Premature EjaculationNCT06777199
A Comparative Study of Selective Dorsal Neurectomy, Pulsed Radiofrequency Neuromodulation, and Intragranular Hyaluronic Acid Injection for Premature Ejaculation
A study testing Microscopic Selective Dorsal Neurectomy (SDN), Pulsed Radiofrequency (PRF) Nerve Ablation and Intraglanular Hyaluronic Acid (HA) Injection in people with Premature Ejaculation, run by Ahmed Hamdy Ahmed at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness and safety of three treatment methods for lifelong premature ejaculation (PE) in adult males. The main questions this study aims to answer are: Does selective dorsal neurectomy, pulsed radiofrequency nerve ablation, or hyaluronic acid injection prolong… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- Microscopic Selective Dorsal Neurectomy (SDN), Pulsed Radiofrequency (PRF) Nerve Ablation and Intraglanular Hyaluronic Acid (HA) Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2022to 1 May 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all male patients ≥ 18 years old who are having regular sexual life and suffering from lifelong premature ejaculation, not responding to medical treatment or not willing to continue on medical treatment
Who cannot join
- Patients suffering from ED
- Patients suffering of several debilitating co-morbidities (uncontrolled DM, on corticosteroids or receiving immunosuppression therapy)
- Patients suffering of neurological disorders
- Patients receiving any kind of SSRIs or topical anesthetics within 3 months to treat LPE
- Patients suffering from any other form of PE (i.e. acquired, subjective, variable PE)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study to Assess the Role of Selective Dorsal Neurectomy Versus Pulsed Radiofrequency Neuromodulation Versus Intraglanular Hyaluronic Acid Injection for Patients With Lifelong Premature Ejaculation: a Randomized Clinical Trial
The goal of this clinical trial is to evaluate the effectiveness and safety of three treatment methods for lifelong premature ejaculation (PE) in adult males. The main questions this study aims to answer are:
Does selective dorsal neurectomy, pulsed radiofrequency nerve ablation, or hyaluronic acid injection prolong intravaginal ejaculatory latency time (IELT)? What are the differences in patient satisfaction and safety among the three treatments?
Read more
In this study:
Participants will be randomized into three groups (10 patients each). Group 1 will undergo selective dorsal neurectomy under local or spinal anesthesia.
Group 2 will receive pulsed radiofrequency nerve ablation sessions. Group 3 will have hyaluronic acid injections into the glans penis under local anesthesia.
Researchers will measure treatment outcomes using:
Stopwatch measurements of IELT. Patient-reported questionnaires (IPE, PEP). International Index of Erectile Function-5 (IIEF-5) to confirm no erectile dysfunction.
Read the detailed description
This randomized clinical trial aims to assess the efficacy and safety of three treatment modalities for lifelong premature ejaculation (PE) in adult males. Premature ejaculation is a common male sexual dysfunction that significantly impacts quality of life, affecting relationships and psychological well-being. The study will compare three therapeutic approaches: selective dorsal neurectomy, pulsed radiofrequency nerve ablation, and intraglanular hyaluronic acid injection.
Study Population:
Male patients aged 18 years and older. Participants must have lifelong PE that has not responded to or cannot be continued with medical treatment.
Patients with erectile dysfunction, severe comorbidities, or recent use of SSRIs or topical anesthetics will be excluded.
Intervention Groups:
Selective Dorsal Neurectomy (SDN):
Performed under spinal or local anesthesia. Involves microsurgical dissection of the dorsal penile nerves to reduce glans sensitivity.
Pulsed Radiofrequency Nerve Ablation (PRF):
Involves neuromodulation of the dorsal penile nerves using pulsed radiofrequency energy.
The goal is to reduce glans sensation while preserving nerve function.
Hyaluronic Acid Injection:
Hyaluronic acid is injected into the glans penis using the multiple puncture technique under local anesthesia to reduce sensitivity.
Outcome Measures:
Primary Outcomes:
Prolongation of intravaginal ejaculatory latency time (IELT) using stopwatch measurements.
