Benign Prostatic Hyperplasia: Drug Therapy

Supplements (dietary supplements; vital substances)

Appropriate dietary supplements should contain the following vital substances:

Note: The listed vital substances are not a substitute for drug therapy. Food supplements are intended to supplement the general diet in the particular life situation.

Therapy target

Improvement of lower urinary tract symptoms (LUTS) symptomatology/symptoms.

Therapy recommendations

  • Conservative therapy may be used if there is no clinically relevant obstruction (BOO, English : bladder outlet obstruction/) or BPH-related complications (see “Surgical therapy” for details).
  • Drug therapy as monotherapy:
    • Selective alpha-1-adrenoceptor antagonists (α1-adrenoceptor antagonists; α1-blockers): improve bladder emptying and urinary flow; have little or no effect on BPO (Engl. benign prostatic obstruction), but are useful for symptom reduction (reduce IPSS by 1-4 points compared with placebo) and symptomatic progression inhibition (inhibit progression) in patients with BPH (benign prostatic syndrome) (“evidence” level 1a, recommendation grade A).
    • 5-Alpha reductase inhibitors (5ARIs): reduction of prostate size or inhibition of symptom progression; suitable for symptom reduction and progression inhibition in patients with BPE (benign prostate enlargement: > 30-40 ml) and for progression inhibition in planned long-term therapy (> 1 year). However, the degree of obstruction does not change significantly during therapy with 5-alpha-reductase inhibitors (“evidence” level 1a, recommendation grade A). Note: There is a 21% increased risk of high-grade prostate cancer after more than two years of therapy with a 5-alpha reductase inhibitor.
    • Muscarinic receptor antagonists can be used treatment of bladder storage symptoms:
      • For imperative urination (urge to urinate that cannot be suppressed or controlled), urge incontinence (strong urge to urinate), and increased micturition frequency (OAB symptoms) (“evidence” level 1a, recommendation grade A).
      • To reduce the number of nocturnal micturitions / urination (nocturia) (“evidence” level 1a, recommendation grade A).
    • Phosphodiesterase inhibitors (PDE5 inhibitors) may be used:
      • To improve symptomatology in men with moderate and severe lower urinary tract symptoms (LUTS) with or without erectile dysfunction (ED) (“evidence” level 1a, recommendation grade A) Tadafil (5 mg/d) results in improvement in subjective parameters (IPSS) and objective parameters (Q max)
      • PDE5 inhibitors (data for tadalafil only) have no effect on BOO.
    • Β3-Agonists (Mirabegon): to reduce irritative bladder storage symptoms.
  • Combination therapy:
    • Combination therapy with α1-blockers and 5α-reductase inhibitors should be offered to patients with BPD with moderate/expressed symptoms and increased risk of progression (prostate volume > 30-40 ml, Q max < 15 ml/s); recommended only as a long-term therapeutic approach ( > 1 year) (“evidence” level 1a, recommendation grade A).
    • Combination therapy with an α1-blocker and muscarinic receptor antagonist is significantly more effective than single agents in reducing LUTS (IPSS) and improving quality of life; acts independently of prostate volume (serum PSA concentration as surrogate parameter) (“Evidence” level 1a, recommendation grade A)
      • Residual urine volume increases slightly; however, the risk of (acute) ischuria (urinary retention) and the need for bladder catheterization are not increased
      • Has only a minor effect on the BOO
      • Dry mouth occurs significantly more often than with placebos or α1-blocker monotherapy
    • Combination therapy with a PDE5 inhibitor and α1-blocker suggests a beneficial effect on symptomatology, but studies are inconsistent (“evidence” level 1, recommendation grade A)
  • Phytotherapeutics (herbal medicines) with β-sitosterol-containing preparations as complementary medicine therapy to improve minor to moderate symptoms; have no influence on a BOO; no conclusive general recommendations can be made.

Wg. Therapy of overactive bladder (OAB, overactive bladder), urge incontinence, urge symptomatology: Mirabegron (beta-3-adrenoceptor agonists) – see below Urinary incontinence/Medicinal therapy (Note: Mirabegron is currently (since June 1, 2015) not available in Germany. This is due to a disagreement between the GKV-Spitzenverband and the manufacturing company within the framework of the Arzneimittelmarkt-Neuordnungsgesetz (AMNOG). The market withdrawal only affects Germany. It can be obtained as an individual import via pharmacies within the framework of self-payment). Note: FORTA classification (Drugs for the Oral Treatment of LUTS/Lower Urinary Tract Symptoms; modified from):

  • Category A: essential drug; clear benefit in terms of efficacy and safety in the elderly patient: no drugs identified.
  • Category B: drugs with established effectiveness for a specific indication in the elderly, but limited effect or limited safety: dutasteride, finasteride, fesoterodine.
  • Category C: drugs with questionable or limited safety/tolerability in the elderly patient (to be avoided when using too many other drugs; use of alternative drugs recommended): Darifenacin, mirabegon, “extended-release” oxybutynin, solifenacin, tolterodine, trospium chloride, silodosin, tadalafil, tamsulosin.
  • Category D: Drugs that have no demonstrable benefit or dangerous side effects in the elderly patient and should be omitted first; use of alternative drugs strongly recommended: Alfuzosin, doxazosin, “immediate-release” oxybutynin, propiverine, terasozin.

