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

August 23, 2018 updated by: Hann-Chorng Kuo, Buddhist Tzu Chi General Hospital

Comparative Study of Solifenacin and Mirabegron in Treatment of Overactive Bladder Symptoms in Men After Transurethral Resection of the Prostate - A Randomized Prospective Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

  • Name: Hann-Chorng Kuo, M.D.
  • Phone Number: 12113 886-3-8561825
  • Email: hck@tzuchi.com.tw

Study Locations

  • Taiwan
      • Hualien city, Taiwan, 970
        • Recruiting
        • Buddhist Tzu Chi General Hospital

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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

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: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Betmiga
No Intervention: Control: non treatment
Control: non treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from baseline to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overactive Bladder Symptom Score (OABSS)
Time Frame: from baseline to 2 weeks and 4 weeks.
The changes of OABSS
from baseline to 2 weeks and 4 weeks.
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
from baseline to 2 weeks and 4 weeks.
maximum flow rate (Qmax)
Time Frame: from baseline to 2 weeks and 4 weeks.
The changes of maximum flow rate (Qmax)
from baseline to 2 weeks and 4 weeks.
voided volume (Vol)
Time Frame: from baseline to 2 weeks and 4 weeks.
The changes of voided volume (Vol)
from baseline to 2 weeks and 4 weeks.
Postvoid residual volume (PVR)
Time Frame: from baseline to 2 weeks and 4 weeks.
The changes of Postvoid residual volume (PVR)
from baseline to 2 weeks and 4 weeks.
International Prostate Symptom Score (IPSS)
Time Frame: from baseline to 2 weeks and 4 weeks.
The changes of International Prostate Symptom Score (IPSS)
from baseline to 2 weeks and 4 weeks.
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)
from baseline to 2 weeks and 4 weeks.

Collaborators and Investigators

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

Sponsor

Buddhist Tzu Chi General Hospital

Investigators

  • Principal Investigator: Hann-Chorng Kuo, M.D., Department of Urology, Buddhist Tzu Chi General Hospital, Hualien

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

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)

August 1, 2018

Primary Completion (Anticipated)

July 31, 2019

Study Completion (Anticipated)

July 31, 2019

Study Registration Dates

First Submitted

August 13, 2018

First Submitted That Met QC Criteria

August 14, 2018

First Posted (Actual)

August 15, 2018

Study Record Updates

Last Update Posted (Actual)

August 24, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCGH107-115-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IPD was not planned to share.

Drug and device information, study documents

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

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.

Clinical Trials on Overactive Bladder Syndrome

Clinical Trials on Solifenacin 5Mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe