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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01530620
• Other study ID #: 8405010
• Status: Completed
• Phase: Phase 3
• First received: February 2, 2012
• Last updated: February 9, 2012
• Start date: December 2004
• Est. completion date: July 2006

Study information

• Verified date: February 2012
• Source: APOGEPHA Arzneimittel GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesAustria: Agency for Health and Food SafetyRomania: National Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 2006
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Disorder, Neurogenic
• Disease
• Neurogenic Bladder Disorder
• Neurogenic Urinary Bladder Disorder
• Overactive Detrusor Function
• Urinary Bladder Diseases
• Urinary Bladder Disorder, Neurogenic
• Urinary Bladder Neurogenic Dysfunction
• Urinary Bladder, Neurogenic
• Urinary Bladder, Overactive
• Urinary Incontinence
• Urologic Diseases

Intervention

Drug:
• Propiverine hydrochloride ER (extended release)
45 mg capsule (1x1/d)
• Propiverine hydrochloride IR (immediate release)
15 mg tablet (3x1/d)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
APOGEPHA Arzneimittel GmbH

Countries where clinical trial is conducted

Austria,  Germany,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reflex volume (cystometry)	Change in reflex volume compared to baseline and compared between the two treatment arms	three weeks	No
Secondary	Leak point pressure	Change in LPP compared to baseline and compared between the two treatment arms	three weeks	No
Secondary	Leak point volume	Change in LPV compared to baseline and compared between the two treatment arms	three weeks	No
Secondary	Maximum detrusor pressure	Change in maximum p det compared to baseline and compared between the two treatment arms	three weeks	No
Secondary	Maximum cystometric capacity	Change in maximum cystometric capacity compared to baseline and compared between the two treatment arms	three weeks	No
Secondary	Bladder compliance	Change in compliance compared to baseline and compared between the two treatment arms	three weeks	No
Secondary	Change in number of incontinence episodes	Change of incontinence episodes compared to baseline and compared between the two treatment arms	three weeks	No
Secondary	State of Well-Being Questionnaire	Change of well-beeing compared to baseline and compared between the two treatment arms	three weeks	No
Secondary	Post void residual volume	Change in PVR compared to baseline and compared between the two treatment arms	three weeks	Yes
Secondary	Incidence and severity of adverse events	occurrences and intensity of adverse events or withdrawals over the whole treatment period	three weeks	Yes