Improvement in patient-reported outcomes via validated questionnaires (IPE, PEP).
Secondary Outcomes:
Improvement in patient and partner sexual satisfaction. Presence of voluntary control of ejaculation. Reduction in stress and psychological distress.
Study Design:
A total of 30 patients will be randomized into three equal groups (10 patients per group).
The follow-up period includes evaluations at 1 month and 3 months post-intervention.
Diagnostic tools include IELT stopwatch measures, penile duplex ultrasound, and questionnaires.
Statistical Analysis:
Data will be analyzed using SPSS software. Descriptive statistics (mean, standard deviation) and comparative tests (paired t-tests, Chi-square tests) will determine the significance of results.
This study aims to provide evidence-based guidance on the optimal treatment strategy for lifelong premature ejaculation, focusing on efficacy, safety, and patient satisfaction.
- Conditions
- Premature Ejaculation
- Being tested
- Microscopic Selective Dorsal Neurectomy (SDN), Pulsed Radiofrequency (PRF) Nerve Ablation, Intraglanular Hyaluronic Acid (HA) Injection
- Keywords
- lifelong premature ejaculation, Microscopic Selective Dorsal Neurectomy, intraglanular Hyaluronic acid, pulsed radiofrequency ablation
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microscopic Selective Dorsal Neurectomy (SDN)Procedure or surgery
Selective dorsal neurectomy (SDN) involves microsurgical dissection and partial transection of the dorsal penile nerves to reduce glans sensitivity.
The procedure is performed under spinal anesthesia or local anesthesia with 1% lidocaine.
A midline or dorsal sub-coronal incision is made 1 cm proximal to the coronal sulcus.
The skin is retracted, exposing the Dartos fascia and Buck's fascia to reach the neurovascular bundle (two dorsal penile nerves lateral to two dorsal penile arteries).
Every other nerve on either side of the corpora cavernosa is transected to damage approximately 50% of the nerve supply to the glans.
Suturing is done using 7-0 or 8-0 prolene sutures, and the incision is closed. Patients are evaluated at 1 month and 3 months post-procedure for IELT, AIPE, and PEDT scores to determine success.
Pulsed Radiofrequency (PRF) Nerve AblationProcedure or surgery
Pulsed radiofrequency (PRF) nerve ablation aims to reduce sensitivity of the dorsal penile nerves using low-energy radiofrequency pulses.
Under sterile conditions, a 22-gauge RF cannula (5-cm-long, 10-mm active tip) is inserted into the flaccid penile skin at the 1-o'clock position for the right dorsal penile nerve.
Sensory stimulation testing is performed at 50 Hz to identify the point of maximum glans sensitivity.
Pulsed radiofrequency is applied at an energy output of 45 V for 180 seconds at 42°C (using the NeuroTherm generator).
The procedure is repeated at the 11-o'clock position for the left dorsal penile nerve, ensuring both sides are treated.
The goal is to ablate sensation over as large an area of the glans as possible without causing permanent nerve damage.
Post-procedure, patients are evaluated at 1 and 3 months for IELT, AIPE, and PEDT scores.
Intraglanular Hyaluronic Acid (HA) InjectionProcedure or surgery
Intraglanular hyaluronic acid (HA) injection involves administering HA gel into the glans penis to reduce its sensitivity.
The circumference of the glans penis is divided into three circles (1 cm apart, starting from the base), and each circle is further divided into quarter circles.
Topical anesthetic cream (Emla®, lidocaine 25 mg + prilocaine 25 mg) is applied for 30 minutes to numb the glans.
Using two prefilled syringes of HA gel (Hyabell Ultra® 24 mg/ml with 0.3% lidocaine), 12 injections are administered into the deep dermis of the glans using a 27-G needle.
Each injection site receives 0.25 ml of HA gel following the multiple puncture technique.
