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

Sponsor
Mansoura University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05494567
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
8.7
Anticipated Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Tadalafil 5mg
  • Drug: Tamsulosin Hcl 0.4 mg
  • Drug: solifenacin 10 mg
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 8, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

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: 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

    • 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

    Outcome Measures

    Primary Outcome Measures

    1. Change in international prostate symptom score (IPSS) from baseline [3 months]

      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.

    2. Change in overactive bladder symptom score (OABSS) from baseline [3 months]

      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. Change in IPSS-quality of life (QoL) score from baseline [3 months]

      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.

    4. Change in ultrasound measurement of post-void residual urine (PVR) from baseline [3 months]

      Change in PVR from baseline will be compared.

    5. Change in maximum flow rate (Qmax) from baseline [3 months]

      Change in Qmax from baseline will be compared.

    6. Adverse effects [3 months]

      Appearance of adverse effects related to the used medications will be reported.

    Secondary Outcome Measures

    1. change in international index of erectile function-15 (IIEF-15) [3 months]

      change in IIEF-15 in sexually active patients will be compared.

    2. change in ejaculatory domain of male sexual health questionnaire (Ej-MSHQ) [3 months]

      change in Ej-MSHQ in sexually active patients will be compared.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Urology and Nephrology center Mansoura Egypt 35516

    Sponsors and Collaborators

    • Mansoura University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mohammed Hegazy, principal investigator, Mansoura University
    ClinicalTrials.gov Identifier:
    NCT05494567
    Other Study ID Numbers:
    • Tadalafil for BPH/OAB
    First Posted:
    Aug 10, 2022
    Last Update Posted:
    Aug 10, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mohammed Hegazy, principal investigator, Mansoura University
    Benign Prostatic Hyperplasia
    Overactive Bladder
    tadalafil
    combination therapy for BPH
    Additional relevant MeSH terms:
    Urinary Bladder, Overactive
    Prostatic Hyperplasia
    Hyperplasia
    Tadalafil
    Tamsulosin
    Solifenacin Succinate

    Study Results

    No Results Posted as of Aug 10, 2022