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Completed

NCT Number: NCT02087098

A Study to Evaluate Quality of Life in Patients Switched to Solifenacin From Other Antimuscarinics

This is a 12 month non-interventional study with solifenacin succinate, evaluating the effect of solifenacin on quality of life (QoL) of patients previously treated with antimuscarinics (Males and Females with Overactive Bladder (OAB) symptoms withdrawing their treatment with antimuscarinics because of safety and/or efficacy reasons) - measured by Perception of Treatment Satisfaction (TS-VAS) and to evaluate the effect of solifenacin on quality of life measured by Over Active Bladder-q Short Form (OAB-q SF), EuroQol Group scoring system (EQ-5D-5L).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site CZ42003 Private Practice, Benešov, Czechia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient willing and able to complete the questionnaires
  • Diagnosis of OAB
  • Previous unsuccessful OAB medication (antimuscarinic treatment for at least 1 month) less than 4 weeks ago defined by:
  • number of micturitions > 8/24 h or
  • decrease in urgency urinary incontinence (UUI) or incontinence episodes / 24 h less than 50% or
  • decrease in urgency episodes / 24 h less than 50% or
  • decrease in number of micturitions / 24 h less than 20% or
  • not acceptable tolerability
  • Eligible to start Vesicare™ 5 or 10 mg according to Summary of Product Characteristics (SmPC)

Exclusion criteria

  • History of stress incontinence
  • Active urinary tract infection (confirmed by positive urine analysis)
  • Symptoms suggestive of severe Bladder Outlet Obstruction (BOO) defined as Peak urinary flow rate (Qmax) < 10ml/sc and/or Postvoid residual urine volume (PVR) > 150 ml
  • Uncontrolled Diabetes Mellitus
  • History of drug and/or alcohol abuse at the time of enrolment
  • History of acute urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony or toxic megacolon or severe ulcerative colitis), myasthenia gravis, uncontrolled narrow glaucoma or swallow anterior chamber or deemed to be at risk for these conditions.
  • Undergoing hemodialysis or has severe renal impairment or moderate hepatic impairment and who are on treatment with a potent CYP3A4 inhibitor
  • Previous treatment with solifenacin
  • Likely to participate in another study during study period of 12 months from study entry

Treatment and study plan

solifenacin

Drug

Patients with residual OAB symptoms (urge urinary incontinence, urgency, and frequency) after treatment with other antimuscarinics

Other names: Vesicare

Primary outcomes

  1. Change from baseline of Over Active Bladder questionnaire Short Form (OAB-q SF) score

    Time frame: baseline, month 6 and 12

  2. Change from baseline of Patient Assessment of Treatment Satisfaction (TS-VAS)

    Time frame: baseline, month 6 and 12

  3. Change from baseline in EuroQol Group system (EQ-5D-5L) score

    Time frame: baseline, month 6 and 12

Secondary outcomes

  1. Change in QoL according to previous antimuscarinic treatment and sex (assessed by: TS-VAS score, OAB-q SF score, EQ-5D-5L)

    Time frame: baseline, month 1, 3, 6 and 12

  2. Change from baseline in OAB symptoms assessed by micturition diary

    Time frame: baseline, month 1, 3, 6 and 12

    Mean number of urgency episode per 24 hours, mean number of micturition per 24 hours, mean number of nocturia episodes per 24 hours, mean number of urge incontinence (UUI) episodes per week

  3. Persistence to therapy (measured by proportion of Days Covered (PDC, threshold of 80 percent during the measurement period), median length of therapy (days))

    Time frame: 12 months

  4. Occurence of adverse drug reaction

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Astellas Pharma Europe B.V.

Industry

Registry information

Official study title

Czech Observational Study to Evaluate Quality of Life in Patients Switched to Vesicare™ (Solifenacin) From Other Antimuscarinics

Acronym: VEST

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 14, 2014
Registry last updated
Sep 13, 2016

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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