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Comparison of Solifenacin and Mirabegron in Treatment of Overactive Bladder Symptoms in Men After TURP

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ClinicalTrials.gov Identifier: NCT03632772
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Hann-Chorng Kuo, Buddhist Tzu Chi General Hospital

Brief Summary:

Urinary frequency urgency and urgency urinary incontinence (UUI) are commonly encountered in patients after transurethral prostatectomy (TURP) or transurethral incision of the prostate (TUIP). Antimuscarinics has been widely used to treat OAB and around 70% of patients can improve symptoms after treatment. Beta-3 adrenoceptor agonist (mirabegron) can also decrease DO and improve OAB symptoms. Combination treatment of solifenacin 5mg plus mirabegron 25 or 50mg was more effective than mirabegron 50mg alone, but with more anticholinergic side effects. However, there has been no clinical trial to compare which drug provides more benefit to decrease the OAB symptom severity immediately after TURP. This study tries to compare the safety and therapeutic efficacy between solifenacin and mirabegron in men with BPH and having OAB symptoms immediately after TURP.

This study was designed as a prospective, randomized trial to compare the safety and efficacy of OAB medication on the decrease of overactive bladder symptoms score (OABSS) and urgency severity score (USS) between solifenacin 5mg QD and mirabegron 50mg QD in men with BPH undergoing TURP. A total of 130 male patients with BPH and undergo TURP or TUIP will be enrolled. The primary end point is the change of USS from baseline to 4 weeks after catheter removal and starting OAB medication. Secondary end-points include the changes of OABSS, frequency episodes, urgency episodes, UUI episodes in the 3-day voiding diary, maximum flow rate (Qmax), voided volume and PVR, International Prostate Symptom Score (IPSS) and quality of life index (QoL-I) from baseline to 2 weeks and 4 weeks.

We expect that patients receiving solifenacin and mirabegron might have similar therapeutic effects on decrease of USS, but patients who received mirabegron might have less adverse events such as dry mouth or difficulty in urination.


Condition or disease Intervention/treatment Phase
Overactive Bladder Syndrome Drug: Solifenacin 5Mg Drug: Mirabegron 50 MG Phase 2

Detailed Description:

Introduction:

Urinary frequency urgency and urgency urinary incontinence (UUI) are commonly encountered in patients after transurethral prostatectomy (TURP) or transurethral incision of the prostate (TUIP). [1] Patients usually bother by these overactive bladder (OAB) symptoms. The causes of postprostatectomy OAB might be detrusor overactivity (DO) before TURP, increase afferent input due to acute inflammation after TURP, or a weak urethral sphincter which cannot hold urine at the bladder capacity. Antimuscarinics and beta-3 adrenoceptor agonist are two different classes of medication for OAB. [2] Antimuscarinics has been widely used to treat OAB and around 70% of patients can improve symptoms after treatment. Beta-3 adrenoceptor agonist (mirabegron) can also decrease DO and improve OAB symptoms. Combination treatment of solifenacin 5mg plus mirabegron 25 or 50mg was more effective than mirabegron 50mg alone, but with more anticholinergic side effects. [3] However, antimuscarnics might decrease detrusor contractility and result in increase of postvoid residual (PVR) volume. Current clinical studies reveal that mirabegron does not impair detrusor contractility or increase PVR. [4] Under this consideration, mirabegron has been widely used to treat male lower urinary tract symptoms (LUTS) due to benign prostate hyperplasia (BPH). [5] However, there has been no clinical trial to compare which drug provides more benefit to decrease the OAB symptom severity immediately after TURP. This study tries to compare the safety and therapeutic efficacy between solifenacin and mirabegron in men with BPH and having OAB symptoms immediately after TURP.

Material and methods:

Objectives and Endpoints: This study was designed as a prospective, randomized trial to compare the safety and efficacy of OAB medication on the decrease of overactive bladder symptoms score (OABSS) and urgency severity score (USS) between solifenacin 5mg QD and mirabegron 50mg QD in men with BPH undergoing TURP.

Randomization: Permuted block randomization method will be applied to generate randomization codes. Each randomization number will be assigned to individual patient according to the time-sequence for screened patient become eligible.

Expected Results:

Patients receiving solifenacin and mirabegron might have similar therapeutic effects on decrease of USS, but patients who received mirabegron might have less adverse events such as dry mouth or difficulty in urination.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparative Study of Solifenacin and Mirabegron in Treatment of Overactive Bladder Symptoms in Men After Transurethral Resection of the Prostate - A Randomized Prospective Study
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Solifenacin 5 mg for 4 weeks
Solifenacin 5 mg once-daily for 4 weeks.
Drug: Solifenacin 5Mg
We compared the safety and therapeutic efficacy between Solifenacin and Mirabegron in men with benign prostate hyperplasia and having overactive bladder symptoms immediately after Transurethral Resection of the Prostate.
Other Name: Vesicare

Experimental: Mirabegron 50 mg for 4 weeks
Mirabegron 50 mg once-daily for 4 weeks.
Drug: Mirabegron 50 MG
We compared the safety and therapeutic efficacy between Solifenacin and Mirabegron in men with benign prostate hyperplasia and having overactive bladder symptoms immediately after Transurethral Resection of the Prostate.
Other Name: Betmiga

No Intervention: Control: non treatment
Control: non treatment.



Primary Outcome Measures :
  1. Urgency Severity Scale (USS) [ Time Frame: from baseline to 4 weeks ]
    The change of USS from baseline to 4 weeks after catheter removal and starting OAB medication.


Secondary Outcome Measures :
  1. Overactive Bladder Symptom Score (OABSS) [ Time Frame: from baseline to 2 weeks and 4 weeks. ]
    The changes of OABSS

  2. frequency episodes, urgency episodes, urgency urinary incontinence (UUI) episodes in the 3-day voiding diary [ Time Frame: from baseline to 2 weeks and 4 weeks. ]
    The changes of frequency episodes, urgency episodes, urgency urinary incontinence (UUI) episodes in the 3-day voiding diary

  3. maximum flow rate (Qmax) [ Time Frame: from baseline to 2 weeks and 4 weeks. ]
    The changes of maximum flow rate (Qmax)

  4. voided volume (Vol) [ Time Frame: from baseline to 2 weeks and 4 weeks. ]
    The changes of voided volume (Vol)

  5. Postvoid residual volume (PVR) [ Time Frame: from baseline to 2 weeks and 4 weeks. ]
    The changes of Postvoid residual volume (PVR)

  6. International Prostate Symptom Score (IPSS) [ Time Frame: from baseline to 2 weeks and 4 weeks. ]
    The changes of International Prostate Symptom Score (IPSS)

  7. quality of life index (QoL-I) [ Time Frame: from baseline to 2 weeks and 4 weeks. ]
    The changes of quality of life index (QoL-I)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male patients with benign prostate hyperplasia (BPH) and undergo transurethral prostatectomy (TURP) or transurethral incision of the prostate (TUIP).
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male patients with BPH and undergo TURP or TUIP.
  2. Patients void smoothly after catheter removal.
  3. No active urinary tract infection.
  4. No gross hematuria or blood clot obstruction.
  5. Patient or his care giver can complete voiding diary and report symptoms.

Exclusion Criteria:

  1. Patients have overt neurological diseases such as cerebrovascular disease, senile dementia or spinal cord injury.
  2. Patients have severe medical disease and completely immobile.
  3. Patients have PVR larger than 150ml.
  4. Patients do not have OAB after TURP.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03632772


Contacts
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Contact: Hann-Chorng Kuo, M.D. 886-3-8561825 ext 12113 hck@tzuchi.com.tw

Locations
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Taiwan
Buddhist Tzu Chi General Hospital Recruiting
Hualien city, Taiwan, 970
Contact: Hann-Chorng Kuo, M.D.    886-3-8561825 ext 2113    hck@tzuchi.com.tw   
Sponsors and Collaborators
Buddhist Tzu Chi General Hospital
Investigators
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Principal Investigator: Hann-Chorng Kuo, M.D. Department of Urology, Buddhist Tzu Chi General Hospital, Hualien

Publications:
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Responsible Party: Hann-Chorng Kuo, Chairman and Professor, Department of Urology, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT03632772     History of Changes
Other Study ID Numbers: TCGH107-115-A
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD was not planned to share.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Hann-Chorng Kuo, Buddhist Tzu Chi General Hospital:
Overactive bladder
Transurethral Resection of the Prostate
Pharmacotherapy
Mirabegron
Solifenacin
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solifenacin Succinate
Mirabegron
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents