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Physical therapy for premature ejaculation - a pilot study

Physical therapy for premature ejaculation - a pilot study - n.v.t.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON32912
Enrollment
20
Registered
2010-05-21
Start date
2010-01-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ejaculatio praecox rapid ejaculation

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime frame
I. intravaginal ejaculatory latency time (IELT), measured by a stopwatch

Secondary

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)