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

NCT05188742 | Unknown Phase 4 DMC

• 1 other identifier: 2021-09-003B
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Overactive Bladder Syndrome

Keywords

overactive bladder; mirabegron; transcutaneous tibial nerve stimulation

Outcome Measures

Primary Outcomes (1)

• Changes from baseline to end of treatment (EoT) (Week 20) in OABSS

  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

Secondary Outcomes (21)

• Changes from baseline to Week 12 in OABSS

  Baseline and Week 12

• Changes from baseline to Week 12 and 20/end of treatment (EoT) in IPSS

  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

  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

  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

  Baseline, and Week 12 and 20

Study Arms (2)

Sequence A

EXPERIMENTAL

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

Drug: mirabegron; Procedure: TTNS

Sequence B

EXPERIMENTAL

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

Drug: mirabegron; Procedure: TTNS

Interventions

mirabegron DRUG

mirabegron 50mg QD

Sequence A; Sequence B

TTNS PROCEDURE

transcutaneous tibial nerve stimulation

Sequence A; Sequence B

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chih-Chieh Lin, MD/Phd

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chih-Chieh Lin, MD/Phd

CONTACT

+886-2-2875-7808; jayslylin@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: January 12, 2022
• Study Start: November 10, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: January 12, 2022

Record last verified: 2021-12

Locations

TW (1)