Safety and Efficacy of Botulinum Toxin-A Injection Into Ischiocavernosus Muscle for Premature Ejaculation

NCT06851598 | Active Not Recruiting Phase 2

• 1 other identifier: Botox in premature ejaculation
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this work is to assess the efficacy and safety of Botulinum toxin - A injection into ischiocavernosus muscle in treatment of primary premature ejaculation.

Conditions

Premature Ejaculation

Outcome Measures

Primary Outcomes (1)

• IELT(intravaginal ejaculatory latency time) twice weekly

  With phone stopwatch in seconds twice weekly

  3 Weeks before and 3 weeks after injection

Study Arms (3)

Group A

EXPERIMENTAL

Drug: 25 units botox

Group B

EXPERIMENTAL

Drug: 50 units Botox

Group C

EXPERIMENTAL

Drug: 75 units Botox

Interventions

25 units botox DRUG

25 units of botox injection into ischiocavernosus muscle

Group A

50 units Botox DRUG

50 Units botox injection into ischiocavernosus muscle

Group B

75 units Botox DRUG

75 units botox injection into ischiocavernosus muscle

Group C

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients with primary (lifelong) PE, with Ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration according to The International Society for Sexual Medicine (ISSM) In August 2014.
• \_2. Being married for at least 4 months, and in a stable relationship with regular sexual intercourse at least twice per week with a cooperative female partner.
• \. Normal erectile function.
• \. Age 18-65 years.

You may not qualify if:

• \. Erectile dysfunction or other Andrological disorders e.g., Cryptorchidism, Peyronie's disease and 3rd degree varicocele. 2. Major psychiatric or psychological illness. 3. Chronic medical disorders that may limit the usage of Botulinum toxin - A such as myasthenia gravis. 4. Men receiving medications that could affect ejaculatory function e.g., Antidepressants and antihypertensive. 5. Age less than 18 or more than 65.

Sponsors & Collaborators

• Abdallah Mohamed Abdallah Mohamed Elgendy: lead

Study Sites (1)

Faculty of Medicine, Al-Azhar University

Cairo, Egypt

Location

MeSH Terms

Conditions

Premature Ejaculation

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Abdelraouf Elmohsen, Professor

  Dermatology, Venereology and Andrology Faculty of Medicine, Al-Azhar University

  STUDY CHAIR

• Ahmed Elshahid, Professor

  Dermatology, Venereology and Andrology Faculty of Medicine, Al-Azhar University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Abdallah Elgendy

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 28, 2025
• Study Start: July 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: February 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

EG (1)