Premature (Early) Ejaculation
Conditions
Keywords
premature ejaculation, Botulinum toxin type A, intravaginal Ejaculatory Latency TIME, Sexual Dysfunction
Brief summary
Premature ejaculation is a common sexual condition that can cause distress for men and their partners. Different treatments are available, but some men do not respond well to standard therapies. This study was designed to evaluate whether injecting botulinum toxin type A into two areas of the penis and surrounding muscles can help delay ejaculation in men with lifelong premature ejaculation. Participants were randomly assigned to receive either botulinum toxin injections or placebo injections. The study evaluated ejaculation time, sexual satisfaction, and quality of life over a follow-up period of six months. Safety and possible side effects were also monitored during the study.
Detailed description
Lifelong premature ejaculation is a common male sexual disorder characterized by ejaculation that occurs with minimal sexual stimulation and causes personal distress. Although several pharmacological and behavioral treatment options are available, a subset of patients does not achieve satisfactory results or experiences side effects. Botulinum toxin type A has neuromodulatory properties that may influence ejaculatory reflex pathways. This randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the efficacy and safety of dual-site botulinum toxin type A injection in men with lifelong premature ejaculation. Eligible participants were randomly assigned to receive either botulinum toxin type A or placebo injections. Injections were administered into the bulbospongiosus muscle and the glans penis under standardized conditions. Participants were followed for six months after treatment. The primary outcome measure was intravaginal ejaculatory latency time. Secondary outcomes included patient-reported measures of sexual satisfaction, perceived control over ejaculation, and quality of life. Safety outcomes and adverse events were monitored throughout the study period
Interventions
DRUGBoNT-A
participants were randomly assigned to one of two parallel groups to receive either Botulinum toxin type A injection or placebo injections( normal saline ) and were followed prospectively also the dual site injection is new
injection of equivalent amount of normal saline by same technique and mechanism into the bulbospongiosus muscle and the glans penis
Sponsors
Al Mouwasat Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
participants ,care providers ,investigators ,and outcome assessors were blinded to treatment assignment
Intervention model description
participants were randomly assigned to one of two parallel groups to receive either botulinum toxin type A injection or placebo injections and were followed prospectively
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
male participants aged 20 years or older . diagnosis with lifelong premature ejaculation, in a stable heterosexual relationship for at least 6 months prior to enrollment, engaged in vaginal intercourse during the study period, willing and able to provide written informed consent -
Exclusion criteria
presence of acquired premature ejaculation, history of erectile dysfunction require treatment , current use of medication known to affect ejaculation or sexual function ,previous treatment with botulinum toxin for sexual dysfunction ,history of sever neurological or psychatricor endocrine disorders affection sexual function , active genital infection or penile anatomical abnormalities , hypersensitivity to botulinum toxin ,mythenia gravis \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intravaginal ejaculatory latency time (IELT ) | Baseline to 6 months after intervention | intravaginal ejaculatory latency time was defined as the time from vaginal penetrationto ejaculation . measured by stopwatch in minutes or seconds |
| Intravaginal Ejaculatory Latency Time ( IELT) | Baseline to 6 months after intervention | (IELT) was defined as the time from vaginal penetration to ejaculation, measured in minutes using a stopwatch |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sexual satisfaction | Baseline to 6 months after intervention | sexual satisfaction was assessed using a validated patient-reported questionnaire completed by participants during the study follow up period which reflect quality of life |
Countries
Saudi Arabia
Contacts
PRINCIPAL_INVESTIGATORHaitham Abdalla Shello, MD
AL MOUWASAT HOSPITAL ,RIYADH SAUDI ARABIA
Outcome results
None listed