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

2013년 5월 29일 업데이트: 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.

연구 개요

상세 설명

  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

연구 유형

중재적

등록 (실제)

56

단계

  • 4단계

연락처 및 위치

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연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 위약
위약 1일 1회
Identical Placebo once daily
실험적: Tolterodine ER
Tolterodine ER 4mg once daily
Tolterodine extended-release (ER) 4mg once daily for 12 weeks
다른 이름들:
  • 데트루시톨 ER 4mg

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Percentage of goal attainment using visual analog scale (VAS) at visit 3 and 4
기간: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks)
visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks)

2차 결과 측정

결과 측정
기간
Assessment of patient-reported treatment goal
기간: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks)
visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks)
Patient-reported outcomes
기간: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),
visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),
Micturition diary efficacy parameters
기간: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),
visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),
Safety parameters
기간: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),
visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

협력자

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2009년 2월 1일

기본 완료 (실제)

2012년 1월 1일

연구 완료 (실제)

2012년 1월 1일

연구 등록 날짜

최초 제출

2009년 2월 2일

QC 기준을 충족하는 최초 제출

2009년 2월 3일

처음 게시됨 (추정)

2009년 2월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2013년 5월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2013년 5월 29일

마지막으로 확인됨

2013년 5월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Tolterodine extended-release (ER) 4mg에 대한 임상 시험

3
구독하다