Transcutaneous Electrical Nerve StimulationNCT06570512
Transcutaneous Electrical Nerve Stimulation for the Treatment of Premature Ejaculation
A study testing transcutaneous posterior tibial nerve stimulation in people with Transcutaneous Electrical Nerve Stimulation and Premature Ejaculation, run by Cairo University at 2 sites in Egypt.
Trial summary
Premature ejaculation (PE) is the most prevalent male sexual dysfunction. The currently approved treatments are intolerable to patients due to their side effects. the investigatorsconducted a blinded randomized controlled trial to evaluate the efficacy and safety of transcutaneous posterior tibial nerve stimulation… Read more about this study
- Who is it for?
- Ages 20 to 65 years, men only
- Conditions the study is for
- Transcutaneous Electrical Nerve Stimulation, Premature Ejaculation
- What is being tested?
- transcutaneous posterior tibial nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2022to 9 Dec 2023
- 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 20 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- married males
- with stable and continuous marital relationships
- diagnosed with premature ejaculation based on the International Society for Sexual Medicine (ISSM-International Society for Sexual Medicine) : (a) within the 1-2 minutes after penetration, the ejaculation always or almost always starts; (b)in all or almost all penetrations, the patient cannot delay the ejaculation; (c) PE generate negative consequences on the patients, such as discomfort, frustration, stress, and/or sexual intimacy avoidance
- and the patient did not take the treatment for PE in the previous 14 days
Who cannot join
- Patients were excluded if they had erectile dysfunction (measured by the International Index of Erectile function-ILEF-5 questionnaire),
- inhibited male orgasm
- reduced sexual desire
- uncontrolled physical illness
- active genitourinary tract infection (confirmed by two glasses of urine according to Modified Meares-Stamey technique)
- mental disorders affecting ejaculatory function such as anxiety, depression, and schizophrenia, history of alcohol or drug abuse
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Cairo University
Cairo, Giza Governorate
Faculty Of Medicine, Cairo University
Cairo, 35744
About this study
Official title: Evaluation of the Transcutaneous Electrical Nerve Stimulation of the Posterior Tibial Nerve in the Treatment of Premature Ejaculation: A Randomized Controlled Trial
Premature ejaculation (PE) is the most prevalent male sexual dysfunction. The currently approved treatments are intolerable to patients due to their side effects.
the investigatorsconducted a blinded randomized controlled trial to evaluate the efficacy and safety of transcutaneous posterior tibial nerve stimulation (TPTNS) for the treatment of PE.
5o male patients complaining of PE with intravaginal ejaculation latency time (IELT) of less than 2 minutes were randomized into two equal groups to receive either TPTNS or sham transcutaneous electrical nerve stimulation (TENS). TPTNS group underwent ten sessions of electrical stimulation of the posterior tibial nerve using a frequency of 20 Hz and a pulse width of 250 microseconds. The primary outcomes were IELT which was calculated by the patient\'s digital hand watch, and the Arabic index of premature ejaculation (AIPE).
Read the detailed description
Trial design A single blinded randomized controlled trial was used, and the ratio of allocation was 1:1.
Between 2022 and 2023, this study was conducted on (50) male patients attending the outpatient clinic of Andrology, Kasr Al Ainy Hospital, Cairo University to evaluate the efficacy and safety of transcutaneous posterior tibial nerve stimulation (TPTNS) to delay ejaculation in PE patients compared to sham transcutaneous electrical nerve stimulation (TENS).
Patients The participants included in this study were married males with stable and continuous marital relationships, diagnosed with premature ejaculation based on the International Society for Sexual Medicine (ISSM-International Society for Sexual Medicine) : (a) within the 1-2 minutes after penetration, the ejaculation always or almost always starts; (b)in all or almost all penetrations, the patient cannot delay the ejaculation; (c) PE generate negative consequences on the patients, such as discomfort, frustration, stress, and/or sexual intimacy avoidance, and the patient did not take the treatment for PE in the previous 14 days. Patients were excluded if they had erectile dysfunction (measured by the International Index of Erectile function-ILEF-5 questionnaire), inhibited male orgasm, reduced sexual desire, uncontrolled physical illness, active genitourinary tract infection (confirmed by two glasses of urine according to Modified Meares-Stamey technique), mental disorders affecting ejaculatory function such as anxiety, depression, and schizophrenia, history of alcohol or drug abuse. To exclude chronic prostatitis patients, the expressed prostatic secretions after prostatic massage were subjected to microscopic examination. Before conducting the study, informed consent was obtained from each patient.
The applied technique Over three weeks, the TPTNS group underwent ten sessions of electrical stimulation along the course of the posterior tibial nerve behind the medial malleoli using cup electrodes, with a width pulse of 250 microseconds, and a frequency of 20 Hz. The TENS group used a sham device with the same parameters, but the electrodes were placed behind the lateral malleoli with underpowered amplitudes.
