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

NCT07357168 | Enrolling By Invitation DMC

• 1 other identifier: (P.T.REC/012/004895)
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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. 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LUTS due to BPH increases with age, BPH was primarily treated surgically for many years, however, in the 1990s this was superseded by the medical approaches that are now the front line therapy. 5α-reductase inhibitors such as finasteride and dutasteride and α-adrenergic blockers such as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

Conditions

Benign Prostate Enlargement

Keywords

electromagnetic; prostaticenlargment; aerobicexercise

Outcome Measures

Primary Outcomes (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.

  12 weeks

Secondary Outcomes (2)

• International prostate symptom score (IPSS)

  12 weeks

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

  12 weeks

Study Arms (3)

Pulsed electro magnetic field therapy

ACTIVE COMPARATOR

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

Device: pulsed electromagnetic field

aerobic exercise training

ACTIVE COMPARATOR

It 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.

Device: Treadmill machine

Routine medical treatment

OTHER

It was conducted for the three groups (A), (B), and (C).

Device: pulsed electromagnetic field; Device: Treadmill machine

Interventions

pulsed electromagnetic field DEVICE

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

Pulsed electro magnetic field therapy; Routine medical treatment

Treadmill machine DEVICE

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.

Routine medical treatment; aerobic exercise training

Eligibility Criteria

• Age: 60 Years - 75 Years
• Gender Eligibility Details: only male participants because of our study on volume prostate
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Cairo, El Mohandsen, 02, Egypt

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• El-Sayed Essam

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 21, 2026
• Study Start: January 1, 2026
• Primary Completion: April 20, 2026
• Study Completion: April 20, 2026
• Last Updated: April 22, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)