Other notes

  • After prostatectomy, therapy with a PDE-5 inhibitor may increase the risk of biochemical recurrence (4,752 patients; 84.7% vs 89.2%)
  • Post-finasteride syndrome (PFS): symptoms that persisted for at least 3 months after discontinuation of treatment for androgenetic alopecia with 1 mg finasteride
    • Somatic symptoms
      • Gynecomastia, lethargy, fatigue, muscle atrophy, increased fat storage, loss of libido, erectile dysfunction, and depression; orgasmic disturbances,
    • Cognitive disorders
      • Severe memory loss, slow thought process
    • Mental disorders
      • Increased anxiety, affect inhibition, emotional lability, sleep disturbances, insomnia, suicidal ideation.

    Possible cause: the decrease in DHT levels could have effects on the expression of 5α-reductase.Therapy: transdermal substitution of dihydrotestosterone; antidepressants if necessary.

  • Under dutasteride or finasteride: increase in insulin resistance under dutasteride or finasteride (increased risk of diabetes mellitus).
  • Note: There is an increased risk of high-grade prostate cancer after more than two years of therapy with a 5-alpha reductase inhibitor.
  • Red-Hand.Letter:
    • Patients should be aware of the risk of sexual dysfunction (such as erectile dysfunction, ejaculatory dysfunction, decreased libido) and informed that these may persist for more than ten years after discontinuation of therapy.
    • Patients should be informed that mood changes (including depressed mood, depression, suicidal ideation) have been reported in association with finasteride treatment.

Drug groups and their onset of action and effects on LUTS, prostate size, and Qmax

Active ingredient groups Onset of action LUTS Prostate size Qmax Residual urine
Alpha-1-adrenoceptor antagonists (α1-adrenoceptor antagonists; α1-blockers). Hours to days ++ – ++ (+)
5-alpha-reductase inhibitors * (5ARIs) Months + + – ++ ++ +)
Muscarinic receptor antagonists * * Weeks ++memory disturbance – – ++increase
Alpha-1-adrenoceptor antagonists + 5-alpha-reductase inhibitors. Days ++ + – ++ ++ (+)
Alpha-1-adrenoceptor antagonists + muscarinic receptor antagonists. Days ++ – +++ (+)
β3-agonists Weeks ++memory disturbance – – (+)
Phosphodiesterase inhibitors (PDE5 inhibitors) Weeks ++ – + –
Phytotherapeutics with β-sitosterol-containing preparations. Weeks + – (+) –

* 5α-Reductase inhibitors lead to a halving of serum PSA levels when administered for a sufficiently long time! * * Monotherapy with muscarinic receptor antagonists and pronounced bladder neck obstruction carries the risk of residual urine formation! Legend

  • LUTS: lower urinary tract symptoms.
  • Qmax: maximum urine flow

Drug groups and their onset of action and effects on LUTS, prostate size and Qmax

Active ingredient groups Onset of action LUTS Prostate size Qmax
Alpha-1-adrenoceptor antagonists* * * (α1-adrenoceptor antagonists; α1-blockers) Hours to days ++ – ++
5-alpha-reductase inhibitors (5ARIs) Months + + – ++ ++
Muscarinic receptor antagonists Weeks ++ – –
Phosphodiesterase inhibitors (PDE5 inhibitors). Weeks + – +
Alpha-1-adrenoceptor antagonists + 5-alpha-reductase inhibitors. Days ++ + – ++ ++
Alpha-1-adrenoceptor antagonists + muscarinic receptor antagonists. Days ++ – +++
Phytotherapeutics with β-sitosterol-containing preparations. Weeks + – (+)

* 5α-Reductase inhibitors lead to a halving of serum PSA levels when administered for a sufficiently long time! * * Monotherapy with muscarinic receptor antagonists and pronounced bladder neck obstruction carries the risk of residual urine formation! * * * 3-6 months after discontinuation of monotherapy with alpha blockers, patients reported more severe symptoms than those who continued to take their preparations.Legend.

  • LUTS: lower urinary tract symptoms.
  • Qmax: maximum urine flow

Phytotherapeutics

Active ingredients Dosage Special features/side effects
Phytosterols like-sitosterol Depending on the preparation, e.g., 2 x 65 mg/d. Improvement in urologic symptoms and urinary streamGastrointestinal (nausea, abdominal pain (abdominal pain)), skin rash
Rye pollen(Secale cereale) Depending on the preparation, e.g. 2-3 x 2 capsules (no dose information). No data
Nettle root(Urtica dioica) Depending on the preparation, e.g. 285 mg/d. Gastrointestinal (nausea, vomiting, meteorism), skin rash.
Pumpkin seed(Cucurbita pepo). Depending on the preparation No data
Saw palmetto fruit(Serenoa repens, Sabal serrulata). Depending on the preparation, e.g. 2 x 160 mg. Improvement in nocturia (nocturnal urination) and urinary flow rateGastrointestinal (nausea, vomiting, diarrhea) overdose
  • The efficacy of phytotherapeutics has not yet been conclusively proven; in part, they have a decongestive effect (e.g.B. Beta-sitosterol)

Supplements (dietary supplements; vital substances)

Suitable dietary supplements should contain the following vital substances:

Note: The listed vital substances are not a substitute for drug therapy. Food supplements are intended to supplement the general diet in the particular life situation.