Patients are evaluated at 1 and 3 months for IELT, AIPE, and PEDT scores to assess efficacy.
| Study group | Role | What they receive |
|---|---|---|
| Microscopic Selective Dorsal Neurectomy Group | Experimental | Participants in this group will undergo microscopic selective dorsal neurectomy (SDN). The procedure involves partial transection of the dorsal penile nerves under spinal or local anesthesia to reduce sensitivity of the glans penis. Post-procedure, outcomes will be assessed at 1 and 3 months using stopwatch-measured intravaginal ejaculatory latency time (IELT) and validated questionnaires (AIPE, PEDT, and PEP). Receives: Procedure: Microscopic Selective Dorsal Neurectomy (SDN) |
| Pulsed Radiofrequency Nerve Ablation Group | Experimental | Participants in this group will receive pulsed radiofrequency (PRF) neuromodulation targeting the dorsal penile nerves. The procedure involves delivering low-energy radiofrequency pulses through an RF cannula inserted into the flaccid penile skin. The goal is to reduce glans sensitivity and improve IELT. Outcomes will be evaluated at 1 and 3 months using stopwatch-measured IELT and validated questionnaires (AIPE, PEDT, and PEP). Receives: Procedure: Pulsed Radiofrequency (PRF) Nerve Ablation |
| Intraglanular Hyaluronic Acid Injection Group | Experimental | Participants in this group will receive intraglanular hyaluronic acid (HA) injections. The circumference of the glans penis will be divided into multiple sections, and HA gel will be injected under local anesthesia to reduce glans sensitivity. Outcomes will be assessed at 1 and 3 months using stopwatch-measured IELT and validated questionnaires (AIPE, PEDT, and PEP). Receives: Procedure: Intraglanular Hyaluronic Acid (HA) Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolongation of intravaginal ejaculatory latency time (IELT)
Measured: 1 month and 3 months
Improvement in patient-reported outcomes using the Index of Premature Ejaculation (IPE) questionnaire
The IPE questionnaires scoring is normally classified to measure severity as follows:
- IPE scoring (the lower the score, the higher the PE severity): Severe PE: 7-13 Moderate PE: 14-19 Mild to Moderate PE: 20-25 Mild PE: 26-30 No PE: 31-35
Measured: 1 month and 3 months
Improvement in patient-reported outcomes using the Premature Ejaculation Diagnostic Tool (PEDT) questionnaire
The PEDT questionnaire scoring is normally classified to measure severity as follows:
- PEDT scoring (the lower the score, the lower the PE probability): Highly PE: ≥11 Borderline PE: 9-10 No PE: ≤ 8
Measured: 1 month and 3 months
Secondary outcomes (2)
Improvement in patient and partner sexual satisfaction
Sexual Satisfaction Scale (SSS)
Minimum Value: 4 (very dissatisfied across all items) Maximum Value: 20 (very satisfied across all items)
Scoring: The SSS evaluates sexual satisfaction using four items rated on a 5-point scale:
1 = Very dissatisfied 2 = Dissatisfied 3 = Neutral 4 = Satisfied 5 = Very satisfied
Interpretation: Higher scores indicate greater overall sexual satisfaction for the patient and their partner.
Assessment Method:
Patients and their partners independently complete the Sexual Satisfaction Scale (SSS) questionnaire.
The total score is calculated separately for the patient and partner. The average score across both individuals is used for reporting overall satisfaction.
Measured: 1 month and 3 months
Presence of voluntary control of ejaculation
Measured: 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start1 Jul 2022
- Primary completion1 Apr 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature EjaculationStudies of the same condition, open and under way.
