Comparative Study Between Behavior Therapy and Behavior Therapy Plus Mirabegron in Sexually Active Men With OAB Symptoms

NCT04420533 | Completed

• 1 other identifier: 202000790A3
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate and compare the therapeutic effects on OAB symptoms, and sexual functions, in terms of erectile function and ejaculatory function, in sexually active OAB male treated with behavior therapy or behavior therapy plus Mirabegron (50 mg).

Conditions

Urinary Bladder, Overactive; Sexual Behavior; Sexual Activity; Behavior Therapy; Sexual Function Disturbances

Keywords

overactive bladder; mirabegron 50mg

Outcome Measures

Primary Outcomes (2)

• Change from baseline in OABSS at Week 12

  Change from baseline in OABSS (Overactive Bladder Symptom Score) at Week 12 (lower OABSS score represent a better outcome)

  Baseline and Week 12

• Change from baseline in IIEF-5 at Week 12

  Change from baseline in IIEF-5 (International Index of Erectile Function) at Week 12 (higher IIEF-5 score represent a better outcome)

  Baseline and Week 12

Secondary Outcomes (11)

• Change from baseline in OABSS at Week 4

  Baseline and Week 4

• Change from baseline in IIEF-5 at Week 4

  Baseline and Week 4

• Change from baseline in MSHQ-EjD Short Form score at Week 4

  Baseline and Week 4

• Change from baseline in MSHQ-EjD Short Form score at Week 12

  Baseline and Week 12

• Net change of Frequency episode, nocturia episode, urgency episode, UUI episodes in 3-day voiding diary from baseline to 1 and 3 months after the treatment day

  Baseline, Week 4 and Week 12

Study Arms (2)

Behavior therapy alone

ACTIVE COMPARATOR

Behavior therapy alone

Behavioral: Behavior therapy alone

Behavior therapy plus mirabegron 50mg

EXPERIMENTAL

Behavior therapy plus Betmiga prolonged-release tablets (mirabegron) 50mg QDAC PO

Behavioral: Behavior therapy alone; Drug: Mirabegron 50 MG Extended Release Oral Tablet

Interventions

Behavior therapy alone BEHAVIORAL

1. reduction of fluid intake at specific times aimed at reducing urinary frequency when most inconvenient; 2. moderation of intake of caffeine or alcohol, which may have a diuretic and irritant effect, thereby increasing fluid output and enhancing frequency, urgency and nocturia; 3. use of relaxed and double-voiding techniques; 4. urethral milking to prevent post-micturition dribble; 5. distraction techniques such as penile squeeze, breathing exercises, perineal pressure, and mental tricks to take the mind off the bladder and toilet, to help control storage symptoms; 6. bladder retraining that encourages men to hold on when they have sensory urgency; 7. reviewing the medication and optimising the time of administration or substituting drugs for others that have fewer urinary effects (these recommendations apply especially to diuretics); 8. providing necessary assistance when there is impairment of dexterity, mobility or mental state; 9. treatment of constipation.

Behavior therapy alone; Behavior therapy plus mirabegron 50mg

Mirabegron 50 MG Extended Release Oral Tablet DRUG

Betmiga prolonged-release tablets (mirabegron) 50mg QDAC PO

Also known as: Mirabegron 50 MG

Behavior therapy plus mirabegron 50mg

Eligibility Criteria

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

You may qualify if:

• Sexually active men with OAB ≥ 20 years
• Diagnosed with OAB based on OABSS (OABSS urgency score of ≥2 and sum score of ≥3)
• Patients can sign informed consent and record voiding diary

You may not qualify if:

• Concurrent use of PDE5 inhibitor or testosterone therapy during study period
• History of stress urinary incontinence
• Neurologic conditions associated with OAB symptoms
• Evidence of active urinary tract infection or urinary tract stone at screening
• Confirmed or suspected genitourinary tract or pelvic malignancy
• Genitourinary tract operation during the 3-month period prior to baseline
• Postvoid residual urine volume (PVR) ≥ 100 mL
• History of uncontrolled hypertension (systolic \>180 mmHg and/or diastolic \>110 mmHg)
• History of intolerance to mirabegron
• History of medical conditions or presence of patient factors that, in the judgement of the investigator, would preclude adherence to study protocol
• Patient had received intravesical onabotulinumoxinA treatment within recent 6 months

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital, Chang Gung University College of Medicine

Kaohsiung City, 833, Taiwan

Location

Related Publications (9)

• Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.

