Back to resultsTranscutaneous 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
About this trial
This is an interventional treatment trial for Premature Ejaculation
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.
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
NCT ID
NCT04207723
First Posted
December 19, 2019
Last Updated
December 27, 2019
Sponsor
Boston Medical Group
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
We'll reach out to this number within 24 hrs