TECAR Therapy on Pain and Quality of Life in Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TECAR therapy, Sham TECAR therapy.
- Who it may be relevant to
- Registry conditions: Prostatitis. Basic parameters: 30 years — 50 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of TECAR Therapy on Pain and Quality of Life in Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome: a Randomized Controlled Trial
Overview
Evaluate the effect of TECAR therapy on pain, voiding, erectile function, sleep quality and quality of life in men with chronic prostatitis/chronic pelvic pain syndrome.
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:
1. Pain, voiding, and quality of life using the National Institutes of Health-Chronic Prostatitis Symptom Index. 2. Sleep quality using the Pittsburgh Sleep Quality Index. 3. Erectile function using the International Index of Erectile Function.
Interventions
- Device TECAR therapy
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 ha - Device Sham TECAR therapy
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.
Primary outcome measures
- Pelvic pain [Time frame: Baseline and 8 weeks later]
Secondary outcome measures (1)
- Quality of life of men [Time frame: Baseline and after 8 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Tanta University Hospital — Tanta
Identifiers
NCT: NCT07324239 · TECAR therapy