Different Transcutaneous Electrical Nerve Stimulation Modes in Pudendal Neuralgia Post-prostatectomy

NCT07348952 | Completed

• 1 other identifier: Mohamed-Phd
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Pudendal Neuralgia; Post Prostatectomy; Transcutaneous Electrical Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

• measurement of Serum cortisol level

  Normal morning serum cortisol levels range from 9 to 25 µg/dL, and patients with painful conditions tend to exhibit higher-than-normal serum cortisol levels. Estimation of serum cortisol levels will be performed before and after 3 months of the treatment program. A venous blood sample (8 cubic centimeter) will be collected in the morning, centrifuged, and stored at -20 °C until analysis.

  at baseline and 12 weeks

Secondary Outcomes (2)

• assessment of pain intensity

  at baseline and 12 weeks

• assessment of the carbamazepine intake

  at baseline and 12 weeks

Study Arms (2)

conventional Transcutaneous Electrical Nerve Stimulation

EXPERIMENTAL

was composed of 30 patients who received the conventional transcutaneous electrical nerve stimulation in addition to the traditional physical therapy and medical care for 3 months.

Device: conventional Transcutaneous Electrical Nerve Stimulation; Other: Traditional physical therapy; Drug: Gabapentin

Acupuncture-like) transcutaneous Electrical Nerve Stimulation

ACTIVE COMPARATOR

that was composed of 30 patients who received the SLR (Acupuncture-like) transcutaneous Electrical Nerve Stimulation in addition to the traditional physical therapy and medical care for 3 months

Device: Acupuncture-like) transcutaneous Electrical Nerve Stimulation; Other: Traditional physical therapy; Drug: Gabapentin

Interventions

conventional Transcutaneous Electrical Nerve Stimulation DEVICE

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.

conventional Transcutaneous Electrical Nerve Stimulation

Acupuncture-like) transcutaneous Electrical Nerve Stimulation DEVICE

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.

Acupuncture-like) transcutaneous Electrical Nerve Stimulation

Traditional physical therapy OTHER

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.

Acupuncture-like) transcutaneous Electrical Nerve Stimulation; conventional Transcutaneous Electrical Nerve Stimulation

Gabapentin DRUG

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.

Acupuncture-like) transcutaneous Electrical Nerve Stimulation; conventional Transcutaneous Electrical Nerve Stimulation

Eligibility Criteria

• Age: 50 Years - 60 Years
• Gender Eligibility Details: * All patients will be approximately the same age (from 50-60 years old). * All patients have chronic pudendal neuralgia post-prostatectomy surgery
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients will be chosen after a routine medical examination.
• All patients will be approximately the same age (from 50-60 years old).
• All patients have chronic pudendal neuralgia post-prostatectomy surgery.
• They have not take another physical therapy electro- modality except the traditional physical therapy in the form of pelvic floor exercises.
• All of them will be non smokers and will be under own prescribed medications described by their physicians.
• The pain is located in the pudendal nerve distribution area.
• Pain intensity increased in the sitting position.
• There were no symptoms of nocturnal pain.
• Pain with no objective sensory impairment.
• Pain was relieved by diagnostic pudendal nerve block.
• Another clinical standard provides extra support to the diagnosis of pudendal neuralgia.
• Pain symptoms may be associated with sexual dysfunction.

You may not qualify if:

• Patients have simple tailbone, gluteus muscle or lower abdominal pain, or only paroxysmal pain, or only pruritic symptoms, and/or having imaging anomalies that may explain the symptoms.
• Patients who take anticoagulant drugs or have any coagulation disorder.
• Patients who will be unable to complete the study.
• Patients with pain, which is caused by malignant or autoimmune diseases.
• Patients with life threatening disorders as renal failure, myocardial infarction or others will be excluded from the study.
• Patients who suffering from skin diseases, diabetes, varicose veins, trauma and peripheral vascular diseases will be excluded.
• Patients who suffering from myasthenia gravis, hyperthyroidism, hemorrhage, acute viral diseases, acute tuberculosis, mental disorders or those with pace makers will be excluded from the study

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

out-clinics of the general surgery department in Om-El Misrieen hospital

Giza, Egypt

Location

MeSH Terms

Conditions

Pudendal Neuralgia

Interventions

Transcutaneous Electric Nerve Stimulation; Gabapentin

Condition Hierarchy (Ancestors)

Nerve Compression Syndromes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

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

Study Record Dates

• First Submitted: January 1, 2026
• First Posted: January 16, 2026
• Study Start: September 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

EG (1)