Back to resultsEfficacy and Tolerability of Propiverine Hydrochloride in Patients With Neurogenic Detrusor Overactivity
Primary Purpose
Neurogenic Urinary Bladder Disorder, Urinary Bladder, Neurogenic, Bladder Disorder, Neurogenic
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Propiverine hydrochloride ER (extended release)
Propiverine hydrochloride IR (immediate release)
Sponsored by
About this trial
This is an interventional treatment trial for Neurogenic Urinary Bladder Disorder focused on measuring Antimuscarinics, Neurogenic bladder, Propiverine, Urodynamics
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Propiverine hydrochloride ER
Propiverine hydrochloride IR
Arm Description
45 mg
15 mg
Outcomes
Primary Outcome Measures
Reflex volume (cystometry)
Change in reflex volume compared to baseline and compared between the two treatment arms
Secondary Outcome Measures
Leak point pressure
Change in LPP compared to baseline and compared between the two treatment arms
Leak point volume
Change in LPV compared to baseline and compared between the two treatment arms
Maximum detrusor pressure
Change in maximum p det compared to baseline and compared between the two treatment arms
Maximum cystometric capacity
Change in maximum cystometric capacity compared to baseline and compared between the two treatment arms
Bladder compliance
Change in compliance compared to baseline and compared between the two treatment arms
Change in number of incontinence episodes
Change of incontinence episodes compared to baseline and compared between the two treatment arms
State of Well-Being Questionnaire
Change of well-beeing compared to baseline and compared between the two treatment arms
Post void residual volume
Change in PVR compared to baseline and compared between the two treatment arms
Incidence and severity of adverse events
occurrences and intensity of adverse events or withdrawals over the whole treatment period
Full Information
NCT ID
NCT01530620
First Posted
February 2, 2012
Last Updated
February 9, 2012
Sponsor
APOGEPHA Arzneimittel GmbH
1. Study Identification
Unique Protocol Identification Number
NCT01530620
Brief Title
Efficacy and Tolerability of Propiverine Hydrochloride in Patients With Neurogenic Detrusor Overactivity
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 Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
APOGEPHA Arzneimittel GmbH
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Antimuscarinics, Neurogenic bladder, Propiverine, Urodynamics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Propiverine hydrochloride ER
Arm Type
Experimental
Arm Description
45 mg
Arm Title
Propiverine hydrochloride IR
Arm Type
Active Comparator
Arm Description
15 mg
Intervention Type
Drug
Intervention Name(s)
Propiverine hydrochloride ER (extended release)
Other Intervention Name(s)
Mictonorm UNO 45, Detrunorm XL 45
Intervention Description
45 mg capsule (1x1/d)
Intervention Type
Drug
Intervention Name(s)
Propiverine hydrochloride IR (immediate release)
Other Intervention Name(s)
Mictonorm, Detrunorm
Intervention Description
15 mg tablet (3x1/d)
Primary Outcome Measure Information:
Title
Reflex volume (cystometry)
Description
Change in reflex volume compared to baseline and compared between the two treatment arms
Time Frame
three weeks
Secondary Outcome Measure Information:
Title
Leak point pressure
Description
Change in LPP compared to baseline and compared between the two treatment arms
Time Frame
three weeks
Title
Leak point volume
Description
Change in LPV compared to baseline and compared between the two treatment arms
Time Frame
three weeks
Title
Maximum detrusor pressure
Description
Change in maximum p det compared to baseline and compared between the two treatment arms
Time Frame
three weeks
Title
Maximum cystometric capacity
Description
Change in maximum cystometric capacity compared to baseline and compared between the two treatment arms
Time Frame
three weeks
Title
Bladder compliance
Description
Change in compliance compared to baseline and compared between the two treatment arms
Time Frame
three weeks
Title
Change in number of incontinence episodes
Description
Change of incontinence episodes compared to baseline and compared between the two treatment arms
Time Frame
three weeks
Title
State of Well-Being Questionnaire
Description
Change of well-beeing compared to baseline and compared between the two treatment arms
Time Frame
three weeks
Title
Post void residual volume
Description
Change in PVR compared to baseline and compared between the two treatment arms
Time Frame
three weeks
Title
Incidence and severity of adverse events
Description
occurrences and intensity of adverse events or withdrawals over the whole treatment period
Time Frame
three weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Graz
Country
Austria
City
Hagenow
Country
Germany
City
Bucharest
Country
Romania
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Tolerability of Propiverine Hydrochloride in Patients With Neurogenic Detrusor Overactivity
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