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Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation

Primary Purpose

Premature Ejaculation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcutaneous posterior tibial nerve stimulation
Paroxetine
Sponsored by
Boston Medical Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Ejaculation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Sham Comparator

    Experimental

    Arm Label

    TENS Therapy

    Control

    Combination therapy

    Arm Description

    Tens therapy + placebo drug therapy

    Standard treatment (paroxetine 20 mg) + sham therapy

    Tens therapy + standard treatment (paroxetine 20 mg)

    Outcomes

    Primary Outcome Measures

    Intravaginal latency time at week 12
    Mean change in intravaginal latency time, measured with a stopwatch by the couple, at week 12.

    Secondary Outcome Measures

    Change in Premature Ejaculation Diagnostic Tool (PEDT) questionnaire score
    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.
    Clinical improvement
    Three-fold increase in intravaginal ejaculatory latency time

    Full Information

    First Posted
    December 19, 2019
    Last Updated
    December 27, 2019
    Sponsor
    Boston Medical Group
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04207723
    Brief Title
    Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation
    Official Title
    Effectiveness and Safety of Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2020 (Anticipated)
    Primary Completion Date
    December 2021 (Anticipated)
    Study Completion Date
    December 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boston Medical Group

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premature Ejaculation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TENS Therapy
    Arm Type
    Experimental
    Arm Description
    Tens therapy + placebo drug therapy
    Arm Title
    Control
    Arm Type
    Sham Comparator
    Arm Description
    Standard treatment (paroxetine 20 mg) + sham therapy
    Arm Title
    Combination therapy
    Arm Type
    Experimental
    Arm Description
    Tens therapy + standard treatment (paroxetine 20 mg)
    Intervention Type
    Other
    Intervention Name(s)
    Transcutaneous posterior tibial nerve stimulation
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Paroxetine
    Intervention Description
    paroxetine 20 mg / day taken in the morning hours, per 12 weeks.
    Primary Outcome Measure Information:
    Title
    Intravaginal latency time at week 12
    Description
    Mean change in intravaginal latency time, measured with a stopwatch by the couple, at week 12.
    Time Frame
    Week 12
    Secondary Outcome Measure Information:
    Title
    Change in Premature Ejaculation Diagnostic Tool (PEDT) questionnaire score
    Description
    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.
    Time Frame
    weeks 12 and 24
    Title
    Clinical improvement
    Description
    Three-fold increase in intravaginal ejaculatory latency time
    Time Frame
    weeks 12 and 24

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Learn more about this trial

    Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation

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