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

NCT03632772 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: TCGH107-115-A
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder Syndrome

Keywords

Overactive bladder; Transurethral Resection of the Prostate; Pharmacotherapy; Mirabegron; Solifenacin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Overactive Bladder Symptom Score (OABSS)

  from baseline to 2 weeks and 4 weeks.

• 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)

  from baseline to 2 weeks and 4 weeks.

• voided volume (Vol)

  from baseline to 2 weeks and 4 weeks.

• Postvoid residual volume (PVR)

  from baseline to 2 weeks and 4 weeks.

Study Arms (3)

Solifenacin 5 mg for 4 weeks

EXPERIMENTAL

Solifenacin 5 mg once-daily for 4 weeks.

Drug: Solifenacin 5Mg

Mirabegron 50 mg for 4 weeks

EXPERIMENTAL

Mirabegron 50 mg once-daily for 4 weeks.

Drug: Mirabegron 50 MG

Control: non treatment

NO INTERVENTION

Control: non treatment.

Interventions

Solifenacin 5Mg DRUG

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.

Also known as: Vesicare

Solifenacin 5 mg for 4 weeks

Mirabegron 50 MG DRUG

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.

Also known as: Betmiga

Mirabegron 50 mg for 4 weeks

Eligibility Criteria

• Age: 20 Years - 80 Years
• Gender Eligibility Details: Male patients with benign prostate hyperplasia (BPH) and undergo transurethral prostatectomy (TURP) or transurethral incision of the prostate (TUIP).
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Buddhist Tzu Chi General Hospital

Hualien City, 970, Taiwan

RECRUITING

Related Publications (6)

• 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.

  PMID: 18973143 BACKGROUND

• 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.

  PMID: 29709423 BACKGROUND

• Kelleher C, Hakimi Z, Zur R, Siddiqui E, Maman K, Aballea 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.

  PMID: 29699858 BACKGROUND

• 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.

  PMID: 27619782 BACKGROUND

• Nitti VW, Rosenberg S, Mitcheson DH, He W, Fakhoury A, Martin NE. Urodynamics and safety of the beta(3)-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.

  PMID: 23727415 BACKGROUND

• Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.

  PMID: 37160401 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Solifenacin Succinate; mirabegron

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hann-Chorng Kuo, M.D.

  Department of Urology, Buddhist Tzu Chi General Hospital, Hualien

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hann-Chorng Kuo, M.D.

CONTACT

886-3-8561825; hck@tzuchi.com.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman and Professor, Department of Urology

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 15, 2018
• Study Start: August 1, 2018
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: August 24, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)