Premature EjaculationNCT07236632
Hyaluronic Acid vs Botulinum Toxin Injection in Treatment of Lifelong Drug-Resistant Premature Ejaculation: Randomized Study
A study testing Botulinum toxin type A and Hyaluronic acid in people with Premature Ejaculation, run by Benha University.
Trial summary
Premature ejaculation (PE) is one of the most common male sexual dysfunctions, often resistant to conventional pharmacological and behavioral treatments. This randomized clinical trial aims to compare the safety and efficacy of two minimally invasive treatment options - hyaluronic acid (HA) injection into the glans… Read more about this study
- Who is it for?
- Ages 22 to 45 years, men only
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- Botulinum toxin type A and Hyaluronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Adult male patients aged 22 to 45 years.
- Sexually active and in a stable heterosexual relationship.
- Circumcised.
- Able to understand and comply with study procedures and follow-up visits.
- Diagnosed with lifelong drug-resistant premature ejaculation, defined as persistent ejaculation within one minute of penetration despite prior pharmacologic or behavioral therapy.
- Normal serum total testosterone, prolactin, and thyroid-stimulating hormone levels.
- Willing to provide written informed consent.
Who cannot join
- Presence or history of erectile dysfunction or other sexual or ejaculatory disorders such as retrograde ejaculation or acquired premature ejaculation.
- History of acute or chronic prostatitis.
- Any debilitating medical condition including hepatic failure, renal failure, or uncontrolled diabetes mellitus.
- Previous pelvic or spinal surgery.
- Prior chemotherapy or radiotherapy.
- Use of antipsychotic or neuroactive medications that may affect ejaculation.
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- History of substance abuse or current drug dependence.
- Presence of penile prosthesis, penile deformity, or anatomic abnormalities of the glans or shaft.
- Known hypersensitivity or allergy to botulinum toxin or hyaluronic acid preparations.
- Any condition that, in the investigator's opinion, may interfere with the safety or evaluation of the study treatment.
About this study
Official title: Hyaluronic Acid Versus Botox Injection in Treatment of Life Long Drug Resistant Premature Ejaculation. Which is Better? Randomized Study
Premature ejaculation (PE) is one of the most common male sexual dysfunctions, often resistant to conventional pharmacological and behavioral treatments. This randomized clinical trial aims to compare the safety and efficacy of two minimally invasive treatment options - hyaluronic acid (HA) injection into the glans penis versus botulinum toxin type A injection into the bulbospongiosus muscle - in men with lifelong drug-resistant premature ejaculation. Eighty participants will be randomly assigned in a 1:1 ratio to receive either HA or botulinum toxin injection. The primary outcome is change in intravaginal ejaculatory latency time (IELT). Secondary outcomes include changes in Premature Ejaculation Diagnostic Tool (PEDT), Arabic Index of Premature Ejaculation (AIPE) scores, Premature Ejaculation Profile (PEP), patient satisfaction, and treatment-related adverse events during a 12-month follow-up period.
- Conditions
- Premature Ejaculation
- Being tested
- Botulinum toxin type A, Hyaluronic acid
- Keywords
- Hyaluronic Acid, Botulinum Toxins, Ejaculation, Glans Penis, Bulbospongiosus Muscle, Intradermal Injections, Drug Resistance
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type A will be reconstituted by diluting 100 units in 10 milliliters of sterile normal saline. Using ultrasound guidance, 5 milliliters will be injected into each side of the bulbospongiosus muscle through a single puncture site while the patient is in the lithotomy position. The aim is to achieve even distribution of the toxin within the muscle fibers to reduce muscular contractions associated with ejaculation.
