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Trial record 1 of 1 for:    MN-9999-401-BE
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Efficacy, Tolerability and Impact on Quality of Life of Propiverine in Patients With Overactive Bladder Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT02024945
First received: December 28, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose
The purposes of this study were to assess Quality of Life (QoL) and urination urge, incontinence, and micturition frequency including nocturia after 4 and 12 weeks treatment with propiverine.

Condition Intervention Phase
Overactive Bladder Syndrome Drug: Propiverine Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Health-Related Quality of Life in Patients With Overactive Bladder Syndrome (OAB) Treated With Propiverine, and Its Efficacy and Tolerance in Daily Practice in Belgian General Practitioners and Urologists

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Change from Baseline in Quality of Life (QoL) as assessed by the King's Health Questionnaire (KHQ) at Weeks 4 and 12 [ Time Frame: Baseline, Weeks 4 and 12 ]
    The King's Health Questionnaire is a condition-specific health-related QoL instrument for the assessment of patients with lower urinary tract conditions including overactive bladder. It is a self-administered questionnaire containing 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep or energy, and severity of urinary symptoms). All domains were assessed in a range: 0-100, where 0=best and 100=worst outcome. Lower scores indicates better QoL.

  • Change from Baseline in Urination Urge at Weeks 4 and 12 [ Time Frame: Baseline, Weeks 4 and 12 ]
    Each participant kept a voiding diary and recorded urinary urgency. The diary was kept for 2 consecutive days within 7 days of the Baseline visit, and 2 consecutive days just before the Week 4 and 12 visits. The average urination urge was then calculated.

  • Change from Baseline in Incontinence episodes at Weeks 4 and 12 [ Time Frame: Baseline, Weeks 4 and 12 ]
    Each patient kept a voiding diary and episodes of incontinence. The diary was kept for 2 consecutive days within 7 days of the Baseline visit, and 2 consecutive days just before the Week 4 and 12 visits. The average number of incontinence episodes per 24 hours was calculated.

  • Change from Baseline in Micturition Frequency including nocturia at Weeks 4 and 12 [ Time Frame: Baseline, Weeks 4 and 12 ]
    Each patient kept a voiding diary and recorded the number of micturitions. The diary was kept for 2 consecutive days within 7 days of the Baseline visit, and 2 consecutive days just before the Week 4 and 12 visits. The average number of micturitions and nocturia episodes per 24 hours was calculated.


Secondary Outcome Measures:
  • Change from Baseline in Urine Volume per Void at Weeks 4 and 12 [ Time Frame: Baseline, Weeks 4 and 12 ]
    Mean volume per void (or amount of urine per urination) over 24 hours is based on a 2-day diary maintained by the participant.

  • Patient and Investigator Assessment of Efficacy of Propiverine at Weeks 4 and 12 [ Time Frame: Weeks 4 and 12 ]
    Evaluation of efficacy was assessed by participants and investigators on a 4 point scale. Participants and investigators reported efficacy as very good, good, sufficient, or insufficient.

  • Patient and Investigator Assessment of Tolerability of Propiverine at Weeks 4 and 12 [ Time Frame: 12 Weeks ]
    Evaluation of tolerability was assessed by participants and investigators on a 4 point scale. Participants and investigators reported tolerability as very good, good, sufficient, or insufficient.


Enrollment: 437
Study Start Date: November 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Propiverine
Participants with symptoms of OAB, prescribed propiverine in accordance with the summary of product characteristics (SPC).
Drug: Propiverine
Propiverine 15 mg tablets or 30 mg regulated release capsules
Other Names:
  • Mictonorm®
  • Mictonorm Uno®

Detailed Description:
The drug being tested in this study is called propiverine. Propiverine is being tested to evaluate Quality of Life (QoL) and improvement of OAB symptoms in people who take propiverine. The study will enroll approximately 1000 patients who the treating physician decided to treat with propiverine 15mg tablets or 30 mg regulated release capsules as part of their normal clinical practice. All participants will be asked to keep a voiding diary for 2 consecutive days and to complete a QoL questionnaire after 1st visit and before each subsequent visit. This multi-centre trial will be conducted in Belgium. The overall time to participate in this study is up to 12 weeks. Participants will make 3 visits to their healthcare provider.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with OAB symptoms, who the treating physician decided to treat with propiverine, were to be included by General Practitioners (GP) and urologists in private practice in Belgium.
Criteria

Inclusion Criteria:

  • 1. Written informed consent. 2. At least 18 years of age. 3. Patients with complaints of Overactive Bladder Syndrome (OAB) without urge incontinence, OAB with urge incontinence, or with mixed urinary incontinence. 4. Patients who consult their GP or an urologist for the first time with these complaints or who stopped their OAB treatment since at least one month. 5. Receiving a propiverine prescription according to the Summary of Product Characteristics (SPC).

Exclusion Criteria:

  • None, as per the SPC contra-indications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02024945

Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02024945     History of Changes
Other Study ID Numbers: MN-9999-401-BE
U1111-1146-5884 ( Other Identifier: World Health Organization )
Study First Received: December 28, 2013
Last Updated: December 28, 2013

Keywords provided by Takeda:
Drug therapy

Additional relevant MeSH terms:
Syndrome
Urinary Bladder, Overactive
Disease
Pathologic Processes
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Propiverine
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on June 27, 2017