  PMID: 11857671 BACKGROUND

• Chuang YC, Liu SP, Lee KS, Liao L, Wang J, Yoo TK, Chu R, Sumarsono B. Prevalence of overactive bladder in China, Taiwan and South Korea: Results from a cross-sectional, population-based study. Low Urin Tract Symptoms. 2019 Jan;11(1):48-55. doi: 10.1111/luts.12193. Epub 2017 Oct 2.

  PMID: 28967230 BACKGROUND

• Irwin DE, Milsom I, Reilly K, Hunskaar S, Kopp Z, Herschorn S, Coyne KS, Kelleher CJ, Artibani W, Abrams P. Overactive bladder is associated with erectile dysfunction and reduced sexual quality of life in men. J Sex Med. 2008 Dec;5(12):2904-10. doi: 10.1111/j.1743-6109.2008.01000.x.

  PMID: 19090944 BACKGROUND

• Coyne KS, Sexton CC, Thompson C, Kopp ZS, Milsom I, Kaplan SA. The impact of OAB on sexual health in men and women: results from EpiLUTS. J Sex Med. 2011 Jun;8(6):1603-15. doi: 10.1111/j.1743-6109.2011.02250.x. Epub 2011 Apr 14.

  PMID: 21492396 BACKGROUND

• Yamaguchi O, Chapple CR. Beta3-adrenoceptors in urinary bladder. Neurourol Urodyn. 2007;26(6):752-6. doi: 10.1002/nau.20420.

  PMID: 17600372 BACKGROUND

• Cirino G, Sorrentino R, di Villa Bianca Rd, Popolo A, Palmieri A, Imbimbo C, Fusco F, Longo N, Tajana G, Ignarro LJ, Mirone V. Involvement of beta 3-adrenergic receptor activation via cyclic GMP- but not NO-dependent mechanisms in human corpus cavernosum function. Proc Natl Acad Sci U S A. 2003 Apr 29;100(9):5531-6. doi: 10.1073/pnas.0931347100. Epub 2003 Apr 21.

  PMID: 12707413 BACKGROUND

• Gur S, Peak T, Yafi FA, Kadowitz PJ, Sikka SC, Hellstrom WJ. Mirabegron causes relaxation of human and rat corpus cavernosum: could it be a potential therapy for erectile dysfunction? BJU Int. 2016 Sep;118(3):464-74. doi: 10.1111/bju.13515. Epub 2016 May 26.

  PMID: 27124860 BACKGROUND

• Yilmaz-Oral D, Kaya-Sezginer E, Askin D, Hamurtekin Y, Gur S. Mirabegron, A Selective beta3-Adrenoceptor Agonist Causes an Improvement in Erectile Dysfunction in Diabetic Rats. Exp Clin Endocrinol Diabetes. 2021 Mar;129(4):296-302. doi: 10.1055/a-0869-7493. Epub 2019 Apr 12.

  PMID: 30978726 BACKGROUND

• Wu TH, Shen YC, Lee WC, Wang HJ, Chuang YC. Effect of mirabegron on erectile function in sexually active men with bothersome overactive bladder symptoms. J Chin Med Assoc. 2020 Jan;83(1):55-59. doi: 10.1097/JCMA.0000000000000208.

  PMID: 31567878 BACKGROUND

Related Links

• Management of Non-neurogenic Male LUTS. European Association of Urology, 2019 Guidelines
• ClinicalTrials.gov Identifier NCT02916693, Mirabegron For Erectile Dysfunction

MeSH Terms

Conditions

Urinary Bladder, Overactive; Sexual Behavior; Sexual Dysfunctions, Psychological

Interventions

Behavior Therapy; 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; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Tsang-Tang Hsieh, MD

  Institutional Review Board Chang Gung Medical Foundation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, multi-center, randomized, open label study in sexually active male OAB patients treated with behavior therapy alone or behavior therapy plus mirabegron 50mg OD in a 1:2 ratio.

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 9, 2020
• Study Start: June 5, 2020
• Primary Completion: May 31, 2022
• Study Completion: August 31, 2022
• Last Updated: October 5, 2022

Record last verified: 2022-10

Locations

TW (1)