A retrospective study of clinical outcomes of α-blocker or finasteride monotherapy followed by combination therapy: determination of the period of combination therapy of α-blocker and finasteride

Son, Heejung; Cho, S. Y.; Park, S.; Kang, Jung Yoon; Kim, C. S.; Kim, H. G.

doi:10.1111/ijcp.12045

Cited by 5 publications

(7 citation statements)

References 18 publications

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“…The best effect in reducing the progression of BPH is seen in PV > 35mL and PSA > 2.0 ng/mL 25 . Symptoms improved by combination therapy and maintained after discontinuation of AB and continuous administration of 5-ARI monotherapy, whereas the risk of urinary retention due to the re-growth of the prostate is reduced 26 .…”

Section: Discussionmentioning

confidence: 98%

Impact of pharmacologic therapy for benign prostatic hyperplasia on prostate volume and free testosterone and consequently on urinary parameters and sexual desire in men

et al. 2017

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Background/Aim. Pharmacologic therapy for benign prostatic hyperplasia (BPH) relieves disease progression and affects the androgen hormone status. A decrease in the level of free testosterone (freeT) within total testosterone (totalT) leads to symptoms of sexual dysfunction. The aim of this study was to show the impact of pharmacological treatment for BPH on prostate volume (PV) and levels of freeT and, consequently, on urinary parameters and sexual desire in men during 6 months of administration. Methods. This clinical prospective study included 156 BPH patients with moderate urinary symptoms-International Prostate Symptom Score (IPSS) < 19, PV > 30 mL and prostate specific antigen (PSA) value < 4 ng/mL. The average age of patients was 61.16 ± 2.97 years. The performed tests included determination of tumor markers (PSA, free PSA), hormones (totalT, freeT, freeT/totalT ratio), trans abdominal ultrasonography and uroflowmetry. Urinary symptoms were measured by IPSS and the Quality of Life (QoL) questionnaire while the changes in sexual desire were measured using the International Index of Erectile Function (IIEF) questionnaire. Four groups were formed, 39 patients each. The group 1 received alpha1blocker (AB) tamsulosin, the group 2, 5 alpha-reductase inhibitor (5-ARI) finasteride, the group 3, combined therapy of both drugs (tamsulosin and finasteride), while the group 4 (control group) had no therapy. Follow-ups were performed every three and six months during therapy administration. Results. Prostate volume significantly decreased in the patients on combined therapy (-6.95 ± 2.00; p < 0.001) and finasteride (-6.67 ± 3.35). In the finasteride group, the levels of freeT (-4.23 ± 5.2; p < 0.001) and freeT/totalT ratio (-0.12 0.08; p < 0.001) significantly decreased as did the freeT (-2.64 ± 7.81) and freeT/totalT ratio (-0.09 ± 0.13) in the combined therapy group. Uroflowmetry showed a significant improvement in all parameters and all the therapy groups. Combined therapy provided the greatest improvement in the maximum flow rate (Qmax) (+4.06 ± 1.75; p < 0.001) and urinary symptoms (-10.95 ± 3.19). A significant improvement of sexual desire occurred in the patients on tamsulosin (+0.78 ± 1.00; p < 0.001), with a slight deterioration in the finasteride group, but without statistical significance. Conclusion. Hormonal component of pharmacologic therapy for BPH most effectively reduces PV and freeT levels, improves urinary symptoms with a slight decline of sexual desire in men on finasteride monotherapy.

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Section: Discussionmentioning

confidence: 98%

Impact of pharmacologic therapy for benign prostatic hyperplasia on prostate volume and free testosterone and consequently on urinary parameters and sexual desire in men

et al. 2017

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“…Among 33 men who initially experienced symptomatic improvement with α 1 -blocker monotherapy, mean symptom severity were not increased up to 6 months after unblinded discontinuation and more than two-thirds of men remained off medication (39). Another unblinded study among 75 men with symptomatic improvement after α 1 -blocker monotherapy demonstrated stable symptoms for up to 12 months after discontinuation with only 30% of men requesting re-initiation of treatment (40). Even among men with more severe LUTS who are treated with combined α 1 -blockers plus 5α-reductase inhibitor therapy, both observational and randomized studies have demonstrated no symptomatic progression in the majority of men who discontinue α 1 -blockers but continue 5α-reductase inhibitor monotherapy (41-44).…”

Section: Discussionmentioning

confidence: 99%

“…Another unblinded study among 75 men with symptomatic improvement after α 1 -blocker monotherapy demonstrated stable symptoms for up to 12 months after discontinuation with only 30% of men requesting re-initiation of treatment ( 40 ). Even among men with more severe LUTS who are treated with combined α 1 -blockers plus 5α-reductase inhibitor therapy, both observational and randomized studies have demonstrated no symptomatic progression in the majority of men who discontinue α 1 -blockers but continue 5α-reductase inhibitor monotherapy ( 41 – 44 ). In the largest randomized clinical trial of 230 men receiving combined therapy who were assigned to discontinue either 5α-reductase inhibitor or α 1 -blocker, 74% of men in both groups had no worsening of symptoms after 12 months ( 45 ).…”

