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Trial record 2 of 3 for:    boston medical group | Premature Ejaculation

Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04207723
Recruitment Status : Not yet recruiting
First Posted : December 23, 2019
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Medical Group

Brief Summary:

Objective: Evaluate the effectiveness and safety of transcutaneous electrostimulation of the posterior tibial nerve alone and combined with standard pharmacological treatment, in men with primary premature ejaculation, compared to standard pharmacological treatment.

Patients and methods: Randomized controlled clinical trial. Patients diagnosed with premature ejaculation attending Boston Medical Group clinics in Colombia and Spain will be included. Participants will be assigned by randomization to one of three treatment groups:

  • Group 1: Tens + placebo drug therapy
  • Group 2: Standard treatment (paroxetine 20 mg) + placebo therapy
  • Group 3: Tens therapy + standard treatment (paroxetine mg)

The change in intravaginal latency time measured with the couple's sustained stopwatch, the change in the PEDT scale, the perception of the change in their initial condition after treatment (Global Clinical impression of change scale), and the change in different domains of the EP (PEP Scale - Profile Ejaculation Premature) at the end of treatment (week 12) and at three months of follow-up (week 24).


Condition or disease Intervention/treatment Phase
Premature Ejaculation Other: Transcutaneous posterior tibial nerve stimulation Drug: Paroxetine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation Treatment
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: TENS Therapy
Tens therapy + placebo drug therapy
Other: Transcutaneous posterior tibial nerve stimulation
Three (3) sessions per week per twelve (12) consecutive weeks, with a duration of 30 minutes each, with the application of 20 Hertz with a pulse amplitude of 200 MI sec. in each session. The intensity will be applied individually for each patient depending on the tolerance of the individual.

Sham Comparator: Control
Standard treatment (paroxetine 20 mg) + sham therapy
Drug: Paroxetine
paroxetine 20 mg / day taken in the morning hours, per 12 weeks.

Experimental: Combination therapy
Tens therapy + standard treatment (paroxetine 20 mg)
Other: Transcutaneous posterior tibial nerve stimulation
Three (3) sessions per week per twelve (12) consecutive weeks, with a duration of 30 minutes each, with the application of 20 Hertz with a pulse amplitude of 200 MI sec. in each session. The intensity will be applied individually for each patient depending on the tolerance of the individual.




Primary Outcome Measures :
  1. Intravaginal latency time at week 12 [ Time Frame: Week 12 ]
    Mean change in intravaginal latency time, measured with a stopwatch by the couple, at week 12.


Secondary Outcome Measures :
  1. Change in Premature Ejaculation Diagnostic Tool (PEDT) questionnaire score [ Time Frame: weeks 12 and 24 ]
    Patients with a change in Premature Ejaculation Diagnostic Tool questionnaire score at weeks 12 and 24. A score of 11 or more suggests PE. A score of 9 or 10 may be found in men with PE; it is a "borderline" score. A score of 8 or less suggests that a man does not have PE. The minimum and maximum values are 0 and 20, respectively.

  2. Clinical improvement [ Time Frame: weeks 12 and 24 ]
    Three-fold increase in intravaginal ejaculatory latency time



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary premature ejaculation as defined by the International Society for Sexual Medicine (ISSM-International Society for Sexual Medicine) (30): a) ejaculation occurs always or almost always within the first minute after penetration, b) disability to delay ejaculation in all or almost all penetrations, c) negative personal consequences are generated, such as stress, discomfort, frustration and / or avoidance of sexual intimacy.
  • Age equal to or greater than 18 years.
  • PEDT score greater than 11.
  • Stable heterosexual relationship of at least 6 months with the interest of maintaining it for at least the duration of the study.
  • Sexual activity at least once a week.
  • Minimum chronicity of PE of 6 months.
  • Voluntary participation in the study.
  • Signature of informed consent prior to participation in the study.

Exclusion Criteria:

  • IIEF-EF score greater than 25.
  • Clinically significant comorbidity: cardiovascular, hepatic, thromboembolic, neurological, locomotive, endocrine, oncological, renal or rheumatologic.
  • History of retroperitoneal surgery, radiotherapy or multiple sclerosis.
  • History of mental illness: depression, anxiety, suicidal behavior, bipolar disorder, agoraphobia, dysthymia, social phobia, obsessive compulsive disorder, post-traumatic stress, psychiatric disorder, referred by the patient or by the use of a medication for one of these terms.
  • Consumption of medications that affect ejaculatory control such as psychiatric medications, opioid analgesics, alpha blockers.
  • Treatment for PD in the last 3 months.
  • Treatment for epileptic syndromes or Parkinson's disease.
  • Use of pacemaker or cardiac defibrillator.
  • Skin lesions in the electrode placement area.
  • Abuse or dependence on piscoactive substances: alcohol, hallucinogenic drugs.
  • Couple in a state of pregnancy.
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Responsible Party: Boston Medical Group
ClinicalTrials.gov Identifier: NCT04207723    
Other Study ID Numbers: 005
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Premature Ejaculation
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors