To study the results of pelvic floor physiotherapy for premature ejaculation.
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
I. intravaginal ejaculatory latency time (IELT), measured by a stopwatch
Secondary outcome
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
Background summary
Current treatment choices for premature ejaculation include behaviourally
oriented sex therapy including the well-known stop-start and squeeze techniques
for improving ejaculatory control, local anaesthetics and oral pharmacotherapy
involving the off-label use of common antidepressants. However, these treatment
approaches entail significant drawbacks that limit their acceptance by patients
and their large-scale use. With respect to these therapies one of the main
problems is that patients, and particularly their female partners, often
experience these interventions as mechanical and/or technical interference with
sensuality and eroticism, requiring the couple to interrupt sexual activity.
Study objective
To study the results of pelvic floor physiotherapy for premature ejaculation.
Study design
Observational pilot
Study burden and risks
There are no medical risks. If the results of pelvic floor physiotherapy would
be zero, one could say that expliciting one's sexual life may be a
psychological burden.
Hanzeplein 1
9700 RB Groningen
NL
Hanzeplein 1
9700 RB Groningen
NL
Listed location countries
Age
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 < 60 seconds.
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30266.042.09 |