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

• ClinicalTrials.gov Identifier: NCT01530620
• Recruitment Status: Completed
• First Posted: February 10, 2012
• Last Update Posted: February 10, 2012
• Sponsor: APOGEPHA Arzneimittel GmbH
• Information provided by (Responsible Party): APOGEPHA Arzneimittel GmbH

Tracking Information

• First Submitted Date: February 2, 2012
• First Posted Date: February 10, 2012
• Last Update Posted Date: February 10, 2012
• Study Start Date: December 2004
• Actual Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 9, 2012)

Reflex volume (cystometry) [ Time Frame: three weeks ]

Change in reflex volume compared to baseline and compared between the two treatment arms

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: February 9, 2012)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• 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

Intervention

• Drug: Propiverine hydrochloride ER (extended release)
  45 mg capsule (1x1/d)
  Other Names:

  • Mictonorm UNO 45
  • Detrunorm XL 45
• Drug: Propiverine hydrochloride IR (immediate release)
  15 mg tablet (3x1/d)
  Other Names:

  • Mictonorm
  • Detrunorm

Study Arms

• Experimental: Propiverine hydrochloride ER
  45 mg
  Intervention: Drug: Propiverine hydrochloride ER (extended release)
• Active Comparator: Propiverine hydrochloride IR
  15 mg
  Intervention: Drug: Propiverine hydrochloride IR (immediate release)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 9, 2012): 66
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: July 2006
• Actual Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Germany, Romania

Administrative Information

• NCT Number: NCT01530620
• Other Study ID Numbers: 8405010
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: APOGEPHA Arzneimittel GmbH
• Study Sponsor: APOGEPHA Arzneimittel GmbH
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: APOGEPHA Arzneimittel GmbH
• Verification Date: February 2012