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OpenTrials
Completed

NCT Number: NCT02024945

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

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.

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Key information

Conditions

Overactive Bladder Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propiverine

Drug

Propiverine 15 mg tablets or 30 mg regulated release capsules

Other names: Mictonorm®, Mictonorm Uno®

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 31, 2013
Registry last updated
Dec 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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