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

Overactive Bladder Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03632772
• Other study ID #: TCGH107-115-A
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: August 2018
• Source: Buddhist Tzu Chi General Hospital
• Contact: Hann-Chorng Kuo, M.D.
• Phone: 886-3-8561825
• Email: hck[@]tzuchi.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overactive Bladder Syndrome
• Urinary Bladder, Overactive

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	Buddhist Tzu Chi General Hospital	Hualien city

Sponsors (1)

Lead Sponsor	Collaborator
Buddhist Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

Kelleher C, Hakimi Z, Zur R, Siddiqui E, Maman K, Aballéa S, Nazir J, Chapple C. Efficacy and Tolerability of Mirabegron Compared with Antimuscarinic Monotherapy or Combination Therapies for Overactive Bladder: A Systematic Review and Network Meta-analysis. Eur Urol. 2018 Sep;74(3):324-333. doi: 10.1016/j.eururo.2018.03.020. Epub 2018 Apr 23. — View Citation

Nitti VW, Rosenberg S, Mitcheson DH, He W, Fakhoury A, Martin NE. Urodynamics and safety of the ß3-adrenoceptor agonist mirabegron in males with lower urinary tract symptoms and bladder outlet obstruction. J Urol. 2013 Oct;190(4):1320-7. doi: 10.1016/j.juro.2013.05.062. Epub 2013 May 30. — View Citation

Seki N, Yuki K, Takei M, Yamaguchi A, Naito S. Analysis of the prognostic factors for overactive bladder symptoms following surgical treatment in patients with benign prostatic obstruction. Neurourol Urodyn. 2009;28(3):197-201. doi: 10.1002/nau.20619. — View Citation

Wada N, Iuchi H, Kita M, Hashizume K, Matsumoto S, Kakizaki H. Urodynamic Efficacy and Safety of Mirabegron Add-on Treatment with Tamsulosin for Japanese Male Patients with Overactive Bladder. Low Urin Tract Symptoms. 2016 Sep;8(3):171-6. doi: 10.1111/luts.12091. Epub 2015 Feb 17. — View Citation

Yamada S, Ito Y, Nishijima S, Kadekawa K, Sugaya K. Basic and clinical aspects of antimuscarinic agents used to treat overactive bladder. Pharmacol Ther. 2018 Sep;189:130-148. doi: 10.1016/j.pharmthera.2018.04.010. Epub 2018 Apr 27. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urgency Severity Scale (USS)	The change of USS from baseline to 4 weeks after catheter removal and starting OAB medication.	from baseline to 4 weeks
Secondary	Overactive Bladder Symptom Score (OABSS)	The changes of OABSS	from baseline to 2 weeks and 4 weeks.
Secondary	frequency episodes, urgency episodes, urgency urinary incontinence (UUI) episodes in the 3-day voiding diary	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.
Secondary	maximum flow rate (Qmax)	The changes of maximum flow rate (Qmax)	from baseline to 2 weeks and 4 weeks.
Secondary	voided volume (Vol)	The changes of voided volume (Vol)	from baseline to 2 weeks and 4 weeks.
Secondary	Postvoid residual volume (PVR)	The changes of Postvoid residual volume (PVR)	from baseline to 2 weeks and 4 weeks.
Secondary	International Prostate Symptom Score (IPSS)	The changes of International Prostate Symptom Score (IPSS)	from baseline to 2 weeks and 4 weeks.
Secondary	quality of life index (QoL-I)	The changes of quality of life index (QoL-I)	from baseline to 2 weeks and 4 weeks.