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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

Tracking Information
First Submitted Date  ICMJE August 13, 2018
First Posted Date  ICMJE August 15, 2018
Last Update Posted Date August 24, 2018
Actual Study Start Date  ICMJE August 1, 2018
Estimated Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03632772 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2018)
  • Overactive Bladder Symptom Score (OABSS) [ Time Frame: from baseline to 2 weeks and 4 weeks. ]
    The changes of OABSS
  • 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
  • maximum flow rate (Qmax) [ Time Frame: from baseline to 2 weeks and 4 weeks. ]
    The changes of maximum flow rate (Qmax)
  • voided volume (Vol) [ Time Frame: from baseline to 2 weeks and 4 weeks. ]
    The changes of voided volume (Vol)
  • Postvoid residual volume (PVR) [ Time Frame: from baseline to 2 weeks and 4 weeks. ]
    The changes of Postvoid residual volume (PVR)
  • International Prostate Symptom Score (IPSS) [ Time Frame: from baseline to 2 weeks and 4 weeks. ]
    The changes of International Prostate Symptom Score (IPSS)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Solifenacin and Mirabegron in Treatment of Overactive Bladder Symptoms in Men After TURP
Official Title  ICMJE Comparative Study of Solifenacin and Mirabegron in Treatment of Overactive Bladder Symptoms in Men After Transurethral Resection of the Prostate - A Randomized Prospective Study
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Overactive Bladder Syndrome
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Solifenacin 5 mg for 4 weeks
    Solifenacin 5 mg once-daily for 4 weeks.
    Intervention: Drug: Solifenacin 5Mg
  • Experimental: Mirabegron 50 mg for 4 weeks
    Mirabegron 50 mg once-daily for 4 weeks.
    Intervention: Drug: Mirabegron 50 MG
  • No Intervention: Control: non treatment
    Control: non treatment.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 14, 2018)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2019
Estimated Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
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).
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hann-Chorng Kuo, M.D. 886-3-8561825 ext 12113 hck@tzuchi.com.tw
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03632772
Other Study ID Numbers  ICMJE TCGH107-115-A
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: IPD was not planned to share.
Responsible Party Hann-Chorng Kuo, Buddhist Tzu Chi General Hospital
Study Sponsor  ICMJE Buddhist Tzu Chi General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hann-Chorng Kuo, M.D. Department of Urology, Buddhist Tzu Chi General Hospital, Hualien
PRS Account Buddhist Tzu Chi General Hospital
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP