Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-100
SponsorBoston Medical Group
About this trial
The objective of this clinical trial is to evaluate the effectiveness of pelvic floor therapy for the management of erectile dysfunction and premature ejaculation in patients with erectile dysfunction and premature ejaculation. The main question to answer is:
What is the effectiveness of pelvic floor therapy (electrostimulation, biofeedback, and therapeutic exercise) for the treatment of patients with erectile dysfunction and or premature ejaculation?
Patients will:
* Have an initial consultation of pelvic floor rehabilitation before therapy. * Be given pelvic floor therapy. * Have a secondary consultation of pelvic floor rehabilitation after therapy.
Three intervention groups will be included: Group 1: Patients with premature ejaculation Group 2: Patients with erectile dysfunction Group 3: Patients with erectile dysfunction and premature ejaculation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men over 18 years of age
Erectile dysfunction or premature ejaculation for at least 6 months
Sexual activity with a heterosexual partner at least once a week
Signing of informed consent before the start of the study
Disqualifiers
Pharmacological treatment for erectile dysfunction or premature ejaculation in the last 3 months
Erection Hardness Score (EHS) greater than 3 for patients with erectile dysfunction
History of hypogonadism or suspected hypogonadism due to Aging Males Symptoms (AMS) score greater than 36 for patients with erectile dysfunction
History of pelvic radiotherapy
Trial design
Design model
Parallel
Treatments tested in this trial
Therapeutic exercises
BehavioralRecognition of the pelvic area, respiratory management, lumbo-pelvic mobilization, discrimination of abdomino-pelvic contraction and myofascial release techniques.
Perineal electromyographic biofeedback
DeviceFree muscle work and gross motor coordination:
Electrical stimulation
DeviceMuscular proprioceptive work: 50 Hz 300 µs
Treatment groups
66 Participants
are divided into 3 treatment groupsGroup A: Erectile DysfunctionExperimental treatment 3 interventions
Group B: Premature EjaculationExperimental treatment 3 interventions
Group C: Premature Ejaculation + Erectile DysfunctionExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Change in baseline intravaginal latency time (IVLT)
Change in baseline intravaginal latency time (IVLT) at the end of therapy. (Groups 1,3)
Time frame
12 weeks2
Change in International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score
International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score change at the end of therapy. (Groups 2,3)
Time frame
12 weeksSecondary outcomes
1
Change in baseline intravaginal latency time (IVLT) at follow-up
Change in IVLT at 3 and 6 months of follow-up. (Groups 1,3)
Time frame
3 and 6 months of follow-up.2
Change Premature Ejaculation Perfil (PEP) score
Change in baseline PEP score at the end of therapy, 3 and 6 months of follow-up. (Groups 1,3)
Time frame
12 weeks, 3 and 6 months follow-up.3
Change in Premature Ejaculation Diagnosis Tool (PEDT) questionnnaire score
Change in baseline PEDT questionnaire score at the end of therapy, 3 and 6 months follow-up. (Groups 1,3)
Time frame
12 weeks, 3 and 6 months follow-up.4
Change Intracavity Assessment
Change in the parameters of the baseline Intracavity Assessment at the end of therapy, 3 and 6 months follow-up.
Time frame
12 weeks, 3 and 6 months follow-up.Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Boston Medical Group ColombiaRecruiting11022, Bogotá, Cundinamarca
Colombia
ColombiaSponsors and contacts
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Source ClinicalTrials.gov