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Sequencing and Combination of Mirabegron and TTNS in Overactive Bladder Syndrome: a Multicenter, Randomized, Open-label, Crossover Trial

2021년 12월 27일 업데이트: Taipei Veterans General Hospital, Taiwan

Sequencing and Combination of Mirabegron and Transcutaneous Tibial Nerve Stimulation (TTNS) in Overactive Bladder Syndrome: a Multicenter, Randomized, Open-label, Crossover Trial

Research question:

A wealth of existing research has established the independent effectiveness of mirabegron and neuromodulation in the treatment of overactive bladder syndrome. Optimizing the use of these effective and well-tolerated treatment modalities is an important clinical goal and warrants further research. The primary aim of this trial is to answer the questions: how does varying the treatment sequence involving mirabegron and transcutaneous tibial nerve stimulation (TTNS) affect efficacy and patient acceptance and what is the second-line efficacy of either treatment modality?

Primary objective:

To evaluate improvement in storage symptoms, as measured by changes in Overactive Bladder Symptom Score (OABSS), International Prostate Symptom Score (IPSS) and parameters of voiding diary, in overactive bladder (OAB) patients receiving mirabegron or TTNS as first-line therapy when crossed over to second-line therapy with the opposite treatment modality

Secondary objectives:

To evaluate improvement in symptoms, as measured by changes in OABSS, IPSS and parameters of voiding diary, on first-line therapy with mirabegron or TTNS followed by combination multi-modal therapy To evaluate the effect of multi-modal treatment approach on patient's perception of treatment satisfaction and symptom control To evaluate urodynamic profiles of patients treated with multi-modal approach

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

Study design: Prospective, randomized, multicenter, open-label, cross-over trial Treatment sequence: randomized with 1:1 ratio to either Sequence A or Sequence B

Sequence A: mirabegron 50mg monotherapy x 8 weeks -> multi-modal combination treatment x 4 weeks -> TTNS monotherapy x 8 weeks Sequence B: TTNS monotherapy x 8 weeks -> multi-modal combination treatment x 4 weeks -> mirabegron 50mg monotherapy x 8 weeks

Patient population: adults ≥ 20 years who have experienced symptoms of OAB, as defined by International Continence Society (ICS) diagnostic criteria, for at least 3 months

Sample size: approximately 180 patients

연구 유형

중재적

등록 (예상)

180

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 대만
      • Taipei City, 대만, 11217
        • 모병
        • Taipei Veterans General Hospital
        • 연락하다:

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

20년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Adult OAB patients ≥20 years
  • Diagnosed with moderate to severe OAB (with or without urgency incontinence) based on OABSS >5 and clinical assessment, with UUI-predominant presentation, for at least 3 months
  • Able to receive TTNS and accommodate treatment logistics (30 min per on-site session, twice weekly)
  • Provided informed consent to participate in the study

Exclusion Criteria:

  • Neurologic conditions associated with OAB symptoms
  • History of stress urinary incontinence
  • Use of intravesical onabotulinumoxinA within recent 6 months
  • Postvoid residual urine volume (PVR) ≥ 100mL
  • Evidence of active urinary tract infection or urinary tract stone at screening
  • Genitourinary tract operation during the 3-month period prior to baseline
  • Confirmed or suspected genitourinary tract or pelvic malignancy
  • History of uncontrolled hypertension (systolic >160 mmHg and/or diastolic >110 mmHg)
  • History of intolerance to mirabegron
  • Patients with pacemakers or implantable defibrillators
  • Patients prone to excessive bleeding
  • Patients with nerve damage that could impact percutaneous tibial nerve or pelvic floor function
  • Patients who are pregnant or planning to become pregnant during the duration of treatment
  • History of medical conditions or presence of patient factors that, in the judgement of the investigator, would preclude adherence to study protocol

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: 크로스오버 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Sequence A
mirabegron 50mg OD x 8 weeks, followed by mirabegron 50mg OD and TTNS for 4 weeks, followed by TTNS twice a week x 8 weeks
의약품: mirabegron
mirabegron 50mg QD
절차: TTNS
transcutaneous tibial nerve stimulation
실험적: Sequence B
TTNS twice a week x 8 weeks, followed by mirabegron 50mg OD and TTNS for 4 weeks, followed by mirabegron 50mg OD x 8 weeks
의약품: mirabegron
mirabegron 50mg QD
절차: TTNS
transcutaneous tibial nerve stimulation

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Changes from baseline to end of treatment (EoT) (Week 20) in OABSS
기간: Baseline and Week 20
Changes from baseline to Week 20 in OABSS (Overactive Bladder Symptom Score) (a lower OABSS score represents a better outcome). Symptom improvement is defined as OABSS total score decreased by ≥ 3 points at EoT
Baseline and Week 20

2차 결과 측정

결과 측정
측정값 설명
기간
Changes from baseline to Week 12 in OABSS
기간: Baseline and Week 12
Changes from baseline to Week 12 in OABSS (Overactive Bladder Symptom Score) (a lower OABSS score represents a better outcome)
Baseline and Week 12
Changes from baseline to Week 12 and 20/end of treatment (EoT) in IPSS
기간: Baseline, and Week 12 and 20
Changes from baseline in IPSS (International Prostate Symptom Score) at Week 12 and 20 (a lower IPSS represents a better outcome)
Baseline, and Week 12 and 20
Change from Baseline to Week 12 and 20/end of treatment (EoT) in Mean Number of Micturitions per 24 Hours
기간: Baseline, and Week 12 and 20
The average number of micturitions (urinations) per 24 hours is derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days prior to clinic visits at Baseline and Week 12 and 20/end of treatment (EoT).
Baseline, and Week 12 and 20
Change from Baseline to Week 12 and 20/end of treatment (EoT) in Mean Number of Nocturia Episodes per 24 Hours
기간: Baseline, and Week 12 and 20
Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinates (excluding incontinence only episodes) during sleeping time per day is derived from a micturition diary in which a patient records for 3 days prior to clinic visits at Baseline and Week 12 and 20/end of treatment (EoT).
Baseline, and Week 12 and 20
Change from Baseline to Week 12 and 20/end of treatment (EoT) in Mean Number of Urgency Episodes per 24 Hours
기간: Baseline, and Week 12 and 20
The average number of urgency episodes (the sudden, compelling desire to pass urine that is difficult to defer) is derived from episodes reocrded by the patient in a micturition diary in which a patient completes for 3 days prior to clinic visits at Baseline and Week 12 and 20/end of treatment (EoT).
Baseline, and Week 12 and 20
Change from Baseline to Week 12 and 20/end of treatment (EoT) in Mean Number of Urgency Incontinence Episodes per 24 Hours
기간: Baseline, and Week 12 and 20
The involuntary leakage of urine accompanied or immediately proceeded by urgency, derived from the number of incontinence episodes recorded by the patient in a micturition diary in which a patient completes for 3 days prior to clinic visits at Baseline and Week 12 and 20/end of treatment (EoT).
Baseline, and Week 12 and 20
Changes from Week 8 to Week 20 in OABSS
기간: Week 8 to Week 20
Changes from Week 8 to Week 20 in OABSS (Overactive Bladder Symptom Score) (a lower OABSS represents a better outcome)
Week 8 to Week 20
Changes from Week 8 to Week 20 in IPSS
기간: Week 8 to Week 20
Changes from Week 8 to Week 20 in IPSS (International Prostate Symptom Score) (a lower IPSS represents a better outcome)
Week 8 to Week 20
Changes from Week 8 to Week 20 in Mean Number of Micturitions per 24 Hours
기간: Week 8 to Week 20
The average number of micturitions (urinations) per 24 hours is derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a 3-day micturition diary.
Week 8 to Week 20
Changes from Week 8 to Week 20 in Mean Number of Nocturia Episodes per 24 Hours
기간: Week 8 to Week 20
Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinates (excluding incontinence only episodes) during sleeping time per day is derived from the 3-day patient micturition diary.
Week 8 to Week 20
Changes from Week 8 to Week 20 in Mean Number of Urgency Episodes per 24 Hours
기간: Week 8 to Week 20
The average number of urgency episodes (the sudden, compelling desire to pass urine that is difficult to defer) derived from episodes recorded by the patient in a 3-day micturition diary
Week 8 to Week 20
Changes from Week 8 to Week 20 in Mean Number of Urgency Incontinence Episodes per 24 Hours
기간: Week 8 to Week 20
The involuntary leakage of urine accompanied or immediately proceeded by urgency, derived from the number of incontinence episodes recorded by the patient in a 3-day micturition diary
Week 8 to Week 20
Changes from Week 12 to Week 20 in OABSS
기간: Week 12 to Week 20
Changes from Week 12 to Week 20 in OABSS (Overactive Bladder Symptom Score) (a lower OABSS represents a better outcome)
Week 12 to Week 20
Changes from Week 12 to Week 20 in IPSS
기간: Week 12 to Week 20
Changes from Week 12 to Week 20 in IPSS (International Prostate Symptom Score) (a lower IPSS represents a better outcome)
Week 12 to Week 20
Changes from Week 12 to Week 20 in Mean Number of Micturitions per 24 Hours
기간: Week 12 to Week 20
The average number of micturitions (urinations) per 24 hours is derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a 3-day micturition diary.
Week 12 to Week 20
Changes from Week 12 to Week 20 in Mean Number of Nocturia Episodes per 24 Hours
기간: Week 12 to Week 20
Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinates (excluding incontinence only episodes) during sleeping time per day is derived from the 3-day patient micturition diary.
Week 12 to Week 20
Changes from Week 12 to Week 20 in Mean Number of Urgency Episodes per 24 Hours
기간: Week 12 to Week 20
The average number of urgency episodes (the sudden, compelling desire to pass urine that is difficult to defer) derived from episodes recorded by the patient in a 3-day micturition diary
Week 12 to Week 20
Changes from Week 12 to Week 20 in Mean Number of Urgency Incontinence Episodes per 24 Hours
기간: Week 12 to Week 20
The involuntary leakage of urine accompanied or immediately proceeded by urgency, derived from the number of incontinence episodes recorded by the patient in a 3-day micturition diary
Week 12 to Week 20
Changes from baseline to Week 12 and 20/end of treatment (EoT) in Overactive Bladder Questionnaire-Short Form (OAB-Q-SF) score
기간: Baseline, and Week 12 and 20
Overactive Bladder Questionnaire-Short Form (OAB-Q-SF) is a participant-reported instrument consisting of 19 items that assess the degree to which a participant is bothered by OAB symptoms, and the degree of impact of OAB symptoms on daily life. Participants rate each item using a 6-point Likert Scale ranging from "Not at all" to "A very great deal" for the symptom bother items and "none of the time" to "All of the time" for the Health Related Quality of Life (HRQL) items.
Baseline, and Week 12 and 20
Changes from baseline to Week 12 and 20/end of treatment (EoT) in Bladder Assessment Tool (BAT) score
기간: Baseline, and Week 12 and 20
Bladder Assessment Tool (BAT) is a participant-reported instrument consisting of 17 questions regarding the symptoms, bothering, impacts and treatment satisfaction in the past 7 days. Scores range from 0 to 88, a reduction in BAT score indicates an improvement.
Baseline, and Week 12 and 20
Changes from baseline to Week 12 and 20/end of treatment (EoT) in Treatment Satisfaction-Visual Analog Scale (TS-VAS) score
기간: Baseline, and Week 12 and 20
Treatment Satisfaction-Visual Analog Scale (TS-VAS) is a quantitative instrument assessing participant improvement in participants with OAB. A score of 10 on the TS-VAS indicates complete satisfaction, whereas a positive change from baseline indicates improvement.
Baseline, and Week 12 and 20

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Taipei Veterans General Hospital, Taiwan

수사관

  • 수석 연구원: Chih-Chieh Lin, MD/Phd, Taipei Veterans General Hospital, Taiwan

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 (실제)

2021년 11월 10일

기본 완료 (예상)

2023년 9월 1일

연구 완료 (예상)

2023년 9월 1일

연구 등록 날짜

최초 제출

2021년 11월 22일

QC 기준을 충족하는 최초 제출

2021년 12월 27일

처음 게시됨 (실제)

2022년 1월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 1월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 12월 27일

마지막으로 확인됨

2021년 12월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2021-09-003B

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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. .

과민성 방광 증후군에 대한 임상 시험

mirabegron에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Ireland

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다