Efficacy of Tadalafil/Solifenacin VS Tamsulosin/Solifenacin Combination Therapy for BPH/OAB

Efficacy of Tadalafil and Solifenacin Versus Tamsulosin and Solifenacin Combination Therapy for the Treatment of Benign Prostatic Hyperplasia With Overactive Bladder: A Randomized Controlled Trial

The investigators will compare the efficacy and safety of tadalafil/solifenacin combination therapy versus tamsulosin/solifenacin combination therapy for the treatment of BPH/OAB in a randomized controlled trial (RCT).

Study Overview

• Status: Active, not recruiting
• Conditions: Overactive Bladder; Benign Prostatic Hyperplasia
• Intervention / Treatment: Drug: Tadalafil 5mg; Drug: solifenacin 10 mg; Drug: Tamsulosin Hcl 0.4 mg

Detailed Description

Benign prostatic hyperplasia (BPH) is one of the most commonly diagnosed diseases in aging men worldwide. It is commonly associated with bothersome lower urinary tract symptoms (LUTS) including voiding symptoms such as decreased force of stream, intermittent stream, hesitancy and sensation of incomplete bladder emptying and storage symptoms such as frequent urination, urgency and nocturia. LUTS especially storage symptoms interfere with the daily activities and adversely affect the quality of life (QoL).

Alpha-1 adrenergic receptor blockers have been used as a first-line treatment of LUTS suggestive of BPH (LUTS/BPH). Phosphodiesterase 5 inhibitors (tadalafil) have recently been used as initial treatment of LUTS/BPH. It was confirmed that once daily use of tadalafil 5 mg as a monotherapy is safe and has similar efficacy when compared to tamsulosin.

Combination therapy could be used in patients who have BPH with overactive bladder (BPH/OAB) and still have persistent storage symptoms despite α1- adrenergic blockers. Anticholinergics in combination with α1- adrenergic blockers have been reported to be effective in those patients. Moreover, it has been reported that tadalafil has similar efficacy and safety to solifenacin when used in combination with tamsulosin for patients with persistent storage symptoms refractory to α1- adrenergic blockers. In another study, tadalafil/mirabegron combination therapy was used for BPH/OAB and its effect appeared to be greater than the effect of tadalafil monotherapy. Also, the combination therapy of tadalafil and solifenacin was approved to achieve higher response than tadalafil monotherapy in improvement of persistent storage symptoms associated with BPH.

It was established that tadalafil can be used as a monotherapy to relieve both voiding and storage LUTS and it can be used in combination with tamsulosin or mirabegron to treat BPH/OAB. However, there is limited evidence regarding the efficacy and safety of the combined use of tadalafil and solifenacin for the treatment of BPH/OAB. Therefore, in this study, the investigators will compare the efficacy and safety of tadalafil/solifenacin combination therapy versus tamsulosin/solifenacin combination therapy for the treatment of BPH/OAB in a randomized controlled trial (RCT).

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt, 35516
    • Urology and nephrology center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Ability to give informed consent and reply to questionnaires.
2. Age ≥ 45 years
3. IPSS ≥ 8
4. OABSS ≥ 5, urgency subscore ≥2

Exclusion Criteria:

1. Untreated urinary tract infection (UTI).
2. Postvoid residual (PVR) more than 150 mL
3. Neurogenic lower urinary tract dysfunction (LUTD).
4. Depression or any psychogenic disorders.
5. Diabetes mellitus, hypertension or severe cardiovascular disease.
6. Prior radiation therapy to the pelvic area.
7. Prostate cancer or bladder tumor.
8. Past history of tuberculosis
9. Allergy or contraindication to the used medications
10. Urethral stricture
11. Indwelling urethral catheter
12. Vesical stone.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tadalafil / solifenacin combination therapy; Patients will be treated by combination of Tadalafil 5 mg + solifenacin 10 mg once daily for 12 weeks	Drug: Tadalafil 5mg; patients with BPH/OAB will be treated with combination therapy of tadalafil plus solifenacin for 12 weeks in group 1; Other Names: rectalis 5 mg; Drug: solifenacin 10 mg; patients with BPH/OAB will be treated with combination therapy of tadalafil plus solifenacin in group 1 and tamsulosin plus solifenacin in group 2 for 12 weeks
Active Comparator: Tamsulosin / solifenacin combination therapy; Patients will be treated by combination of Tamsulosin 0.4 mg + solifenacin 10 mg once daily for 12 weeks	Drug: solifenacin 10 mg; patients with BPH/OAB will be treated with combination therapy of tadalafil plus solifenacin in group 1 and tamsulosin plus solifenacin in group 2 for 12 weeks; Drug: Tamsulosin Hcl 0.4 mg; patients with BPH/OAB will be treated with combination therapy of tamsulosin plus solifenacin for 12 weeks in group 2; Other Names: tamsulosin 0.4 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in international prostate symptom score (IPSS) from baseline	Change in IPSS from baseline will be compared. The change of -3 will be estimated as the minimal threshold for a meaningful change. The score has a range from 0 to 35 and higher scores means a worse outcome.	3 months
Change in overactive bladder symptom score (OABSS) from baseline	Change in OABSS from baseline will be compared. The change of -3 will be estimated as the minimal threshold for a meaningful change. The score has a range from 0 to 15 and higher scores means a worse outcome.	3 months
Change in IPSS-quality of life (QoL) score from baseline	Change in IPSS-QoL score from baseline will be compared. It is a single question with a score ranges from 0 to 6 and higher scores means a worse outcome.	3 months
Change in ultrasound measurement of post-void residual urine (PVR) from baseline	Change in PVR from baseline will be compared.	3 months
Change in maximum flow rate (Qmax) from baseline	Change in Qmax from baseline will be compared.	3 months
Adverse effects	Appearance of adverse effects related to the used medications will be reported.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in international index of erectile function-15 (IIEF-15)	change in IIEF-15 in sexually active patients will be compared.	3 months
change in ejaculatory domain of male sexual health questionnaire (Ej-MSHQ)	change in Ej-MSHQ in sexually active patients will be compared.	3 months

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Mohammed Hegazy, Mansoura University; Study Director: Ahmed Elhefnawy, Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2021
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: August 7, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 10, 2022

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Benign Prostatic Hyperplasia; Overactive Bladder; tadalafil; combination therapy for BPH
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Prostatic Diseases; Urinary Bladder, Overactive; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tadalafil; Tamsulosin; Solifenacin Succinate
• Other Study ID Numbers: Tadalafil for BPH/OAB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No