- 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
- Model description
- This study uses a parallel-group design with three independent intervention arms. Thirty male patients with lifelong premature ejaculation (PE) were randomly assigned into one of the following treatment groups: Group A: Selective dorsal neurectomy performed under spinal anesthesia. Group B: Pulsed radiofrequency nerve ablation under local anesthesia. Group C: Intraglanular hyaluronic acid injection under local anesthesia. Participants remain in their respective groups throughout the study, and outcomes, including intravaginal ejaculatory latency time (IELT), Arabic Index of Premature Ejaculation (AIPE), and Premature Ejaculation Diagnostic Tool (PEDT) scores, are evaluated at 1 month and 3 months post-intervention.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Hamdy Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Hamdy Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777199
- Sponsor's protocol ID
- MD-273-2022
- Status last verified
- Jan 2025
- First submitted
- 20 Dec 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study to Assess the Role of Selective Dorsal Neurectomy Versus Pulsed Radiofrequency Neuromodulation Versus Intraglanular Hyaluronic Acid Injection for Patients With Lifelong Premature Ejaculation: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06777199
- Acronym / sponsor ID
- MD-273-2022
- Conditions
- Premature Ejaculation
- Keywords
- lifelong premature ejaculation, Microscopic Selective Dorsal Neurectomy, intraglanular Hyaluronic acid, pulsed radiofrequency ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ahmed Hamdy AhmedUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 15 Jan 2025 (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 goal of this clinical trial is to evaluate the effectiveness and safety of three treatment methods for lifelong premature ejaculation (PE) in adult males. The main questions this study aims to answer are:
Does selective dorsal neurectomy, pulsed radiofrequency nerve ablation, or hyaluronic acid injection prolong intravaginal ejaculatory latency time (IELT)? What are the differences in patient satisfaction and safety among the three treatments?
In this study:
Participants will be randomized into three groups (10 patients each). Group 1 will undergo selective dorsal neurectomy under local or spinal anesthesia.
Group 2 will receive pulsed radiofrequency nerve ablation sessions. Group 3 will have hyaluronic acid injections into the glans penis under local anesthesia.
Researchers will measure treatment outcomes using:
Stopwatch measurements of IELT. Patient-reported questionnaires (IPE, PEP). International Index of Erectile Function-5 (IIEF-5) to confirm no erectile dysfunction.
Detailed description
This randomized clinical trial aims to assess the efficacy and safety of three treatment modalities for lifelong premature ejaculation (PE) in adult males. Premature ejaculation is a common male sexual dysfunction that significantly impacts quality of life, affecting relationships and psychological well-being. The study will compare three therapeutic approaches: selective dorsal neurectomy, pulsed radiofrequency nerve ablation, and intraglanular hyaluronic acid injection.
Study Population:
Male patients aged 18 years and older. Participants must have lifelong PE that has not responded to or cannot be continued with medical treatment.
Patients with erectile dysfunction, severe comorbidities, or recent use of SSRIs or topical anesthetics will be excluded.
Intervention Groups:
Selective Dorsal Neurectomy (SDN):
Performed under spinal or local anesthesia. Involves microsurgical dissection of the dorsal penile nerves to reduce glans sensitivity.
Pulsed Radiofrequency Nerve Ablation (PRF):
Involves neuromodulation of the dorsal penile nerves using pulsed radiofrequency energy.
The goal is to reduce glans sensation while preserving nerve function.
Hyaluronic Acid Injection:
Hyaluronic acid is injected into the glans penis using the multiple puncture technique under local anesthesia to reduce sensitivity.
Outcome Measures:
Primary Outcomes:
Prolongation of intravaginal ejaculatory latency time (IELT) using stopwatch measurements.
Improvement in patient-reported outcomes via validated questionnaires (IPE, PEP).
Secondary Outcomes:
Improvement in patient and partner sexual satisfaction. Presence of voluntary control of ejaculation. Reduction in stress and psychological distress.
Study Design:
A total of 30 patients will be randomized into three equal groups (10 patients per group).
The follow-up period includes evaluations at 1 month and 3 months post-intervention.
Diagnostic tools include IELT stopwatch measures, penile duplex ultrasound, and questionnaires.
Statistical Analysis:
Data will be analyzed using SPSS software. Descriptive statistics (mean, standard deviation) and comparative tests (paired t-tests, Chi-square tests) will determine the significance of results.
