- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07324239
TECAR Therapy on Pain and Quality of Life in Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Effect of TECAR Therapy on Pain and Quality of Life in Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sixty men with chronic prostatitis/chronic pelvic pain will be sourced from the urology outpatient clinic at Tanta University hospitals in Egypt, with referrals from urologists. Patients will be randomly assigned into two groups.
Study group: It will include 30 men receiving true TECAR therapy plus dietary and life style adjustments.
Control group: It will include 30 men receiving sham TECAR therapy plus dietary and life style adjustments.
Evaluation Procedures:
- Pain, voiding, and quality of life using the National Institutes of Health-Chronic Prostatitis Symptom Index.
- Sleep quality using the Pittsburgh Sleep Quality Index.
- Erectile function using the International Index of Erectile Function.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Saher Elgayar, Ph.D
- Phone Number: +201020429911
- Email: saherlotfy020@gmail.com
Study Contact Backup
- Name: Mohammed Elhamrawy, Ph.D
Study Locations
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Tanta, Egypt
- Tanta University Hospital
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Contact:
- Mohamed Rady Ewis
- Email: mohamedrady@yahoo.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Presence of chronic prostatitis/chronic pelvic pain symptoms for more than 6 months.
- Ages will be ranged from 30 to 50 years old.
Exclusion Criteria:
- Urinary and seminal infections.
- Recent parenteral steroid administration.
- Prior prostate or pelvic surgery.
- Lower urinary tract disorders such as bladder stones.
- Implanted electronic devices as pacemakers.
- Sensory loss over the perineum.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Sham Comparator: Control group
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The procedure is similar to the active treatment of TECAR, but with the critical difference being that the output intensity of the TECAR device will be set to zero during the session.
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Active Comparator: TECAR therapy group
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WINBACK 3SE (France) will be used for TECAR therapy in this study.
To facilitate optimal distribution of endogenous heat therapy and effective contact between the active electrodes, both capacitive and resistive, and the surface of the skin, a layer of high-conductivity cream will be applied to the treatment region.
The plate, an inactive electrode, which has a specific size (21cm*15cm), will be placed on the gluteal region.
The capacitive electrode was employed for a duration of seven and a half minutes, at an intensity of 30-40%, whereas the resistance electrode will be utilized for an equivalent period over the perineum at the same intensity.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pelvic pain
Time Frame: Baseline and 8 weeks later
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Pain will be assessed using the National Institutes of Health-Chronic Prostatitis Symptom Index
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Baseline and 8 weeks later
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Quality of life of men
Time Frame: Baseline and after 8 weeks
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Quality of life will be assessed using the National Institutes of Health-Chronic Prostatitis Symptom Index
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Baseline and after 8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mohammed Saif, National institute for Gerontology
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TECAR therapy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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