Overactive Bladder SyndromeNCT02024945
Efficacy, Tolerability and Impact on Quality of Life of Propiverine in Patients With Overactive Bladder Syndrome
An observational study of Overactive Bladder Syndrome, run by Takeda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder Syndrome
- What is being tested?
- Propiverine
- Type of treatment
- Pill or oral medicine
- How many people
- 437 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- None, as per the SPC contra-indications
About this study
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
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.
Read the 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.
- Conditions
- Overactive Bladder Syndrome
- Being tested
- Propiverine
- Keywords
- Drug therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropiverineDrug
Also called Mictonorm®, Mictonorm Uno®
Propiverine 15 mg tablets or 30 mg regulated release capsules
| Study group | Role | What they receive |
|---|---|---|
| Propiverine | Participants with symptoms of OAB, prescribed propiverine in accordance with the summary of product characteristics (SPC). Receives: Drug: Propiverine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Quality of Life (QoL) as assessed by the King's Health Questionnaire (KHQ) at 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.
Measured: Baseline, Weeks 4 and 12
Change from Baseline in Urination Urge at 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.
Measured: Baseline, Weeks 4 and 12
Change from Baseline in Incontinence episodes at 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.
Measured: Baseline, Weeks 4 and 12
Change from Baseline in Micturition Frequency including nocturia at 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.
Measured: Baseline, Weeks 4 and 12
Secondary outcomes (3)
Change from Baseline in Urine Volume per Void at 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.
Measured: Baseline, Weeks 4 and 12
Patient and Investigator Assessment of Efficacy of Propiverine at 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.
Measured: Weeks 4 and 12
Patient and Investigator Assessment of Tolerability of Propiverine at Weeks 4 and 12
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.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startNov 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder SyndromeStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 437 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024945
- Sponsor's protocol ID
- MN-9999-401-BE
- Other IDs
- U1111-1146-5884
- Status last verified
- Dec 2013
- First submitted
- 28 Dec 2013
- Last updated
- 31 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02024945
- Acronym / sponsor ID
- MN-9999-401-BE
- Conditions
- Overactive Bladder Syndrome
- Keywords
- Drug therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 437 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 31 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Propiverine | – | Drug: PropiverineParticipants with symptoms of OAB, prescribed propiverine in accordance with the summary of product characteristics (SPC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- None, as per the SPC contra-indications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropiverineAlso: Mictonorm®, Mictonorm Uno®Propiverine 15 mg tablets or 30 mg regulated release capsules | Drug | Propiverine |
Primary outcome
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.
3 secondary outcomes
Change from Baseline in Urine Volume per Void at Weeks 4 and 12
Time frame: Baseline, Weeks 4 and 12
Patient and Investigator Assessment of Efficacy of Propiverine at Weeks 4 and 12
Time frame: Weeks 4 and 12
Patient and Investigator Assessment of Tolerability of Propiverine at Weeks 4 and 12
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Takeda
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder Syndrome, run by Takeda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2013.