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NCT Number: NCT00691093

Study In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy

This is a observational study in patients treated with fesoterodine (Toviaz), who have failed on previous treatment for overactive bladder. It will collect epidemiological data and investigate the efficacy and tolerability of fesoterodine.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site, ?a?a, Slovakia

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About this study

patients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients older than 18 years
  • Patients with OAB after failure of previous antimuscarinic therapy - due to lack of efficacy: persistence of storage symptoms.
  • Required symptoms: micturition frequency 8 and more / 24 hours and urgency episodes ≥2 per day subjectively perceived as bothersome
  • Due to intolerance: persistent and/or unacceptable adverse events

Exclusion criteria

  • Hypersensitivity to the active substance or to peanut or soya or any of the excipients.
  • History of acute urinary retention (requiring catheterisation)
  • Gastric retention
  • Uncontrolled narrow angle glaucoma
  • Myasthenia gravis
  • Severe hepatic impairment (Child Pugh C)
  • Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe hepatic or renal impairment
  • Severe ulcerative colitis
  • Toxic megacolon.

Treatment and study plan

Fesoterodine

Drug

4 mg per 24 hours, possibility to increase to 8 mg depending on efficacy chronic treatment

Other names: TOVIAZ

Primary outcomes

  1. Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit

    Time frame: Baseline, Month 1, Month 2, Month 3 or Early Termination (ET)

    Micturition frequency: mean number of 'day time' (i.e., the time the participant was awake) micturitions per 24 hours and calculated as the total number of 'day time' urinations, divided by the total diary days collected at that visit.

  2. Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4

    Time frame: Baseline, Month 1, Month 2, Month 3 or ET

    Nocturnal frequency: mean number of 'night time' (the time the participant was asleep and the urge to urinate woke him/her up) micturitions and calculated as the total number of 'night time' urinations, divided by the total diary days collected at that visit.

  3. Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4

    Time frame: Baseline, Month 1, Month 2, Month 3 or ET

    UEF: mean number of micturition related urgency episodes per 24 hours and calculated as the total number of 'urgency' urinations (i.e., sudden urges to urinate and problems to delay micturition) divided by 3 (or if data for 3 days were not available, over the total number of diary days collected at that visit).

  4. Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4

    Time frame: Baseline, Month 1, Month 2, Month 3 or ET

    The mean number of UUI episodes: total number of UUI episodes, divided by the total diary days collected at that visit.

Secondary outcomes

  1. Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4

    Time frame: Baseline, Month 1, Month 2, Month 3 or ET

    The PVR urine volume: measured by an ultrasound scan.

  2. Patient's Global Evaluation of Fesoterodine

    Time frame: Baseline, Month 3 or ET

    The patients global evaluation of study medication was assessed via the question 'how would you rate your overall response to the study medication?' and was assessed on the four point categorical scale, ranging from 'Poor' to 'Excellent'.

  3. Clinical Global Evaluation of Fesoterodine

    Time frame: 12 weeks

    Clinical global evaluation of study medication was assessed via the question 'how would you rate the study medication the patient received for overactive bladder?,' and was assessed on the four point categorical scale, ranging from 'Poor' to 'Excellent.'

  4. Efficacy and Tolerability Compared to Previous Medication (Overall Treatment Effect Scale) at Visit 4

    Time frame: Month 3 or ET

    Overall Treatment Effect Scale: 3 questions from which a numeric score was derived. If a subject answered '(2) About the same' to question 1 then a score of 0 was given. If a subject answered '(1) Worse' to question 1, then a score between -7=a very great deal worse to -1=Almost the same, hardly worse at all was given depending on severity of their symptoms (determined from answer to question 2). If a subject answered '(3) Better' to question 1, then a score ranging from 1=Almost the same, hardly better at all to 7=A very great deal better, depending on their answer to question 3, was given.

  5. Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale

    Time frame: Baseline, Month 3 or ET

    Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.

  6. Change From Baseline in Total Scores of OAB-q at Visit 4

    Time frame: Baseline, Month 3 or ET

    Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.

  7. Time To Onset Of Treatment Response

    Time frame: Month 1, Month 2, Month 3 or ET

    Participant's perception of treatment response assessment since the previous visit was noted at each visit. Time to onset of response was calculated in weeks from start of treatment.

  8. Study Doses

    Time frame: Month 3 or ET

    Number of subjects that changed doses throughout the study period.

  9. Reasons for Study Treatment Dose Changes

    Time frame: Month 3 or ET

    Possible change in the dose and the reasons for the change were collected and documented.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Observational Study In Patients With Overactive Bladder (OAB) Treated With Toviaz® After Failure Of Previous Antimuscarinic Therapy Due To Ineffectivity Or Intolerance.

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 5, 2008
Registry last updated
Nov 2, 2018

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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