Outcome measures Before and after treatment, the patients were asked to answer the Arabic Index of premature ejaculation questionnaire (AIPE) which evaluates seven items: time to ejaculation, hard erections for sufficient intercourse, control, sexual desire, satisfaction for the patient and partner, anxiety, or depression. Also, the intravaginal ejaculation latency time (IELT) was calculated using the digital hand watch, as the patients were instructed to count the time between intromission and ejaculation, and to repeat this procedure in one to two coital occasions per week over three weeks after receiving either TPTNS or TENS. The ISSM defined an IELT threshold of 2 minutes as the cut-off point for PE. The treatment success was defined as a decrease in PE severity and an improvement in AIPE score.
- Being tested
- transcutaneous posterior tibial nerve stimulation
- Keywords
- premature ejaculation, transcutaneous electrical nerve stimulation, posterior tibial nerve
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous posterior tibial nerve stimulationDevice
Also called sham transcutaneous electrical nerve stimulation (TENS).
Over three weeks, the TPTNS group underwent ten sessions of electrical stimulation along the course of the posterior tibial nerve behind the medial malleoli using cup electrodes, with a width pulse of 250 microseconds, and a frequency of 20 Hz. The TENS group used a sham device with the same parameters, but the electrodes were placed behind the lateral malleoli with underpowered amplitudes.
| Study group | Role | What they receive |
|---|---|---|
| transcutaneous posterior tibial nerve stimulation (TPTNS) | Experimental | TPTNS group underwent ten sessions of electrical stimulation along the course of the posterior tibial nerve behind the medial malleoli using cup electrodes, with a width pulse of 250 microseconds, and a frequency of 20 Hz Receives: Device: transcutaneous posterior tibial nerve stimulation |
| sham transcutaneous electrical nerve stimulation (TENS). | Active comparator | TENS group used a sham device with the same parameters, but the electrodes were placed behind the lateral malleoli with underpowered amplitudes. Receives: Device: transcutaneous posterior tibial nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intravaginal ejaculation latency time (ILET)
was calculated using the digital hand watch. The patients were instructed to count the time between intromission and ejaculation, and to repeat this procedure in one to two coital occasions per week over three weeks of receiving sessions and to continue for 2 months after end of sessions.
Measured: at the baseline (before starting the treatment sessions), then at 3 weeks (by the end of treatment) and finally 2 months later for follow up
Score of Arabic index of premature ejaculation (AIPE)
Seven item questionnaire developed by Arafa \& Shamloul in 2007 that evaluates sexual desire, hard erections for sufficient intercourse, time to ejaculation, control, satisfaction for the patient and partner, anxiety or depression.
Measured: at the baseline (before starting the treatment sessions), then at 3 weeks (by the end of treatment) and finally 2 months later for follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start1 Jan 2022
- Primary completion1 May 2023
- Study completion9 Dec 2023
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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Andrology & STDs Kasr AlAiny Cairo University
- Responsible party
- Principal investigator, Mahmoud Fawzy Ghaly, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570512
- Sponsor's protocol ID
- TPTNS for PE
- Status last verified
- Oct 2024
- First submitted
- 1 Aug 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Transcutaneous Electrical Nerve Stimulation of the Posterior Tibial Nerve in the Treatment of Premature Ejaculation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06570512
- Acronym / sponsor ID
- TPTNS for PE
- Keywords
- premature ejaculation, transcutaneous electrical nerve stimulation, posterior tibial nerve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Department of Andrology & STDs Kasr AlAiny Cairo University
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 9 Dec 2023 (actual)
- First posted
- 26 Aug 2024 (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.
Premature ejaculation (PE) is the most prevalent male sexual dysfunction. The currently approved treatments are intolerable to patients due to their side effects.
the investigatorsconducted a blinded randomized controlled trial to evaluate the efficacy and safety of transcutaneous posterior tibial nerve stimulation (TPTNS) for the treatment of PE.
5o male patients complaining of PE with intravaginal ejaculation latency time (IELT) of less than 2 minutes were randomized into two equal groups to receive either TPTNS or sham transcutaneous electrical nerve stimulation (TENS). TPTNS group underwent ten sessions of electrical stimulation of the posterior tibial nerve using a frequency of 20 Hz and a pulse width of 250 microseconds. The primary outcomes were IELT which was calculated by the patient\'s digital hand watch, and the Arabic index of premature ejaculation (AIPE).
Detailed description
Trial design A single blinded randomized controlled trial was used, and the ratio of allocation was 1:1.
Between 2022 and 2023, this study was conducted on (50) male patients attending the outpatient clinic of Andrology, Kasr Al Ainy Hospital, Cairo University to evaluate the efficacy and safety of transcutaneous posterior tibial nerve stimulation (TPTNS) to delay ejaculation in PE patients compared to sham transcutaneous electrical nerve stimulation (TENS).
