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Efficacy of a combination of dutasteride, tadalafil, and solifenacin in the treatment of previously unsuccessful patients |
Kirill Kosilova,b,*( ),Irina Kuzinaa,Vladimir Kuznetsovc,Olga Barabashd,Ekaterina Fedorishchevac
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a Department of Social Sciences, School of Humanities, Far Eastern Federal University, Vladivostok, Primorsky region, Russian Federation b Department of Clinical Medicine, School of Medicine, Far Eastern Federal University, Vladivostok, Primorsky region, Russian Federation c Department of Public Health, Pacific State Medical University, Vladivostok, Primorsky region, Russian Federation d Department of Physical Culture and Health and Sports Work, Vladivostok State University of Economics and Service, Vladivostok, Primorsky region, Russian Federation |
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Abstract Objective: To evaluate the efficacy and safety of simultaneous administration of dutasteride, tadalafil and solifenacin in the treatment of benign prostatic hyperplasia (BPH) with overactive bladder symptoms and lower urinary tract obstruction in previously unsuccessfully treated men. Methods: Patients in Group A (n=97) received dutasteride 0.5 mg/day, tadalafil 2.5 mg/day, and solifenacin 2.5 mg/day; Group B (n=95) received dutasteride 0.5 mg/day, tadalafil 5 mg/day, and solifenacin 5 mg/day; Group C (n=103) received dutasteride 0.5 mg/day, tadalafil 20 mg/day, and solifenacin 10 mg/day. The functional status of the lower urinary tract was assessed using the International Prostate Symptom Score (I-PSS), Overactive Bladder Questionnaire (OABq), International Index of Erectile Function (IIEF), and Male Sexual Health Questionnaire Ejaculatory Dysfunction (MSHQ-EjD) as well as uroflowmetry. Results: The total score of the sexual function remained unchanged in Group B of patients 81.3 points vs. 80.2 points (p>0.05) according to MSHQ-EjD, 61.4 points vs. 51.2 points (p>0.05) according to IIEF data. The total assessment of symptoms of hyperactivity significantly decreased in Group C according to OABq data after the 4th week of the study (17.5 points vs. 26.1 points, p<0.05) and remained below the baseline until the end of the study (15.2 points). Conclusions: The simultaneous administration of standard doses of dutasteride, solifenacin, and tadalafil for 3 months is safe, effective, and can be recommended for patients with BPH to reduce symptoms of obstruction and hyperactivity of the bladder and maintain sexual function.
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Received: 08 July 2019
Available online: 20 January 2022
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Corresponding Authors:
Kirill Kosilov
E-mail: oton2000@mail.ru
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Variable | Group A (n=97) | Group B (n=95) | Group C (n=103) | Age, mean (SD), year | 62.3 (10.5) | 66.4 (12.4) | 67.3 (14.2) | Married, n (%) | 61 (62.9) | 73 (76.8) | 70 (68.0) | Professionally active, n (%) | 35 (36.1) | 45 (47.4) | 32 (31.1) | City areas, n (%) | 78 (80.4) | 57 (60.0) | 68 (66.0) | Education, n (%) | Secondary | 19 (19.6) | 17 (17.9) | 13 (12.6) | Vocational | 31 (32.0) | 17 (17.9) | 34 (33.0) | Higher | 47 (48.4) | 61 (64.2) | 56 (54.4) | Experience of taking, n (%) | α1-AB (monotherapy) | 34 (35.1) | 19 (20.0) | 21 (20.4) | 5-ARIs (monotherapy) | 14 (14.4) | 25 (26.3) | 31 (30.1) | PDE5-Is (monotherapy) | 9 (9.3) | 14 (14.7) | 18 (17.5) | AM (monotherapy) | 45 (46.4) | 64 (67.4) | 42 (40.8) | Various of combinations | 19 (19.6) | 27 (28.4) | 58 (56.3) | MSHQ-EjD score sum, mean (SD) | 75.8 (9.1) | 80.2 (11.4) | 68.5 (5.9) | IIEF score sum, mean (SD) | 55.2 (7.1) | 51.2 (7.8) | 47.3 (8.8) | Prostate volume, mean (SD), mL | 44.5 (5.5) | 39.8 (7.4) | 38.9 (7.7) | Level of PSA, mean (SD), ng/mL | 3.7 (2.1) | 4.2 (1.4) | 4.6 (1.2) | Uroflowmetry, mean (SD) | PVR, mL | 46.9 (7.6) | 50.3 (12.1) | 42.4 (8.5) | Qaver, mL/s | 9.1 (2.7) | 9.5 (2.6) | 8.9 (1.7) | Qmax, mL/s | 13.0 (3.4) | 12.3 (5.0) | 12.1 (2.4) | I-PSS score sum, mean (SD) | 20.4 (4.5) | 21.0 (3.5) | 22.1 (3.8) | OABq-AT score sum, mean (SD) | 25.6 (5.4) | 28.7 (3.6) | 26.1 (5.2) | Diary of voiding, mean (SD) | Daytime frequency, episodes | 9.7 (1.5) | 8.8 (0.7) | 9.2 (1.3) | Nighttime frequency, episodes | 2.4 (1.4) | 2.1 (1.0) | 2.3 (0.9) | Urgency, episodes | 1.7 (0.7) | 1.9 (0.4) | 1.9 (0.5) | Incontinence, episodes | 0.4 (0.4) | 0.4 (0.2) | 0.3 (0.2) |
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Physiological and socio-demographic characteristics in men with benign prostatic hyperplasia and lower urinary tract symptoms (n=295).
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Study design (n=295). USoPG, ultrasound examination of the prostate gland; PSA, prostatic-specific antigen; I-PSS, International Prostate Symptom Score; OAB-AT, Overactive Bladder Awareness Tool; MSHQ-EjD, Men's Sexual Health Questionnaire Ejaculatory Dysfunction; IIEF, the International Index of Erectile Function; UF, uroflowmetry.
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Symptoms of obstruction lower urinary tract in patients with benign prostate hyperplasia before and after treatment (n=295). (A) I-PSS before/after treatment, total score; (B) UF before/after treatment, Qaver, mL/s. I-PSS, International Prostate Symptom Score; UF, uroflowmetry. ? Differences are statistically significant.
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Symptoms of hyperactive lower urinary tract in patients with benign prostate hyperplasia before and after treatment (n=295; Group A: n=95; Group B: n=97; Group C: n=103). (A) OAB-questionnaire overall rating; (B) Voiding diaries, number of episodes. OAB, overactive bladder. ? Differences are statistically significant.
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Symptoms of sexual dysfunction in patients with benign prostate hyperplasia before and after treatment (n = 295; Group A: n = 95; Group B: n = 97; Group C: n = 103). (A) The results according to the Men's Sexual Health Questionnaire; (B) The results according to the International Index of Erectile Function. ? Differences are statistically significant.
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