Physical therapy for premature ejaculation - a pilot study

• Conditions: ejaculatio praecox; rapid ejaculation; 10013356

• Registration Number: NL-OMON32912
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 20

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>I. intravaginal ejaculatory latency time (IELT), measured by a stopwatch</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>II. ejaculatory control (PEP questionnaire)<br /><br>III. sexual satisfaction (SQOL-M questionnaire)<br /><br>IV. pelvic floor activity (Male Pelvic Floor Symptom Score questionnaire) and<br /><br>V. partner reported outcome (the Female Sexual Function Index questionnaire and<br /><br>Female Sexual Distress Scale)<br /><br>at 8 weekly intervals up till 6 months<br /><br>VI. registration of pelvic floor activity (with an anal pressure probe), pre-<br /><br>and post-treatment</p><br>