Patients The participants included in this study were married males with stable and continuous marital relationships, diagnosed with premature ejaculation based on the International Society for Sexual Medicine (ISSM-International Society for Sexual Medicine) : (a) within the 1-2 minutes after penetration, the ejaculation always or almost always starts; (b)in all or almost all penetrations, the patient cannot delay the ejaculation; (c) PE generate negative consequences on the patients, such as discomfort, frustration, stress, and/or sexual intimacy avoidance, and the patient did not take the treatment for PE in the previous 14 days. Patients were excluded if they had erectile dysfunction (measured by the International Index of Erectile function-ILEF-5 questionnaire), inhibited male orgasm, reduced sexual desire, uncontrolled physical illness, active genitourinary tract infection (confirmed by two glasses of urine according to Modified Meares-Stamey technique), mental disorders affecting ejaculatory function such as anxiety, depression, and schizophrenia, history of alcohol or drug abuse. To exclude chronic prostatitis patients, the expressed prostatic secretions after prostatic massage were subjected to microscopic examination. Before conducting the study, informed consent was obtained from each patient.
The applied technique Over three weeks, the TPTNS group underwent ten sessions of electrical stimulation along the course of the posterior tibial nerve behind the medial malleoli using cup electrodes, with a width pulse of 250 microseconds, and a frequency of 20 Hz. The TENS group used a sham device with the same parameters, but the electrodes were placed behind the lateral malleoli with underpowered amplitudes.
Outcome measures Before and after treatment, the patients were asked to answer the Arabic Index of premature ejaculation questionnaire (AIPE) which evaluates seven items: time to ejaculation, hard erections for sufficient intercourse, control, sexual desire, satisfaction for the patient and partner, anxiety, or depression. Also, the intravaginal ejaculation latency time (IELT) was calculated using the digital hand watch, as the patients were instructed to count the time between intromission and ejaculation, and to repeat this procedure in one to two coital occasions per week over three weeks after receiving either TPTNS or TENS. The ISSM defined an IELT threshold of 2 minutes as the cut-off point for PE. The treatment success was defined as a decrease in PE severity and an improvement in AIPE score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transcutaneous posterior tibial nerve stimulation (TPTNS) | Experimental | Device: transcutaneous posterior tibial nerve stimulationTPTNS group underwent ten sessions of electrical stimulation along the course of the posterior tibial nerve behind the medial malleoli using cup electrodes, with a width pulse of 250 microseconds, and a frequency of 20 Hz |
| sham transcutaneous electrical nerve stimulation (TENS). | Active comparator | Device: transcutaneous posterior tibial nerve stimulationTENS group used a sham device with the same parameters, but the electrodes were placed behind the lateral malleoli with underpowered amplitudes. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- married males
- with stable and continuous marital relationships
- diagnosed with premature ejaculation based on the International Society for Sexual Medicine (ISSM-International Society for Sexual Medicine) : (a) within the 1-2 minutes after penetration, the ejaculation always or almost always starts; (b)in all or almost all penetrations, the patient cannot delay the ejaculation; (c) PE generate negative consequences on the patients, such as discomfort, frustration, stress, and/or sexual intimacy avoidance
- and the patient did not take the treatment for PE in the previous 14 days
Key exclusion criteria (6 listed)
- Patients were excluded if they had erectile dysfunction (measured by the International Index of Erectile function-ILEF-5 questionnaire),
- inhibited male orgasm
- reduced sexual desire
- uncontrolled physical illness
- active genitourinary tract infection (confirmed by two glasses of urine according to Modified Meares-Stamey technique)
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 |
|---|---|---|
| transcutaneous posterior tibial nerve stimulationAlso: sham transcutaneous electrical nerve stimulation (TENS).Over three weeks, the TPTNS group underwent ten sessions of electrical stimulation along the course of the posterior tibial nerve behind the medial malleoli using cup electrodes, with a width pulse of 250 microseconds, and a frequency of 20 Hz. The TENS group used a sham device with the same parameters, but the electrodes were placed behind the lateral malleoli with underpowered amplitudes. | Device | sham transcutaneous electrical nerve stimulation (TENS)., transcutaneous posterior tibial nerve stimulation (TPTNS) |
Primary outcome
Intravaginal ejaculation latency time (ILET)
Time frame: at the baseline (before starting the treatment sessions), then at 3 weeks (by the end of treatment) and finally 2 months later for follow up
was calculated using the digital hand watch. The patients were instructed to count the time between intromission and ejaculation, and to repeat this procedure in one to two coital occasions per week over three weeks of receiving sessions and to continue for 2 months after end of sessions.
Score of Arabic index of premature ejaculation (AIPE)
Time frame: at the baseline (before starting the treatment sessions), then at 3 weeks (by the end of treatment) and finally 2 months later for follow up
Seven item questionnaire developed by Arafa \& Shamloul in 2007 that evaluates sexual desire, hard erections for sufficient intercourse, time to ejaculation, control, satisfaction for the patient and partner, anxiety or depression.
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 26 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous posterior tibial nerve stimulation in people with Transcutaneous Electrical Nerve Stimulation and Premature Ejaculation, run by Cairo University at 2 sites 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 4 inclusion and 6 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 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Intravaginal ejaculation latency time (ILET) (time frame: at the baseline (before starting the treatment sessions), then at 3 weeks (by the end of treatment) and finally 2 months later for follow up). The study lists 2 primary outcomes in all. 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 26 Oct 2024.