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

NCT05494567 | Unknown Phase 4

• 1 other identifier: Tadalafil for BPH/OAB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Benign Prostatic Hyperplasia; Overactive Bladder

Keywords

Benign Prostatic Hyperplasia; Overactive Bladder; tadalafil; combination therapy for BPH

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• change in international index of erectile function-15 (IIEF-15)

  3 months

• change in ejaculatory domain of male sexual health questionnaire (Ej-MSHQ)

  3 months

Study Arms (2)

Tadalafil / solifenacin combination therapy

ACTIVE COMPARATOR

Patients will be treated by combination of Tadalafil 5 mg + solifenacin 10 mg once daily for 12 weeks

Drug: Tadalafil 5mg; Drug: solifenacin 10 mg

Tamsulosin / solifenacin combination therapy

ACTIVE COMPARATOR

Patients will be treated by combination of Tamsulosin 0.4 mg + solifenacin 10 mg once daily for 12 weeks

Drug: Tamsulosin Hcl 0.4 mg; Drug: solifenacin 10 mg

Interventions

Tadalafil 5mg DRUG

patients with BPH/OAB will be treated with combination therapy of tadalafil plus solifenacin for 12 weeks in group 1

Also known as: rectalis 5 mg

Tadalafil / solifenacin combination therapy

Tamsulosin Hcl 0.4 mg DRUG

patients with BPH/OAB will be treated with combination therapy of tamsulosin plus solifenacin for 12 weeks in group 2

Also known as: tamsulosin 0.4 mg

Tamsulosin / solifenacin combination therapy

solifenacin 10 mg DRUG

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

Tadalafil / solifenacin combination therapy; Tamsulosin / solifenacin combination therapy

Eligibility Criteria

• Age: 45 Years+
• Gender Eligibility Details: Patients suffering from BPH/OAB will be asked to participate in this study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology center

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Urinary Bladder, Overactive

Interventions

Tadalafil; Tamsulosin; Solifenacin Succinate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Tetrahydroisoquinolines; Isoquinolines

Study Officials

• Mohammed Hegazy

  Mansoura University

  PRINCIPAL INVESTIGATOR

• Ahmed Elhefnawy

  Mansoura University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 7, 2022
• First Posted: August 10, 2022
• Study Start: November 8, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

EG (1)