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

2013年5月29日 更新者: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.

調査の概要

詳細な説明

  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

研究の種類

介入

入学 (実際)

56

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~80年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:トリプル

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター:プラセボ
プラセボを 1 日 1 回
Identical Placebo once daily
実験的:Tolterodine ER
Tolterodine ER 4mg once daily
Tolterodine extended-release (ER) 4mg once daily for 12 weeks
他の名前:
  • デトルシトールER 4mg

この研究は何を測定していますか?

主要な結果の測定

結果測定
時間枠
Percentage of goal attainment using visual analog scale (VAS) at visit 3 and 4
時間枠:visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks)
visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks)

二次結果の測定

結果測定
時間枠
Assessment of patient-reported treatment goal
時間枠:visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks)
visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks)
Patient-reported outcomes
時間枠:visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),
visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),
Micturition diary efficacy parameters
時間枠:visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),
visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),
Safety parameters
時間枠:visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),
visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

協力者

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2009年2月1日

一次修了 (実際)

2012年1月1日

研究の完了 (実際)

2012年1月1日

試験登録日

最初に提出

2009年2月2日

QC基準を満たした最初の提出物

2009年2月3日

最初の投稿 (見積もり)

2009年2月4日

学習記録の更新

投稿された最後の更新 (見積もり)

2013年5月30日

QC基準を満たした最後の更新が送信されました

2013年5月29日

最終確認日

2013年5月1日

詳しくは

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