 13% in a follow-up investigation during 10 years of treatment. A post-marketing drug surveillance consisting of 4390 patients provided additional data concerning efficacy and safety of propiverine. It is one of the few drugs recommended for the treatment of detrusor overactivity by the Committee on Pharmacological Treatment during the First International Consultation on Incontinence.

Efficacy and safety of propiverine in SCI-patients suffering from detrusor hyperreflexia : A double-blind, placebo-controlled clinical trial

Aims of the study: The aim of this double-blind, randomised, prospective, multicentre trial was to evaluate the efficacy of propiverine in patients suffering from detrusor hyperreflexia caused by spinal cord injury in comparison to placebo. Study design: The treatment period of 14 days comprised visits at baseline (V1) and after 14 days treatment (V2). Fifteen mg propiverine t.i.d. or placebo t.i.d. were administered as medication. The following efficacy parameters were adopted: the urodynamic parameters maximal cystometric bladder capacity, bladder volume on onset of the first as well as duration and amplitude of the maximum detrusor contraction, bladder compliance and residual urine, and subjective assessment of efficacy by physicians. For the evaluation of the safety of propiverine the incidence rate of adverse events by directly questioning as well as laboratory parameters were investigated. For biometrical evaluation t-test for independent groups was applied. Results: One hundred and thirteen patients were investigated. The maximal cystometric bladder capacity increased significantly in the propiverine group, on average by 104 ml (V1: 262±132 ml. V2: 366±143 ml, P<0.001). The changes in bladder capacity during the first contraction and the maximum detrusor contraction in the verum group were both statistically significant. The bladder compliance documented a more pronounced increase under propiverine in comparison to placebo. Residual urine increased by 37±71 ml in the propiverine group, significantly more than in the placebo group (P=0.01). Sixty-three per cent of the patients expressed subjectively an improvement under propiverine in comparison with 23% of the placebo group. Expected anticholinergic adverse events occurred: dryness of the mouth (37% in the verum and 8% in the placebo group), accommodation disorders (28% and 2% respectively). Nausea, constipation, headache, dizziness, tiredness and palpitations were reported in almost comparable incidence rates between 3 and 13% in both treatment groups. Eight drop-outs were registered in the propiverine group (five due to adverse events) and three in the placebo group (one due to adverse events). The laboratory parameters revealed no changes. Conclusion: Propiverine proved its efficacy in detrusor hyperreflexia with regard to the urodynamic parameters of the maximal cystometric bladder capacity and detrusor contractility. Anticholinergic adverse events such as dryness of the mouth and accommodation disorders were considered being tolerable. The increase in residual urine reflects the therapeutically desired effect of detrusor relaxation because the majority of patients normally practise intermittent catheterisation for bladder emptying.

Safety of prolonged sacral neuromodulation tined lead testing.

ABSTRACT Objective: Prolonged sacral neuromodulation (SNM) testing is more reliable for accurate patient selection than the usual test period of 4–7 days. However, prolonged testing was suspected to result in a higher complication rate due to infection via the percutaneous passage of the extension wire. Therefore, we prospectively assessed the complications associated with prolonged tined lead testing. Patients and methods: A consecutive series of 44 patients who underwent prolonged tined lead testing for at least 14 days between May 2002 and April 2007 were evaluated. Complications during prolonged tined lead testing, during and after tined lead explantation and during follow-up after implantation of the implantable pulse generator (IPG) were registered prospectively. Results: Four patients suffered from urgency-frequency syndrome, 13 from urge incontinence, 18 from non-obstructive chronic urinary retention and nine from chronic pelvic pain syndrome. The median test phase was 30 days (interquartile range [IQR] 21–36). Thirty-two of the 44 patients (73%) had successful prolonged tined lead testing and 31 of these (97%) underwent the implantation of the IPG. The median follow-up of the IPG implanted patients was 31 months (IQR 20–41). The complication rate was 5% (2/44) during prolonged tined lead testing and 16% (5/31) during follow-up of the IPG implanted patients, respectively. None of the complications could be attributed to prolonged testing. No infections were observed during the study period. Conclusions: This prospective, observational non-randomised study suggests prolonged SNM tined lead testing is a safe procedure. Based on the low complication rate and the increased reliability for accurate patient selection, this method is proposed as a possible standard test procedure, subject to confirmation by further randomised, controlled clinical studies.

Neurologic urinary incontinence

This manuscript summarizes the work of Committee 10 on neurologic bladder and bowel of the International Consultation on Incontinence in 2008–2009. As the data are very large the outcome is presented in different manuscripts. This manuscript deals with neurologic urinary incontinence.

What are the causes and consequences of bladder overdistension?: ICI‐RS 2011

To report the outcome of the think tank on prolonged bladder overdistension from the 3rd ICI‐RS meeting.

Efficacy, tolerability and safety of propiverine hydrochloride in comparison to oxybutynin in children with urge incontinence due to overactive bladder: Results of a multicentre observational cohort study

Study Type – Therapy (observational cohort)
Level of Evidence 2b

GAG Layer Replenishment Therapy for Chronic Forms of Cystitis With Intravesical Glycosaminoglycans—A Review

Glycosaminoglycan (GAG) layer replenishment is a cornerstone in the therapy of interstitial cystitis (IC). During the last years intravesical GAG layer replenishment has proven to be an effective treatment for overactive bladder (OAB), radiation cystitis, and recurrent urinary tract infections (UTIs).

Propiverine vs oxybutynin for treating neurogenic detrusor overactivity in children and adolescents : results of a multicentre observational cohort study

To compare, in a retrospective observational cohort study, the efficacy, tolerability, safety and clinical effectiveness of propiverine and oxybutynin in children and adolescents with neurogenic detrusor overactivity (NDO).