Different Transcutaneous Electrical Nerve Stimulation Modes in Pudendal Neuralgia Post-prostatectomy
NCT07348952 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-01-16
Summary
The purpose of this study was to evaluate the therapeutic efficacy of two different Transcutaneous Electrical Nerve Stimulation modes in improving the pudendal neuralgia and its intractable perineal pain.
Conditions
- Transcutaneous Electrical Nerve Stimulation
- Pudendal Neuralgia
- Post Prostatectomy
Interventions
- DEVICE
-
conventional Transcutaneous Electrical Nerve Stimulation
A Transcutaneous Electrical Nerve Stimulation stimulator Zimmer Elektromedizingalva 5, from Germany was used. The Transcutaneous Electrical Nerve Stimulation treatment will be applied once daily, three times per week for three months. Each session lasts 20 minutes, using two electrodes over the perineal area on the Centrum tendineum and two under the buttocks at the ischial spines. The patient will be in a comfortable supine hook-lying position with abducted hips. The electrode surface area must be at least 4 cm² to prevent burns, and the interelectrode distance will not be less than the electrode's diameter. Adhesive electrodes will be used, or alternatively, moistened with jelly and secured with adhesive tape in the recommended areas. Square wave form with a frequency of 80-100 Hz and intensity of 10-30 milli ampere, associated with a pulse width of 50-60 µsec, generates comfortable paresthesia (tingling) without significant muscle contractions or fasciculations.
- DEVICE
-
Acupuncture-like) transcutaneous Electrical Nerve Stimulation
A Transcutaneous Electrical Nerve Stimulation stimulator Zimmer Elektromedizingalva 5, from Germany was used. The Transcutaneous Electrical Nerve Stimulation treatment will be applied once daily, three times per week for three months. Each session lasts 20 minutes, using two electrodes over the perineal area on the Centrum tendineum and two under the buttocks at the ischial spines. The patient will be in a comfortable supine hook-lying position with abducted hips. The electrode surface area must be at least 4 cm² to prevent burns, and the interelectrode distance will not be less than the electrode's diameter. Adhesive electrodes will be used, or alternatively, moistened with jelly and secured with adhesive tape in the recommended areas. Square wave form with a frequency under 10 Hz and an intensity of 30 to 80 milli ampere will produce rhythmic, visible muscle contractions lasting 300-400 msec, tailored to the subject's tolerance at the same electrode placement.
- OTHER
-
Traditional physical therapy
Traditional physical therapy for pudendal neuralgia following prostatectomy emphasizes conservative pain management and restoring pelvic floor function. This includes patient education, activity modification, postural correction, and supportive cushions to reduce perineal pressure. Pain relief methods involve thermal applications and relaxation techniques, while pelvic floor therapy focuses on muscle relaxation through manual therapy and myofascial release. Treatment introduces gentle stretching, neural mobilization, and stabilization exercises, tailored to the patient's needs and often coordinated with a multidisciplinary team.
- DRUG
-
Gabapentin
First-line treatments for neuropathic pain include gabapentin, pregabalin, tricyclic antidepressants (like amitriptyline), and SNRIs (such as duloxetine). NSAIDs and simple analgesics may address associated inflammatory pain but are less effective for neuropathic pain specifically. Muscle relaxants can help with pelvic floor spasms, and topical agents like lidocaine offer localized relief. For persistent symptoms, pudendal nerve blocks may be performed by specialists.
Sponsors & Collaborators
-
Cairo University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 60 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-01
- Primary Completion
- 2025-01-01
- Completion
- 2025-03-01
Countries
- Egypt
Study Locations
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