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

October 4, 2022 updated by: Chang Gung Memorial Hospital

Comparative Study Between Behavior Therapy and Behavior Therapy Plus Mirabegron 50mg in Sexually Active Men With Bothersome Overactive Bladder Symptoms - A Multicenter, Randomized Study

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Overactive bladder (OAB) syndrome is a subset of storage-predominant lower urinary tract symptoms (LUTS) and has a significant impact on quality of life. Men with OAB generally experience a reduced quality of life, which may include a negative impact on sexual function. A previous study revealed that OAB is associated with erectile dysfunction (ED; prevalence odds ratio, 1.5; 95% confidence interval, 1.1-2.2) to a level comparable with that of hypertension or diabetes, both of which are known risk factors for ED. Furthermore, men with OAB were nine and seven times more likely to report diminished sexual enjoyment and decreased sexual activity, respectively, due to urinary symptoms than men without urinary symptoms.

Behavior therapies are designed as first- line treatment for the treatment of OAB with or without concomitant medication. Mirabegron, a selective β3 adrenoceptor agonist, is indicated for the treatment of OAB. Earlier research studying the role and distribution of β3-adrenoreceptors revealed that the receptors exert other physiological functions such as lipolysis and are present not only in adipose tissue but also in human gall bladder, colon, prostate, skeletal muscles and corpus cavernosum (CC) smooth muscles. It was found that activation by a selective experimental β3-receptor agonist, BRL 37344, elicited relaxation of human CC smooth muscle via a cGMP-dependent but NO-independent mechanism, leading to observable β3-receptor-mediated vasorelaxant tone of CC. The potential effect of β3-receptor agonism at human CC mediated by highly selective mirabegron in both human CC and rat CC that mirabegron markedly relaxed isolated CC strips by activating β3-adrenoceptors localized in cavernosal smooth muscle cells, independently of the NO-cGMP pathway. Recently, intra-cavernosal injection of mirabegron improved erectile function and neurogenic relaxation of corpus cavernosum in diabetic rats.

These early results have spurred research interest in mirabegron-induced CC relaxation and encouraged further clinical studies observing and evaluating the effect of mirabegron on male sexual function. Researchers at Johns Hopkins University has recently completed recruitment of a phase 1 interventional trial (NCT02916693) that aimed to address the hypothesis that activation of β3-adrenoceptors by mirabegron offers an alternative pharmacologic pathway for the treatment of erectile dysfunction. A preliminary small-scale prospective interventional study including 128 male LUTS patients treated with mirabegron 50 mg, 34 of whom had diagnosis of OAB and were sexually active, showed that mirabegron usage did not improve erectile function, as evaluated by International Index of Erectile Function (IIEF-5 4.9% decrease at 4-week; p = 0.106, and 9.1% decrease at 12-week follow-up; p = 0.077). However, the IIEF-5 was significantly decreased in the higher baseline IIEF-5 (≥17) group (11.7% decrease; p = 0.044), noncoronary artery disease (13.2%; p = 0.007) group and non-DM group (13.9% decrease; p = 0.021) at 12-week follow-up.

The accumulated research output warrants the initiation of a prospective study involving a larger patient cohort to evaluate the effect of mirabegron on male sexual function in addition to alleviate OAB symptoms. 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).

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Chang Gung Memorial Hospital, Chang Gung University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Behavior therapy alone
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.
Experimental: Behavior therapy plus mirabegron 50mg
Behavior therapy plus Betmiga prolonged-release tablets (mirabegron) 50mg QDAC PO
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
Other Names:
  • Mirabegron 50 MG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in OABSS at Week 12
Time Frame: Baseline and 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
Time Frame: Baseline and 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in OABSS at Week 4
Time Frame: Baseline and Week 4
Change from baseline in OABSS (Overactive Bladder Symptom Score) at Week 12 (lower OABSS score represent a better outcome)
Baseline and Week 4
Change from baseline in IIEF-5 at Week 4
Time Frame: Baseline and Week 4
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 4
Change from baseline in MSHQ-EjD Short Form score at Week 4
Time Frame: Baseline and Week 4
Change from baseline in MSHQ-EjD (Male Sexual Health Questionnaire -Ejaculatory Domain) Short Form score at Week 4 (higher MSHQ-EjD Short Form Q1-Q3 sum scores represent a better outcome; lowerer MSHQ-EjD Short Form Q4 score represent a better outcome)
Baseline and Week 4
Change from baseline in MSHQ-EjD Short Form score at Week 12
Time Frame: Baseline and Week 12
Change from baseline in MSHQ-EjD (Male Sexual Health Questionnaire -Ejaculatory Domain) Short Form score at Week 12 (higher MSHQ-EjD Short Form Q1-Q3 sum scores represent a better outcome; lower MSHQ-EjD Short Form Q4 score represent a better outcome)
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
Time Frame: Baseline, Week 4 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 (lower episode represent a better outcome)
Baseline, Week 4 and Week 12
Net change of Qmax from baseline to 1 and 3 months after the treatment day
Time Frame: Baseline, Week 4 and Week 12
Net change of maximum flow rate (Qmax) from baseline to 1 and 3 months after the treatment day (higher Qmax and voided volume represent a better outcome)
Baseline, Week 4 and Week 12
Net change of voided volume from baseline to 1 and 3 months after the treatment day
Time Frame: Baseline, Week 4 and Week 12
Net change of voided volume from baseline to 1 and 3 months after the treatment day (higher voided volume represent a better outcome)
Baseline, Week 4 and Week 12
Net change of PVR volume from baseline to 1 and 3 months after the treatment day
Time Frame: Baseline, Week 4 and Week 12
Net change of postvoid residual (PVR) volume from baseline to 1 and 3 months after the treatment day (lower PVR represent a better outcome)
Baseline, Week 4 and Week 12
Net change of IPSS from baseline to 1 and 3 months after the treatment day
Time Frame: Baseline, Week 4 and Week 12
Net change of IPSS (International prostate symptom score) from baseline to 1 and 3 months after the treatment day (lower IPSS represent a better outcome)
Baseline, Week 4 and Week 12
Net change of PPBC score from baseline to 1 and 3 months after the treatment day
Time Frame: Baseline, Week 4 and Week 12
Net change of PPBC score (Patient perception of bladder condition) from baseline to 1 and 3 months after the treatment day (lower PPBC represent a better outcome)
Baseline, Week 4 and Week 12
Net changes of the GRA
Time Frame: Baseline, Week 4 and Week 12
Global response assessment (GRA) of satisfaction by the patient (categorized into -3, -2, -1, 0, 1, 2, 3, indicating markedly worse to markedly improved) at 1 and 3 months after the treatment day. An improvement of GRA by 2 scales is considered effective.
Baseline, Week 4 and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2020

Primary Completion (Actual)

May 31, 2022

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

June 2, 2020

First Submitted That Met QC Criteria

June 4, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

October 5, 2022

Last Update Submitted That Met QC Criteria

October 4, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202000790A3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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