Transcutaneous Electrical Nerve StimulationNCT07348952
Different Transcutaneous Electrical Nerve Stimulation Modes in Pudendal Neuralgia Post-prostatectomy
A study testing conventional Transcutaneous Electrical Nerve Stimulation, Acupuncture-like) transcutaneous Electrical Nerve Stimulation and Traditional physical therapy in people with Transcutaneous Electrical Nerve Stimulation and Pudendal Neuralgia, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 60 years, men only
- Conditions the study is for
- Transcutaneous Electrical Nerve Stimulation, Pudendal Neuralgia, Post Prostatectomy
- What is being tested?
- conventional Transcutaneous Electrical Nerve Stimulation, Acupuncture-like) transcutaneous Electrical Nerve Stimulation and Traditional physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
out-clinics of the general surgery department in Om-El Misrieen hospital
Giza
About this study
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.
Read the detailed description
The need for this study will be developed from the lack in quantitative knowledge and information in the published studies about the effects of two different transcutaneous electrical nerve stimulation modes in cases of pudendal neuralgia. The significance of this study will be raised from the persistence of this neuralgia and its intractable pain that may result in severe morbidity with repeated local injections, pain medications and numerous surgical attempts to alleviate pain as well as the increase in the period of hospitalization plus the delay in returning to normal life. So, this study will be conducted to add new information about the effect of different transcutaneous electrical nerve stimulation modes in relieving chronic pudendal neuralgia post-prostatectomy, which may help the field of physical therapy and patients suffering from pudendal neuralgia.
- Being tested
- conventional Transcutaneous Electrical Nerve Stimulation, Acupuncture-like) transcutaneous Electrical Nerve Stimulation, Traditional physical therapy, Gabapentin
- Medical subject headings
- Pudendal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional Transcutaneous Electrical Nerve StimulationDevice
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.
Acupuncture-like) transcutaneous Electrical Nerve StimulationDevice
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.
Traditional physical therapyOther
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.
GabapentinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: Acupuncture-like) transcutaneous Electrical Nerve Stimulation; Other: Traditional physical therapy; Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline and 12 weeks
Secondary outcomes (2)
assessment of pain intensity
Pain intensity was evaluated using the Visual Analog Scale (VAS), which features a 10-cm line marked from no pain (0) to worst imaginable pain (10). Participants indicated their pain level on this line, and the distance from the zero point was recorded as the pain score. VAS assessments occurred before and after treatment and are recognized as a valid and reliable method for quantifying pain intensity in clinical research.
Measured: at baseline and 12 weeks
assessment of the carbamazepine intake
it will be used to evaluate the improvement in the chronic pudendal neuralgia post-prostatectomy and its intractable perineal pain
Measured: at baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Sep 2023
- Primary completion1 Jan 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcutaneous Electrical Nerve StimulationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mahmoud Tawfik, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348952
- Sponsor's protocol ID
- Mohamed-Phd
- Status last verified
- Jan 2026
- First submitted
- 1 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Transcutaneous Electrical Nerve Stimulation Modes in Pudendal Neuralgia Post-prostatectomy
- ClinicalTrials.gov ID
- NCT07348952
- Acronym / sponsor ID
- Mohamed-Phd
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The need for this study will be developed from the lack in quantitative knowledge and information in the published studies about the effects of two different transcutaneous electrical nerve stimulation modes in cases of pudendal neuralgia. The significance of this study will be raised from the persistence of this neuralgia and its intractable pain that may result in severe morbidity with repeated local injections, pain medications and numerous surgical attempts to alleviate pain as well as the increase in the period of hospitalization plus the delay in returning to normal life. So, this study will be conducted to add new information about the effect of different transcutaneous electrical nerve stimulation modes in relieving chronic pudendal neuralgia post-prostatectomy, which may help the field of physical therapy and patients suffering from pudendal neuralgia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional Transcutaneous Electrical Nerve Stimulation | Experimental | Device: conventional Transcutaneous Electrical Nerve Stimulation, Other: Traditional physical therapy, Drug: Gabapentinwas 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. |
| Acupuncture-like) transcutaneous Electrical Nerve Stimulation | Active comparator | Device: Acupuncture-like) transcutaneous Electrical Nerve Stimulation, Other: Traditional physical therapy, Drug: Gabapentinthat 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 |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional Transcutaneous Electrical Nerve StimulationA 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 | conventional Transcutaneous Electrical Nerve Stimulation |
| Acupuncture-like) transcutaneous Electrical Nerve StimulationA 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. | Device | Acupuncture-like) transcutaneous Electrical Nerve Stimulation |
| Traditional physical therapyTraditional 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. | Other | Acupuncture-like) transcutaneous Electrical Nerve Stimulation, conventional Transcutaneous Electrical Nerve Stimulation |
| GabapentinFirst-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. | Drug | Acupuncture-like) transcutaneous Electrical Nerve Stimulation, conventional Transcutaneous Electrical Nerve Stimulation |
Primary outcome
measurement of Serum cortisol level
Time frame: at baseline and 12 weeks
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.
2 secondary outcomes
assessment of pain intensity
Time frame: at baseline and 12 weeks
assessment of the carbamazepine intake
Time frame: at baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
Related trials for Transcutaneous Electrical Nerve Stimulation
Not yet recruiting
Parasacral TENS Project
Overactive Bladder (OAB), Lower Urinary Tract Dysfunction
Recruiting
Effect of Transcutaneous Electrical Stimulation on Polysomnographic Parameters in Patients With Obstructive Sleep Apnea
Obstructive Sleep Apnea
Recruiting
TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
Not yet recruiting
Transcutaneous Genital Nerves Stimulation for the Treatment of Refractory Chronic Pelvic and Genital Pain in Women.
Refractory Visceral Pelvic Pain, Refractory Genital Pain
Recruiting
Effects of Transcutaneous Electrical Nerve Stimulation on Cognitive Function and Upper Limb Motor Function in People With Chronic Stroke
Chronic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional Transcutaneous Electrical Nerve Stimulation, Acupuncture-like) transcutaneous Electrical Nerve Stimulation and Traditional physical therapy in people with Transcutaneous Electrical Nerve Stimulation and Pudendal Neuralgia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of Serum cortisol level (time frame: at baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.