This study aims to provide evidence-based guidance on the optimal treatment strategy for lifelong premature ejaculation, focusing on efficacy, safety, and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This study uses a parallel-group design with three independent intervention arms. Thirty male patients with lifelong premature ejaculation (PE) were randomly assigned into one of the following treatment groups: Group A: Selective dorsal neurectomy performed under spinal anesthesia. Group B: Pulsed radiofrequency nerve ablation under local anesthesia. Group C: Intraglanular hyaluronic acid injection under local anesthesia. Participants remain in their respective groups throughout the study, and outcomes, including intravaginal ejaculatory latency time (IELT), Arabic Index of Premature Ejaculation (AIPE), and Premature Ejaculation Diagnostic Tool (PEDT) scores, are evaluated at 1 month and 3 months post-intervention.
| Arm | Type | Receives |
|---|---|---|
| Microscopic Selective Dorsal Neurectomy Group | Experimental | Procedure: Microscopic Selective Dorsal Neurectomy (SDN)Participants in this group will undergo microscopic selective dorsal neurectomy (SDN). The procedure involves partial transection of the dorsal penile nerves under spinal or local anesthesia to reduce sensitivity of the glans penis. Post-procedure, outcomes will be assessed at 1 and 3 months using stopwatch-measured intravaginal ejaculatory latency time (IELT) and validated questionnaires (AIPE, PEDT, and PEP). |
| Pulsed Radiofrequency Nerve Ablation Group | Experimental | Procedure: Pulsed Radiofrequency (PRF) Nerve AblationParticipants in this group will receive pulsed radiofrequency (PRF) neuromodulation targeting the dorsal penile nerves. The procedure involves delivering low-energy radiofrequency pulses through an RF cannula inserted into the flaccid penile skin. The goal is to reduce glans sensitivity and improve IELT. Outcomes will be evaluated at 1 and 3 months using stopwatch-measured IELT and validated questionnaires (AIPE, PEDT, and PEP). |
| Intraglanular Hyaluronic Acid Injection Group | Experimental | Procedure: Intraglanular Hyaluronic Acid (HA) InjectionParticipants in this group will receive intraglanular hyaluronic acid (HA) injections. The circumference of the glans penis will be divided into multiple sections, and HA gel will be injected under local anesthesia to reduce glans sensitivity. Outcomes will be assessed at 1 and 3 months using stopwatch-measured IELT and validated questionnaires (AIPE, PEDT, and PEP). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all male patients ≥ 18 years old who are having regular sexual life and suffering from lifelong premature ejaculation, not responding to medical treatment or not willing to continue on medical treatment
Key exclusion criteria (5 listed)
- Patients suffering from ED
- Patients suffering of several debilitating co-morbidities (uncontrolled DM, on corticosteroids or receiving immunosuppression therapy)
- Patients suffering of neurological disorders
- Patients receiving any kind of SSRIs or topical anesthetics within 3 months to treat LPE
- Patients suffering from any other form of PE (i.e. acquired, subjective, variable PE)
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 |
|---|---|---|
| Microscopic Selective Dorsal Neurectomy (SDN)Selective dorsal neurectomy (SDN) involves microsurgical dissection and partial transection of the dorsal penile nerves to reduce glans sensitivity. The procedure is performed under spinal anesthesia or local anesthesia with 1% lidocaine. A midline or dorsal sub-coronal incision is made 1 cm proximal to the coronal sulcus. The skin is retracted, exposing the Dartos fascia and Buck's fascia to reach the neurovascular bundle (two dorsal penile nerves lateral to two dorsal penile arteries). Every other nerve on either side of the corpora cavernosa is transected to damage approximately 50% of the nerve supply to the glans. Suturing is done using 7-0 or 8-0 prolene sutures, and the incision is closed. Patients are evaluated at 1 month and 3 months post-procedure for IELT, AIPE, and PEDT scores to determine success. | Procedure or surgery | Microscopic Selective Dorsal Neurectomy Group |
