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

NCT04420533 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-10-05

No results posted yet for this study

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

Interventions

BEHAVIORAL

Behavior therapy alone

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.

DRUG

Mirabegron 50 MG Extended Release Oral Tablet

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

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Tsang-Tang Hsieh, MD · Institutional Review Board Chang Gung Medical Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-05
Primary Completion
2022-05-31
Completion
2022-08-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04420533 on ClinicalTrials.gov