Hyaluronic acidDrug
Two milliliters of 3.5 percent micronized hyaluronic acid gel will be injected into the dermis of the glans penis using the Fanning Technique. The injection will be performed through a single puncture site with a 27-gauge needle, advancing from the tip of the glans toward the coronal sulcus to distribute the gel evenly. Topical anesthetic cream containing lidocaine and prilocaine will be applied for 30 minutes before the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin Injection Group | Experimental | Participants in this group will receive intramuscular injection of botulinum toxin type A into the bulbospongiosus muscle. A total dose of 100 units of botulinum toxin type A, diluted in 10 milliliters of normal saline, will be administered under ultrasound guidance. The injection will be divided equally, with 5 milliliters injected on each side of the muscle to ensure even distribution across most muscle fibers. The procedure will be performed under aseptic conditions with patients in the lithotomy position. Receives: Drug: Botulinum toxin type A |
| Hyaluronic Acid Injection Group | Experimental | Participants in this group will receive injection of hyaluronic acid into the glans penis using the Fanning Technique. Two milliliters of 3.5 percent micronized hyaluronic acid gel will be injected through a single puncture site using a 27-gauge needle. The injection will start from the tip of the glans and proceed toward the coronal sulcus to achieve uniform distribution of the gel. The procedure will be performed under local anesthesia with application of topical lidocaine and prilocaine cream for 30 minutes prior to injection. Receives: Drug: Hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intravaginal ejaculatory latency time
The duration from vaginal penetration to ejaculation will be recorded using a stopwatch by the patient's partner. The median intravaginal ejaculatory latency time will be calculated for each participant from several intercourse attempts. The change in latency time after treatment compared with baseline will be used to assess treatment efficacy.
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention
Secondary outcomes (4)
Change in Premature Ejaculation Diagnostic Tool (PEDT) score
The Premature Ejaculation Diagnostic Tool questionnaire will be used to evaluate changes in ejaculatory control and distress levels. Higher scores indicate greater severity.
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention
Change in Arabic Index of Premature Ejaculation (AIPE) score
The Arabic Index of Premature Ejaculation questionnaire will assess subjective improvement in control, satisfaction, and distress related to ejaculation. Higher scores reflect better control and lower distress.
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention
Change in Premature Ejaculation Profile (PEP) score
The Premature Ejaculation Profile will be used to evaluate treatment-related improvement across four domains: perceived control, personal distress, interpersonal difficulty, and sexual satisfaction.
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention
Patient satisfaction score
Participants will rate overall satisfaction with the procedure using a four-point scale (0 = dissatisfied, 1 = slightly satisfied, 2 = satisfied, 3 = very satisfied).
Measured: 1 month, 3 months, 6 months, and 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start15 Dec 2025 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
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.
- More trials run by Benha 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
- Model description
- Two-arm randomized trial comparing botulinum toxin A injection into the bulbospongiosus muscle vs hyaluronic acid injection into the glans (Fanning Technique) in lifelong drug-resistant premature ejaculation (PE).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maher Wahba, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236632
- Sponsor's protocol ID
- MD 9-5-2025
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in this study will be made available to qualified researchers upon reasonable request. Shared data will include demographic characteristics, intervention details, and outcome measures related to intravaginal ejaculatory latency time, questionnaire scores, and adverse events. No information that could identify participants will be released.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyaluronic Acid Versus Botox Injection in Treatment of Life Long Drug Resistant Premature Ejaculation. Which is Better? Randomized Study
- ClinicalTrials.gov ID
- NCT07236632
- Acronym / sponsor ID
- MD 9-5-2025
- Conditions
- Premature Ejaculation
- Keywords
- Hyaluronic Acid, Botulinum Toxins, Ejaculation, Glans Penis, Bulbospongiosus Muscle, Intradermal Injections, Drug Resistance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 19 Nov 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.
Premature ejaculation (PE) is one of the most common male sexual dysfunctions, often resistant to conventional pharmacological and behavioral treatments. This randomized clinical trial aims to compare the safety and efficacy of two minimally invasive treatment options - hyaluronic acid (HA) injection into the glans penis versus botulinum toxin type A injection into the bulbospongiosus muscle - in men with lifelong drug-resistant premature ejaculation. Eighty participants will be randomly assigned in a 1:1 ratio to receive either HA or botulinum toxin injection. The primary outcome is change in intravaginal ejaculatory latency time (IELT). Secondary outcomes include changes in Premature Ejaculation Diagnostic Tool (PEDT), Arabic Index of Premature Ejaculation (AIPE) scores, Premature Ejaculation Profile (PEP), patient satisfaction, and treatment-related adverse events during a 12-month follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm randomized trial comparing botulinum toxin A injection into the bulbospongiosus muscle vs hyaluronic acid injection into the glans (Fanning Technique) in lifelong drug-resistant premature ejaculation (PE).