| Pulsed Radiofrequency (PRF) Nerve AblationPulsed radiofrequency (PRF) nerve ablation aims to reduce sensitivity of the dorsal penile nerves using low-energy radiofrequency pulses. Under sterile conditions, a 22-gauge RF cannula (5-cm-long, 10-mm active tip) is inserted into the flaccid penile skin at the 1-o'clock position for the right dorsal penile nerve. Sensory stimulation testing is performed at 50 Hz to identify the point of maximum glans sensitivity. Pulsed radiofrequency is applied at an energy output of 45 V for 180 seconds at 42°C (using the NeuroTherm generator). The procedure is repeated at the 11-o'clock position for the left dorsal penile nerve, ensuring both sides are treated. The goal is to ablate sensation over as large an area of the glans as possible without causing permanent nerve damage. Post-procedure, patients are evaluated at 1 and 3 months for IELT, AIPE, and PEDT scores. | Procedure or surgery | Pulsed Radiofrequency Nerve Ablation Group |
| Intraglanular Hyaluronic Acid (HA) InjectionIntraglanular hyaluronic acid (HA) injection involves administering HA gel into the glans penis to reduce its sensitivity. The circumference of the glans penis is divided into three circles (1 cm apart, starting from the base), and each circle is further divided into quarter circles. Topical anesthetic cream (Emla®, lidocaine 25 mg + prilocaine 25 mg) is applied for 30 minutes to numb the glans. Using two prefilled syringes of HA gel (Hyabell Ultra® 24 mg/ml with 0.3% lidocaine), 12 injections are administered into the deep dermis of the glans using a 27-G needle. Each injection site receives 0.25 ml of HA gel following the multiple puncture technique. Patients are evaluated at 1 and 3 months for IELT, AIPE, and PEDT scores to assess efficacy. | Procedure or surgery | Intraglanular Hyaluronic Acid Injection Group |
Primary outcome
Prolongation of intravaginal ejaculatory latency time (IELT)
Time frame: 1 month and 3 months
Improvement in patient-reported outcomes using the Index of Premature Ejaculation (IPE) questionnaire
Time frame: 1 month and 3 months
The IPE questionnaires scoring is normally classified to measure severity as follows: • IPE scoring (the lower the score, the higher the PE severity): Severe PE: 7-13 Moderate PE: 14-19 Mild to Moderate PE: 20-25 Mild PE: 26-30 No PE: 31-35
Improvement in patient-reported outcomes using the Premature Ejaculation Diagnostic Tool (PEDT) questionnaire
Time frame: 1 month and 3 months
The PEDT questionnaire scoring is normally classified to measure severity as follows: • PEDT scoring (the lower the score, the lower the PE probability): Highly PE: ≥11 Borderline PE: 9-10 No PE: ≤ 8
2 secondary outcomes
Improvement in patient and partner sexual satisfaction
Time frame: 1 month and 3 months
Presence of voluntary control of ejaculation
Time frame: 1 month and 3 months
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 22 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Premature Ejaculation
Not yet recruiting
Male Pelvic Floor Muscle Rehabilitation Exercises
Erectile Dysfunction, Urinary Incontinence
RecruitingObservational study
Ejaculatory and Orgasmic Dysfunction Registry
Ejaculatory Dysfunction, Premature Ejaculation
RecruitingPhase 2
Study to Evaluate the Potential Effects of KH-001 on Intravaginal Ejaculatory Latency Time (IELT), Patient-Reported Outcomes, and Safety in Men With Lifelong Premature Ejaculation (LPE)
Premature Ejaculation
Not yet recruitingPhase 2
Evaluate the Efficacy and Safety of VV913 Capsules in the Treatment of PE
Premature Ejaculation
Active, not recruitingObservational study
Impact of Depression Severity on Sexual Dysfunction
Depression, Erectile Dysfunction
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 Microscopic Selective Dorsal Neurectomy (SDN), Pulsed Radiofrequency (PRF) Nerve Ablation and Intraglanular Hyaluronic Acid (HA) Injection in people with Premature Ejaculation, run by Ahmed Hamdy Ahmed 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 1 inclusion and 5 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 22 Jan 2025. 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?
Prolongation of intravaginal ejaculatory latency time (IELT) (time frame: 1 month and 3 months). The study lists 3 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 22 Jan 2025.