Clinical trial NCT02024945: Efficacy, Tolerability and Impact on Quality of Life of Propiverine in Patients With Overactive Bladder Syndrome
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder Syndrome
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2013-12-31
Enrollment: 437
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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 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

Primary outcomes:
measure: Change from Baseline in Quality of Life (QoL) as assessed by the King's Health Questionnaire (KHQ) at Weeks 4 and 12
timeFrame: Baseline, Weeks 4 and 12
measure: Change from Baseline in Urination Urge at Weeks 4 and 12
timeFrame: Baseline, Weeks 4 and 12
measure: Change from Baseline in Incontinence episodes at Weeks 4 and 12
timeFrame: Baseline, Weeks 4 and 12
measure: Change from Baseline in Micturition Frequency including nocturia at Weeks 4 and 12
timeFrame: Baseline, Weeks 4 and 12
Secondary outcomes:
measure: Change from Baseline in Urine Volume per Void at Weeks 4 and 12
timeFrame: Baseline, Weeks 4 and 12
measure: Patient and Investigator Assessment of Efficacy of Propiverine at Weeks 4 and 12
timeFrame: Weeks 4 and 12
measure: Patient and Investigator Assessment of Tolerability of Propiverine at Weeks 4 and 12
timeFrame: 12 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: