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

27 grudnia 2021 zaktualizowane przez: 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

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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

Typ studiów

Interwencyjne

Zapisy (Oczekiwany)

180

Faza

  • Faza 4

Kontakty i lokalizacje

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

Kontakt w sprawie studiów

Lokalizacje studiów

  • Tajwan
      • Taipei City, Tajwan, 11217
        • Rekrutacyjny
        • Taipei Veterans General Hospital
        • Kontakt:

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

20 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

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: Zadanie krzyżowe
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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
Lek: mirabegron
mirabegron 50mg QD
Procedura: TTNS
transcutaneous tibial nerve stimulation
Eksperymentalny: 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
Lek: mirabegron
mirabegron 50mg QD
Procedura: TTNS
transcutaneous tibial nerve stimulation

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Changes from baseline to end of treatment (EoT) (Week 20) in OABSS
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Changes from baseline to Week 12 in OABSS
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Taipei Veterans General Hospital, Taiwan

Śledczy

  • Główny śledczy: Chih-Chieh Lin, MD/Phd, Taipei Veterans General Hospital, Taiwan

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 (Rzeczywisty)

10 listopada 2021

Zakończenie podstawowe (Oczekiwany)

1 września 2023

Ukończenie studiów (Oczekiwany)

1 września 2023

Daty rejestracji na studia

Pierwszy przesłany

22 listopada 2021

Pierwszy przesłany, który spełnia kryteria kontroli jakości

27 grudnia 2021

Pierwszy wysłany (Rzeczywisty)

12 stycznia 2022

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

12 stycznia 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

27 grudnia 2021

Ostatnia weryfikacja

1 grudnia 2021

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2021-09-003B

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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