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By invitation only Not applicable NCT07357168

Electromagnetic Field Therapy Versus Aerobic Exercise on Prostatic Function in Elderly With Benign Prostatic Hyperplasia

No applicable phase (e.g. observational)
Conditions: Benign Prostate Enlargement

Sponsor: Cairo University

trial.available_in: БГ
Overview
This study will be carried out on seventy five elderly patients with benign prostatic hyperplasia. Their age will range from 60 to 75 years old. They will be recruited from Hoda Talaat Harb geriatric care center, Helwan governorate, Egypt. The aim of this study to investigate the effect of Electromagnetic field versus aerobic exercise on benign prostatic hyperplasia. Benign prostatic hyperplasia is a nonmalignant enlargement of the prostate gland and refers to the stromal and glandular epithelial hyperplasia that occurs in the transition zone of the prostate Clinically, the condition manifests with lower urinary tract symptoms (LUTS) consisting of obstructive (weak urination stream, incomplete bladder emptying, hesitancy) and irritative symptoms (frequency, urgency, nocturia). It is important to note that LUTS can result from a variety of conditions including problems relating to bladder innervation and aging as well as the outflow obstruction caused by BPH. LUTS due to BPH increases with age, BPH was primarily treated surgically for many years, however, in the 1990s this was superseded by the medical approaches that are now the front line therapy. 5α-reductase inhibitors such as finasteride and dutasteride and α-adrenergic blockers such as doxazosin and tamsulosin are used to shrink and relax the organ, respectively. The MTOPS study demonstrated that a combination of the α-blocker Doxazosin and the 5α-reductase inhibitor Finasteride are more effective at reducing LUTS progression than either drug given alone. While these approaches are effective in many patients, a significant proportion, in the range of 35%, showed progressive disease even in the face of the two drug combination,The Electromagnetic field is thought to have the ability to affect the cells that induce different cellular changes , present studies prove that molecular synergies may not remain the unique determinants implicated in the biological interface. EMF possesses numerous well-reported biological effects including inflammation and pain suppression. This therapy is noninvasive, secure, and easy to use for treating the origin of discomfort, damage, and inflammation
Description
Benign prostatic hyperplasia (BPH) is a condition in which the prostate gland grows larger than normal, but the growth is not caused by cancer .The prostate has two main growth phases. The first growth phase happens early in puberty when the prostate doubles in size. The second growth phase starts around age 25 and continues throughout life. BPH often occurs late in the second growth phase Experts estimate that BPH affects 5% to 6% of men ages 40 to 64 and 29% to 33% of those ages 65 and older. BPH is the most common prostate problem in men older than age 50. BPH rarely causes symptoms in men younger than age 40,Benign prostatic hyperplasia (BPH) is a prostate volume (PV) enlargement due to a non-malignant cellular proliferation of the parenchyma and stroma of the gland, mainly in the transition area. BPH is a common age-related pathology, often causing lower urinary tract symptoms (LUTS) due to compression of the urethra by the enlarged prostate, which reduces the quality of life of affected patients , Pulsed electromagnetic field (PEMF) appears to act on BPH through anti-inflammatory and microvascular effects that can translate into symptomatic improvement. Experimental and translational work suggests PEMF improves prostate microcirculation and reduces tissue inflammation markers, which may decrease stromal/epithelial hyperplasia and interstitial edema-mechanisms that plausibly reduce prostate volume and obstructive lower urinary tract symptoms (LUTS). This proposed mechanism is supported by Doppler/ultrasound findings and physiologic measures reported in preclinical and human pilot studies showing improved prostatic blood flow and reduced inflammatory indices after PEMF treatment ,Regular physical exercise has been shown to positively influence benign prostatic hyperplasia (BPH), a common condition in aging men characterized by prostate enlargement and lower urinary tract symptoms (LUTS). The mechanisms by which exercise may improve BPH including hormonal modulation through reducing insulin-like growth factor-1 (IGF-1) and estrogen levels, both of which are linked to prostate growth, while increasing testosterone metabolism, potentially slowing BPH progression Physical activity (PA) has myriad health benefits, which may also extend to protection against BPH and LUTS development and progression. PA has been proposed to protect against BPH/LUTS by several possible mechanisms, including reducing body size, decreasing sympathetic nervous system activity ,The complications of benign prostatic hyperplasia may include: acute urinary retention, chronic, urinary retention, blood in the urine, urinary tract infections (UTIs), bladder damage and kidney damage Pulsed electromagnetic field therapy (PEMF) consists of low-frequency pulsed energy waves (1-50) Hz, that have been employed for many therapeutic purposes mainly because of its anti-inflammatory effect Moreover, many studies have shown that it is a safe procedure, without side effects ,Emerging evid
Who can participate
Inclusion Criteria: * Seventy five male elderly patients diagnosed with prostatic enlargement (prostate volume is greater than 40 mL) assessed by ultrasonography. * They had benign prostatic hyperplasia indicated by a serum-based prostate-specific antigen (PSA) of 4.0 - 10 ng/mL * They had moderate severity of benign prostatic hyperplasia indicated by a score of 8 to 19 according to the American Urological Association Symptom Index. * They had lower urinary tract symptoms including nocturia, incomplete emptying of the bladder, urinary hesitancy, weak stream, frequency, and urgency leading to the development of acute urinary retention. Exclusion Criteria: * Previous prostatic surgery. * Urogenital malformations, genetic syndromes, and ongoing tumors. * Uncontrolled hypertension * Pacemakers and automatic implantable cardioverter defibrillators. * Neurological disorders such as Parkinson's disease. * Prostate cancer. * Patients taking medications that affected bladder function such as antihistamines, decongestants, diuretics, opiates, and tricyclic antidepressants.
Interventions
pulsed electromagnetic field
DEVICE
Treadmill machine
DEVICE
Locations 1
Egypt (1)
Faculty of Physical Therapy
Cairo , El Mohandsen
Technical details
Status
By invitation only
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male only
Minimum age
60 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
01.01.2026
Completion date
20.04.2026
Registry ID
NCT07357168
Source
clinicaltrials.gov
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