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

27 dicembre 2021 aggiornato da: 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

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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

Tipo di studio

Interventistico

Iscrizione (Anticipato)

180

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Taiwan
      • Taipei City, Taiwan, 11217
        • Reclutamento
        • Taipei Veterans General Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

20 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Droga: mirabegron
mirabegron 50mg QD
Procedura: TTNS
transcutaneous tibial nerve stimulation
Sperimentale: 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
Droga: mirabegron
mirabegron 50mg QD
Procedura: TTNS
transcutaneous tibial nerve stimulation

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes from baseline to end of treatment (EoT) (Week 20) in OABSS
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes from baseline to Week 12 in OABSS
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Taipei Veterans General Hospital, Taiwan

Investigatori

  • Investigatore principale: Chih-Chieh Lin, MD/Phd, Taipei Veterans General Hospital, Taiwan

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

10 novembre 2021

Completamento primario (Anticipato)

1 settembre 2023

Completamento dello studio (Anticipato)

1 settembre 2023

Date di iscrizione allo studio

Primo inviato

22 novembre 2021

Primo inviato che soddisfa i criteri di controllo qualità

27 dicembre 2021

Primo Inserito (Effettivo)

12 gennaio 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 gennaio 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 dicembre 2021

Ultimo verificato

1 dicembre 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2021-09-003B

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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