Efficacy and Tolerability of Propiverine Hydrochloride in Patients With Neurogenic Detrusor Overactivity

Overview

The purpose of this clinical study is to compare efficacy and safety of propiverine hydrochloride extended and immediate release formulations in patients suffering from neurogenic detrusor overactivity.

Full Title of Study: “Efficacy and Tolerability of Propiverine Hydrochloride Extended Release (ER) Compared to Immediate Release (IR) in Patients With Neurogenic Detrusor Overactivity. A Randomized, Double Blind, Parallel Group, Multicenter Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2005

Interventions

  • Drug: Propiverine hydrochloride ER (extended release)
    • 45 mg capsule (1×1/d)
  • Drug: Propiverine hydrochloride IR (immediate release)
    • 15 mg tablet (3×1/d)

Arms, Groups and Cohorts

  • Experimental: Propiverine hydrochloride ER
    • 45 mg
  • Active Comparator: Propiverine hydrochloride IR
    • 15 mg

Clinical Trial Outcome Measures

Primary Measures

  • Reflex volume (cystometry)
    • Time Frame: three weeks
    • Change in reflex volume compared to baseline and compared between the two treatment arms

Secondary Measures

  • Leak point pressure
    • Time Frame: three weeks
    • Change in LPP compared to baseline and compared between the two treatment arms
  • Leak point volume
    • Time Frame: three weeks
    • Change in LPV compared to baseline and compared between the two treatment arms
  • Maximum detrusor pressure
    • Time Frame: three weeks
    • Change in maximum p det compared to baseline and compared between the two treatment arms
  • Maximum cystometric capacity
    • Time Frame: three weeks
    • Change in maximum cystometric capacity compared to baseline and compared between the two treatment arms
  • Bladder compliance
    • Time Frame: three weeks
    • Change in compliance compared to baseline and compared between the two treatment arms
  • Change in number of incontinence episodes
    • Time Frame: three weeks
    • Change of incontinence episodes compared to baseline and compared between the two treatment arms
  • State of Well-Being Questionnaire
    • Time Frame: three weeks
    • Change of well-beeing compared to baseline and compared between the two treatment arms
  • Post void residual volume
    • Time Frame: three weeks
    • Change in PVR compared to baseline and compared between the two treatment arms
  • Incidence and severity of adverse events
    • Time Frame: three weeks
    • occurrences and intensity of adverse events or withdrawals over the whole treatment period

Participating in This Clinical Trial

Inclusion Criteria

  • Male or female Caucasian patients aged ≥18 and ≤70 years – Voluntarily signed informed consent – Neurogenic detrusor overactivity with occurrence of reflex detrusor contractions – Reflex volume of ≤250 mL – Intact reflex arcs in the area of segments S2-S4 Exclusion Criteria:

  • Patients suffering from multiple sclerosis under unstable conditions – Augmented reflex bladder – Patients with increased residual urine (≥20 % of the maximum bladder capacity), in whom catheterization is not possible – Acute urinary tract infection – Electrostimulation therapy (within 4 weeks propir to Visit 1) – Anomalies of the lower genitourinary tract (e.g. ectopic ureters, fistulas, urethral stenosis) – Radiation bladder, interstitial cystitis, bladder calculi, bladder carcinoma – Surgery of the lower genitourinary tract within the last 6 months (e.g. prostatectomy, hysterectomy, tumor surgery) – Pre-existing medical contraindications for anticholinergics – Cardiac insufficiency (NYHA stage III/ IV) – Therapy with botulinum toxin within the last 12 months – Evidence of severe renal, hepatic or metabolic disorders – History of drug or alcohol abuse – Concomitant medication known to have a potential to interfere with the trial medication – Known hypersensitivity to Propiverine hydrochloride or excipients contained in the trial medication, respectively – Pregnant or breast-feeding women, or women of childbearing potential without using any reliable contraceptive method – Patients with impaired co-operation or who are unable to understand the nature, scope and possible consequences of the study

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • APOGEPHA Arzneimittel GmbH
  • Provider of Information About this Clinical Study
    • Sponsor

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