Section: Discussionmentioning

confidence: 99%

PERSONAL: Feasibility Study Protocol for Placebo-Controlled, Randomized n-of-1 Trials of Tamsulosin for Lower Urinary Tract Symptoms

Bauer¹,

Breyer²,

Oni‐Orisan³

et al. 2020

Front. Digit. Health

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Background: Lower urinary tract symptoms (LUTS) affect more than half of men over age 70 and contribute to both poor health-related quality of life and polypharmacy. Tamsulosin hydrochloride, a selective α 1-blocker, is the most common medication used to treat LUTS due to presumed benign prostatic hyperplasia and is often prescribed indefinitely, although not all men benefit from long-term therapy. N-of-1 trials allow for individualized estimates of benefit and harm and could facilitate decisions regarding chronic tamsulosin therapy for LUTS, particularly among older men. Our team developed the PERSONAL (PlacEbo-controlled, Randomized, patient-Selected Outcomes, N-of-1 triALs) app to track daily urinary symptoms and medication side effects for n-of-1 trials among older men with LUTS. Materials and Methods: We will conduct a feasibility study of 20 individual randomized n-of-1 trials using the PERSONAL app to compare tamsulosin (0.4 or 0.8 mg) vs. placebo among older men taking tamsulosin for LUTS. We will include men over age 65 with a smartphone for whom temporary discontinuation of tamsulosin is safe, (e.g., no history of acute retention). Participants will work with research staff to prospectively identify the most important urinary symptoms and medication side effects that they would like to digitally track. Men will then be randomized to 2-week treatment periods of tamsulosin or placebo followed by a 1-week wash-out with placebo, for 4 distinct treatment periods and 3 wash-out periods, totaling 11 weeks. Study medications will be blinded using over-encapsulation of tamsulosin pills and matching placebo. Our primary outcomes for this study will be recruitment and retention of eligible men, completion rates of n-of-1 trials and daily questionnaires using the PERSONAL app, and participants' perceived usefulness of their n-of-1 trial for determining whether tamsulosin is effective for them. Linear mixed effects models with individual-specific intercepts and intervention effects will also be used to estimate within-individual effects of tamsulosin. Bauer et al. PERSONAL: n-of-1 for Urinary Symptoms Discussion: The goal of this innovative study is to establish feasibility and acceptability of using a mobile health app and n-of-1 trials to provide older men with individualized estimates of benefits and harms of chronic tamsulosin therapy for LUTS.

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“…Some interventions to improve TWOC outcomes, such as medication, often require long periods of time to take full effect (Fisher et al 2014;Joint Formulary Committee 2022). Patients can become unhappy and frustrated with their indwelling catheter and may request their TWOC takes place sooner, not allowing for the full effectiveness of the intervention to take place (Son et al 2013;Vlotman-Novinuk 2019). This could cause another failed TWOC.…”

Section: Other Benefits Of Catheter Valvesmentioning

confidence: 99%

Catheter valves: are they useful in supporting patients in a trial without catheter?

McNaughton

Fairley-Murdoch

2022

Br J Community Nurs

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A trial without catheter (TWOC) is a common urological procedure undertaken to remove an indwelling urinary catheter when no longer clinically indicated. An appropriately trained practitioner should undertake a TWOC in a controlled environment to ensure that a further urinary retention does not occur. Indwelling urinary catheters are commonly used with a free drainage system such as a leg bag, which continually empties the bladder. This article examines the potential benefits of using a catheter valve as an alternative to free drainage, prior to undertaking a TWOC, to optimise clinical outcomes and patient experience. This article will guide nurses to increase their knowledge of catheter valves to promote person-centred informed decision-making.

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A retrospective study of clinical outcomes of α-blocker or finasteride monotherapy followed by combination therapy: determination of the period of combination therapy of α-blocker and finasteride

Abstract: Discontinuation of alpha-blockers or finasteride after combination therapy for ≥ 6 months maintained improvements in symptoms. The appropriate period of combination therapy was ≥ 9 months.

Cited by 5 publications

References 18 publications

Impact of pharmacologic therapy for benign prostatic hyperplasia on prostate volume and free testosterone and consequently on urinary parameters and sexual desire in men

Impact of pharmacologic therapy for benign prostatic hyperplasia on prostate volume and free testosterone and consequently on urinary parameters and sexual desire in men

PERSONAL: Feasibility Study Protocol for Placebo-Controlled, Randomized n-of-1 Trials of Tamsulosin for Lower Urinary Tract Symptoms

Catheter valves: are they useful in supporting patients in a trial without catheter?

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