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

Sponsor

APOGEPHA Arzneimittel GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT01530620

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Neurogenic Urinary Bladder Disorder Urinary Bladder, Neurogenic Bladder Disorder, Neurogenic Urinary Bladder Disorder, Neurogenic Neurogenic Bladder Disorder Urinary Bladder Neurogenic Dysfunction Urologic Diseases Overactive Detrusor Function Urinary Incontinence	Drug: Propiverine hydrochloride ER (extended release) Drug: Propiverine hydrochloride IR (immediate release)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Dec 1, 2004

Actual Primary Completion Date :

Jun 1, 2005

Actual Study Completion Date :

Jul 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Propiverine hydrochloride ER 45 mg	Drug: Propiverine hydrochloride ER (extended release) 45 mg capsule (1x1/d) Other Names: Mictonorm UNO 45 Detrunorm XL 45
Active Comparator: Propiverine hydrochloride IR 15 mg	Drug: Propiverine hydrochloride IR (immediate release) 15 mg tablet (3x1/d) Other Names: Mictonorm Detrunorm

Arm

Intervention/Treatment

Experimental: Propiverine hydrochloride ER

45 mg

Drug: Propiverine hydrochloride ER (extended release)

45 mg capsule (1x1/d)

Other Names:

Mictonorm UNO 45

Detrunorm XL 45

Active Comparator: Propiverine hydrochloride IR

15 mg

Drug: Propiverine hydrochloride IR (immediate release)

15 mg tablet (3x1/d)

Other Names:

Mictonorm

Detrunorm

Outcome Measures

Primary Outcome Measures

Reflex volume (cystometry) [three weeks]
Change in reflex volume compared to baseline and compared between the two treatment arms

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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