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Benign Prostate EnlargementNCT07357168

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

A study testing pulsed electromagnetic field and Treadmill machine in people with Benign Prostate Enlargement, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 60 to 75 years, men only
Conditions the study is for
Benign Prostate Enlargement
What is being tested?
pulsed electromagnetic field and Treadmill machine
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteEgypt
Study dates
1 Jan 2026to 20 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Physical Therapy

    Cairo, El Mohandsen, 02

Other trials in Egypt

About this study

Official title: Effect of Electromagnetic Field Therapy Versus Aerobic Exercise on Prostatic Function in Elderly With Benign Prostatic Hyperplasia

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

Read the detailed 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 evidence demonstrates that regular physical activity significantly enhances quality of life for men with benign prostatic hyperplasia (BPH). found that moderate-intensity aerobic exercise (30-60 minutes, 3-5 times weekly) improved International Prostate Symptom Score (IPSS) by an average of 3.2 points and quality of life scores by 1.5 points compared to sedentary controls. The study attributed these benefits to reduced prostatic inflammation and improved pelvic floor muscle function ,Human observational studies and reviews support that higher levels of physical activity-including aerobic modalities-are associated with lower odds of BPH and LUTS. A systematic review and meta analysis of observational studies found that compared to sedentary lifestyle, moderate to vigorous physical activity was linked to a significantly reduced risk of BPH/LUTS. While randomized controlled evidence remains limited and rated as very low certainty, some small trials (including tai chi and pelvic floor training) demonstrated improvements in symptom scores (e.g. IPSS reduction by ~6-8 points) when compared to waiting or conventional treatment. Together, these findings suggest that regular aerobic exercise may reduce urinary frequency, nocturia, urgency, and weak urinary stream associated with BPH, possibly via metabolic and anti inflammatory mechanisms ,The present study aimed to evaluate the comparative effects of pulsed electromagnetic field (PEMF) therapy and aerobic exercise training on prostatic function in elderly males diagnosed with benign prostatic hyperplasia (BPH). Seventy-five participants were randomly assigned into three equal groups: Group (A) received EMF therapy in addition to medical treatment program, Group (B) received aerobic exercise training in addition to medical treatment program, and Group (C) received medical treatment program alone. Baseline characteristics, including age and body mass index (BMI), revealed no statistically significant differences among the three groups, confirming their initial comparability. Following the intervention period, all groups demonstrated significant within-group improvements in clinical measures, including prostate volume, serum prostate-specific antigen (PSA), the International Prostate Symptom Score (IPSS), the American Urological Association Symptom Index (AUA-SI), and the Older People's Quality of Life Questionnaire (OPQOL-35). However, the extent of improvement varied across the groups,All groups showed significant improvements in prostate volume, PSA, IPSS, AUA-SI, and OPQOL-35 scores. However, Group (A) (PEMF) showed the most notable improvements, particularly in symptom scores and quality of life. These outcomes suggested that PEMF therapy may improve prostatic health by reducing inflammation, enhancing vascular function, and modulating cellular activity.

The findings aligned with emerging literature supporting PEMF's regenerative and anti-inflammatory effects, though its application in urology remains underexplored. This study provided promising evidence for incorporating PEMF therapy into physiotherapy for BPH, offering a safe, effective, and well-tolerated alternative to invasive management for elderly patients, This study provided strong evidence supporting that pulsed electromagnetic field (PEMF) therapy as an effective, non-invasive adjunct for managing Benign Prostatic Hyperplasia (BPH) in elderly men. PEMF improved both objective outcomes, such as prostate volume, and subjective measures, including LUTS and quality of life, without the adverse effects often associated with pharmacological or surgical treatments.

Being tested
pulsed electromagnetic field, Treadmill machine
Keywords
electromagnetic, prostaticenlargment, aerobicexercise
Medical subject headings
Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pulsed electromagnetic fieldDevice

    It was applied for all patient in the study group (A) only for 25 minutes per session, three times per week, for 12 consecutive weeks

  • Treadmill machineDevice

    was applied for all patients in the study group (B) only. Each session started with 10 minutes of warm-up (dynamic stretching mainly of the lower limbs, ten right and left hip rotations, and ten arm rotations forward and backward), followed by treadmill walking for up to 20-30 minutes and ended with a phase of 10 minutes of cool-down. During the training, the patient was asked to correct the posture during walking with verbal instructions.

Study groups in NCT07357168
Study groupRoleWhat they receive
Pulsed electro magnetic field therapyActive comparatorIt was applied for patients in the study group (A) only for 25 minutes per session, three times per week, for 12 consecutive weeks.
Receives: Device: pulsed electromagnetic field
aerobic exercise trainingActive comparatorIt was applied for patients in the study group (B) only. Each session started with 10 minutes of warm-up, followed by treadmill walking for up to 20-30 minutes and ended with a phase of 10 minutes of cool-down.
Receives: Device: Treadmill machine
Routine medical treatmentOtherIt was conducted for the three groups (A), (B), and (C).
Receives: Device: pulsed electromagnetic field; Device: Treadmill machine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. prostate volume

    This procedure required little to no special preparation, comfortable clothing. The patient was asked to wear a gown and to lie on his side with his knees toward his chest. To obtain high-quality images, an ultrasound transducer - a plastic cylinder about the size of a finger - was inserted a short distance into the rectum. The transducer was covered with a protective sheath and lubricated with gel.

    Measured: 12 weeks

Secondary outcomes (2)
  1. International prostate symptom score (IPSS)

    There are 7 questions relating to different symptoms the patient may be experiencing and one question relating to his overall quality of life. Once the patient scored each question, the values were added together to give an indication of the severity of the patient symptoms,The score is graded as 0-7: Mild 8-19: Moderate 20-35: Severe

    Measured: 12 weeks

  2. The Older People's Quality of Life Questionnaire (OPQOL-35)

    contains 35 items tapping into eight domains including life overall, health, social relationships and participation, independence, control over life and freedom, home and neighborhood, psychological and emotional well-being, financial circumstances, culture and religion. The participant was asked to indicate the extent to which agreed with every single statement by choosing one of five possible options among "strongly disagree", "disagree", "neither agree nor disagree", "agree" and "strongly agree"

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2026
  2. Study start1 Jan 2026
  3. Primary completion20 Apr 2026
  4. Study completion20 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The design of the study was randomized controlled trial (RCT), pre test, post test assessment.This study was carried out on seventy five male elderly patients diagnosed with benign prostatic hyperplasia. Their age ranged from 60 to 75 years old. The patients of this study were randomly assigned into three equal groups (n= 25): Group A (Study group): received pulsed electromagnetic field therapy in addition to medcial treatment program. Group B (Study group): received aerobic exercise training in addition to medical treatment program. Group C (Control group): received the medical treatment program only.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07357168
Sponsor's protocol ID
(P.T.REC/012/004895)
Status last verified
Dec 2025
First submitted
13 Jan 2026
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: because of its indivdual data

Questions about this trial

What is this clinical trial studying?

A study testing pulsed electromagnetic field and Treadmill machine in people with Benign Prostate Enlargement, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

prostate volume (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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