ejaculatio praecox rapid ejaculation
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Subjects aged > 18 years Subjects and partner have provided written informed consent. Subjects must be in a stable, monogamous, heterosexual relationship with the same partner for at least 6 months. Subjects must be insured for physiotherapy. The male subjects must be in good general health with no clinically relevant abnormalities as phimosis and prostatitis, normal complete blood count, normal blood chemistry, normal total testosterone. Subjects and their partner must be prepared to attempt intercourse on a regular basis and at least once a week. Subjects must meet criteria for diagnosis of PE using a multivariate definition of PE (McMahon, 2008) and a baseline threshold intra-vaginal ejaculatory latency time of
Exclusion criteria
Exclusion criteria: The male subjects must not have used investigational drugs within the past 1 month; they also must not have pelvic floor physiotherapy within the past. The male subject must not have a history of pelvic/retroperitoneal surgery or radiotherapy, multiple sclerosis, cerebro-vascular accident, spinal cord injury or prostatitis, which may be associated with the onset of PE symptoms and considered a potential cause of PE. The male subject must not have a current or past history of depressive or anxiety disorder, dysthymia, suicidality, (hypo) manic episode, panic disorder, agoraphobia, social phobia, obsessive-compulsive disorder, posttraumatic stress disorder, or psychotic disorders. The male subject with a current or past history of alcohol abuse and dependence, non-alcohol psychoactive substance use disorder The male subject may not use any drug that may influence IELT (selective serotonine reuptake inhibitors, monoamineoxydase inhibitors, antipsychotics, cimetidine, phenobarbital, phenytoin, tramadol, St. John*s Wort and local topical anaesthetics Male subject with hypoactive sexual desire, retrograde, delayed or absent orgasm or ejaculation or erectile dysfunction The male subject with hypogonadism, hyperprolactinemia, or untreated or insufficiently treated hypothyroidism/hyperthyroidism The female subject with clinically significant sexual dysfunctions including hypoactive sexual desire and dyspareunia, which may significantly impact the sexual relationship
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| I. intravaginal ejaculatory latency time (IELT), measured by a stopwatch | — |
Secondary
| Measure | Time frame |
|---|---|
| II. ejaculatory control (PEP questionnaire) III. sexual satisfaction (SQOL-M questionnaire) IV. pelvic floor activity (Male Pelvic Floor Symptom Score questionnaire) and V. partner reported outcome (the Female Sexual Function Index questionnaire and Female Sexual Distress Scale) at 8 weekly intervals up till 6 months VI. registration of pelvic floor activity (with an anal pressure probe), pre- and post-treatment | — |
Countries
Netherlands