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin Injection Group | Experimental | Drug: Botulinum toxin type AParticipants in this group will receive intramuscular injection of botulinum toxin type A into the bulbospongiosus muscle. A total dose of 100 units of botulinum toxin type A, diluted in 10 milliliters of normal saline, will be administered under ultrasound guidance. The injection will be divided equally, with 5 milliliters injected on each side of the muscle to ensure even distribution across most muscle fibers. The procedure will be performed under aseptic conditions with patients in the lithotomy position. |
| Hyaluronic Acid Injection Group | Experimental | Drug: Hyaluronic acidParticipants in this group will receive injection of hyaluronic acid into the glans penis using the Fanning Technique. Two milliliters of 3.5 percent micronized hyaluronic acid gel will be injected through a single puncture site using a 27-gauge needle. The injection will start from the tip of the glans and proceed toward the coronal sulcus to achieve uniform distribution of the gel. The procedure will be performed under local anesthesia with application of topical lidocaine and prilocaine cream for 30 minutes prior to injection. |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adult male patients aged 22 to 45 years.
- Sexually active and in a stable heterosexual relationship.
- Circumcised.
- Able to understand and comply with study procedures and follow-up visits.
- Diagnosed with lifelong drug-resistant premature ejaculation, defined as persistent ejaculation within one minute of penetration despite prior pharmacologic or behavioral therapy.
Key exclusion criteria (10 listed)
- Presence or history of erectile dysfunction or other sexual or ejaculatory disorders such as retrograde ejaculation or acquired premature ejaculation.
- History of acute or chronic prostatitis.
- Any debilitating medical condition including hepatic failure, renal failure, or uncontrolled diabetes mellitus.
- Previous pelvic or spinal surgery.
- Prior chemotherapy or radiotherapy.
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 |
|---|---|---|
| Botulinum toxin type ABotulinum toxin type A will be reconstituted by diluting 100 units in 10 milliliters of sterile normal saline. Using ultrasound guidance, 5 milliliters will be injected into each side of the bulbospongiosus muscle through a single puncture site while the patient is in the lithotomy position. The aim is to achieve even distribution of the toxin within the muscle fibers to reduce muscular contractions associated with ejaculation. | Drug | Botulinum Toxin Injection Group |
| Hyaluronic acidTwo milliliters of 3.5 percent micronized hyaluronic acid gel will be injected into the dermis of the glans penis using the Fanning Technique. The injection will be performed through a single puncture site with a 27-gauge needle, advancing from the tip of the glans toward the coronal sulcus to distribute the gel evenly. Topical anesthetic cream containing lidocaine and prilocaine will be applied for 30 minutes before the procedure. | Drug | Hyaluronic Acid Injection Group |
Primary outcome
Change in intravaginal ejaculatory latency time
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention
The duration from vaginal penetration to ejaculation will be recorded using a stopwatch by the patient's partner. The median intravaginal ejaculatory latency time will be calculated for each participant from several intercourse attempts. The change in latency time after treatment compared with baseline will be used to assess treatment efficacy.
4 secondary outcomes
Change in Premature Ejaculation Diagnostic Tool (PEDT) score
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention
Change in Arabic Index of Premature Ejaculation (AIPE) score
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention
Change in Premature Ejaculation Profile (PEP) score
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention
Patient satisfaction score
Time frame: 1 month, 3 months, 6 months, and 12 months after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in this study will be made available to qualified researchers upon reasonable request. Shared data will include demographic characteristics, intervention details, and outcome measures related to intravaginal ejaculatory latency time, questionnaire scores, and adverse events. No information that could identify participants will be released.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum toxin type A and Hyaluronic acid in people with Premature Ejaculation, run by Benha University.
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 7 inclusion and 10 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: opening soon, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Change in intravaginal ejaculatory latency time (time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention). 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 19 Nov 2025.