Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Assessment of Patient-reported Goal Attainment in the Treatment of Female Overactive Bladder

29 maja 2013 zaktualizowane przez: KYU-SUNG LEE, Samsung Medical Center

Assessment of Patient-reported Goal Attainment in the Treatment of Female Overactive Bladder (Phase Ⅳ)

For many years, antimuscarinics have been first-line pharmacological treatment for OAB. A recent meta-analysis of randomised, controlled trials on antimuscarinic treatment of OAB concluded that the drugs provide significant improvements in OAB symptoms compared with placebo but that the benefits are of limited clinical significance. The analysis questioned the clinical significance of the trial results, one reason for which was the lack of data on the use of sensitive patient-driven criteria. Traditional symptomatic and urodynamic measures of treatment success may be meaningful to clinicians but often have little meaning to patients. Therefore, patient-reported outcomes (PROs), which provide a subjective measure of a patient's response to treatment, are useful. Recently, clinicians treating OAB have begun to recognize the value of PROs but still overlook the treatment efficacy in terms of patient-reported goal achievement (PGA).

Patients with OAB have combination of symptoms and the extent to which individual OAB symptoms affect patients varies. Also each patient can have different goal for the treatment. Therefore, assessing the degree of goal achievement in each patient can provide a new aspect of treatment benefit.

This controlled study will advance the understanding of OAB in terms of patient-centered treatments goals and goal achievement and will provide a new aspect of treatment benefit.

Przegląd badań

Szczegółowy opis

  1. Objectives

    1. Primary objective: To explore the "Patient-reported Goal Attainment (PGA)" after 12 weeks of treatment with tolterodine extended-release (ER) 4mg in female overactive bladder (OAB) patients.
    2. Secondary objective: To explore the patient-reported treatment goals and the efficacy of tolterodine on the patient-reported outcomes (PROs), micturition diary parameters, and safety parameters from baseline to 12 weeks of treatment in female OAB patients.
  2. Specific aim

    : To compare the efficacy of tolterodine ER 4mg with that of placebo, on PROs in terms of PGA after 12 weeks of treatment in female OAB patients.

  3. Experimental/research design

    1. 12-week randomized, placebo-controlled, double-blind, parallel-group, prospective study in Korean women with symptoms of OAB
    2. Treatment: Each patient will receive tolterodine ER (4 mg, qd) or placebo (randomized in the ratio of 1:1) for 12 weeks.
    3. Time schedule Start date: 01/Jan/2009 Finish date: 01/Sep/2009 Duration of washout: 7 days Duration of run-in: 7 days Duration of enrollment period: 5 months Duration of treatment period: 12 weeks Completion of analysis: 6 weeks

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

56

Faza

  • Faza 4

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 80 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Kobieta

Opis

Inclusion Criteria:

  1. Female aged ≥ 18 and ≤ 80 years
  2. Symptoms of OAB as verified by the screening 3 day micturition diary, defined by:

    Mean urinary frequency ≥8 times/24 hours Mean number of urgency episodes ≥ 2 episode/24 hours

  3. Symptoms of OAB for ≥ 3 months.
  4. Ability and willingness to correctly complete the micturition diary and questionnaire
  5. Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits

Exclusion Criteria:

  1. Subjects with stress incontinence or mixed stress/urge incontinence where stress incontinence is the predominant component based on prior history.
  2. Significant hepatic or renal disease, defined as having twice the upper limit of the reference range for serum concentrations of aspartate amino- transferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]), alkaline phosphatase or creatinine.
  3. Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
  4. Symptomatic acute urinary tract infection (UTI) during the run-in period
  5. Recurrent UTI defined as having been treated for symptomatic UTI > 4 times in the last year
  6. Diagnosed or suspected interstitial cystitis
  7. Clinically significant bladder outlet obstruction or poor detrusor function defined by clinical symptoms and investigator's opinion according to local standard of care
  8. Previous history of major urethral and/or bladder surgery
  9. History of radiation treatment (external or interstitial) to pelvic organs or external genitalia for any reason.
  10. Subjects with neuropathology that could affect the lower urinary tract or nerve supply
  11. Patients with marked cystocele or other clinically significant pelvic prolapse.
  12. Subjects with current (within 2 years) urogenital neoplasms or malignancies including bladder, uterine or cervical cancer
  13. Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with: Any anticholinergic drugs other than trial drug Any drug treatment for overactive bladder
  14. On an unstable dosage of any drug with anticholinergic side effects, or expected to start such treatment during the study
  15. Subjects currently taking tricyclic antidepressants, diuretics or alpha blockers who have not been on a stable dose of these medications for at least one month
  16. Current administration of a selective serotonin reuptake inhibitor (SSRI) and has not been on a stable dose for at least three months
  17. Receipt of any electrostimulation or bladder training within the 14 days before randomization, or expected to start such treatment during the study
  18. An indwelling catheter or practicing intermittent self-catheterization
  19. Use of any investigational drug within 1 months preceding the start of the study
  20. Patients with chronic constipation or history of severe constipation
  21. Pregnant or nursing women
  22. Sexually active females of childbearing potential not using reliable contraception for at least 1 month prior to study start and not agreeing to use such methods during the entire study period and for at least 1 month thereafter *Reliable contraceptive methods are defined as intrauterine devices (IUDs), combination type contraceptive pills, hormonal implants, double barrier method, injectable contraceptives and surgical procedures (tubal ligation or vasectomy).
  23. Any other condition which makes the patient unsuitable for inclusion.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Komparator placebo: Placebo
Placebo raz dziennie
Identical Placebo once daily
Eksperymentalny: Tolterodine ER
Tolterodine ER 4mg once daily
Tolterodine extended-release (ER) 4mg once daily for 12 weeks
Inne nazwy:
  • Detrusitol ER 4mg

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Ramy czasowe
Percentage of goal attainment using visual analog scale (VAS) at visit 3 and 4
Ramy czasowe: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks)
visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks)

Miary wyników drugorzędnych

Miara wyniku
Ramy czasowe
Assessment of patient-reported treatment goal
Ramy czasowe: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks)
visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks)
Patient-reported outcomes
Ramy czasowe: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),
visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),
Micturition diary efficacy parameters
Ramy czasowe: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),
visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),
Safety parameters
Ramy czasowe: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),
visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Współpracownicy

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 lutego 2009

Zakończenie podstawowe (Rzeczywisty)

1 stycznia 2012

Ukończenie studiów (Rzeczywisty)

1 stycznia 2012

Daty rejestracji na studia

Pierwszy przesłany

2 lutego 2009

Pierwszy przesłany, który spełnia kryteria kontroli jakości

3 lutego 2009

Pierwszy wysłany (Oszacować)

4 lutego 2009

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

30 maja 2013

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 maja 2013

Ostatnia weryfikacja

1 maja 2013

Więcej informacji

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Tolterodine extended-release (ER) 4mg

Subskrybuj