Efficacy, Tolerability and Impact on Quality of Life of Propiverine in Patients With Overactive Bladder Syndrome

Completed

• Conditions: Overactive Bladder Syndrome
• Interventions: Drug: Propiverine

• Registration Number: NCT02024945
• Lead Sponsor: Takeda

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.

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-12
• Study First Submitted: 2013-12-28
• Study First Submitted QC: 2013-12-28
• Last Update Submitted: 2013-12-28
• Study First Posted: 2013-12-31
• Last Update Posted: 2013-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 437

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Propiverine	Propiverine	Participants with symptoms of OAB, prescribed propiverine in accordance with the summary of product characteristics (SPC).

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Quality of Life (QoL) as assessed by the King's Health Questionnaire (KHQ) at Weeks 4 and 12	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	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	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	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

Name	Time	Method
Patient and Investigator Assessment of Tolerability of Propiverine at Weeks 4 and 12	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.
Change from Baseline in Urine Volume per Void at Weeks 4 and 12	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	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.