Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570512
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Transcutaneous Electrical Nerve Stimulation for in the Treatment of Premature Ejaculation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Transcutaneous Electrical Nerve Stimulation of the Posterior Tibial Nerve in the Treatment of Premature Ejaculation A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 patient39s digital hand watch and the Arabic index of premature ejaculation AIPE
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 patient39s 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 11
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 bin all or almost all penetrations the patient cannot delay the ejaculation c PE generate negative consequences on the patients such as discomfort frustration stress andor 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
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 bin all or almost all penetrations the patient cannot delay the ejaculation c PE generate negative consequences on the patients such as discomfort frustration stress andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None