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

NCT02024945 | Completed

• 2 other identifiers: MN-9999-401-BEU1111-1146-5884
• Study Type: observational
• Target: 437
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Overactive Bladder Syndrome

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline, Weeks 4 and 12

Secondary Outcomes (3)

• Change from Baseline in Urine Volume per Void at Weeks 4 and 12

  Baseline, Weeks 4 and 12

• Patient and Investigator Assessment of Efficacy of Propiverine at Weeks 4 and 12

  Weeks 4 and 12

• Patient and Investigator Assessment of Tolerability of Propiverine at Weeks 4 and 12

  12 Weeks

Study Arms (1)

Propiverine

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

Drug: Propiverine

Interventions

Propiverine DRUG

Propiverine 15 mg tablets or 30 mg regulated release capsules

Also known as: Mictonorm®, Mictonorm Uno®

Propiverine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. 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).

You may not qualify if:

• None, as per the SPC contra-indications

Sponsors & Collaborators

• Takeda: lead

MeSH Terms

Interventions

propiverine

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2013
• First Posted: December 31, 2013
• Study Start: November 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 31, 2013

Record last verified: 2013-12