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

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05494567
• Other study ID #: Tadalafil for BPH/OAB
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: November 8, 2021
• Est. completion date: August 2022

Study information

• Verified date: August 2022
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Overactive Bladder
• Prostatic Hyperplasia
• Urinary Bladder, Overactive

Intervention

Drug:
• Tadalafil 5mg
patients with BPH/OAB will be treated with combination therapy of tadalafil plus solifenacin for 12 weeks in group 1
• 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
• 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

Locations

Country	Name	City	State
Egypt	Urology and Nephrology center	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Change in ultrasound measurement of post-void residual urine (PVR) from baseline	Change in PVR from baseline will be compared.	3 months
Primary	Change in maximum flow rate (Qmax) from baseline	Change in Qmax from baseline will be compared.	3 months
Primary	Adverse effects	Appearance of adverse effects related to the used medications will be reported.	3 months
Secondary	change in international index of erectile function-15 (IIEF-15)	change in IIEF-15 in sexually active patients will be compared.	3 months
Secondary	change in ejaculatory domain of male sexual health questionnaire (Ej-MSHQ)	change in Ej-MSHQ in sexually active patients will be compared.	3 months