Back to resultsTPTNS for Treating Patients With Premature Ejaculation
Primary Purpose
Premature Ejaculation
Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Transcutaneous Posterior Tibial Nerve Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Premature Ejaculation
Eligibility Criteria
Inclusion Criteria:
- Over 18 years of age and less than 50 years of age with no cardiovascular risk factor other than age.
- Having been diagnosed with primary premature ejaculation according to the American Psychiatric Society's DSM 5 Diagnostic and Statistical Manual.
- Agreeing to participate and providing signed informed consent.
- Stable relationship for over 6 months, with frequent intercourse at least once per week.
Exclusion Criteria:
- Diagnosis of erectile dysfunction according to the IIFE 5 (score under 21).
- A PEDT score under 8.
- Use of treatment for premature ejaculation during the study or over the 6 months prior to beginning the study.
- Use of pacemaker or heart defibrillator.
- Epilepsy or convulsions
- Venous insufficiency (varices) or cutaneous wounds or injuries on the lower extremities.
- Congenital or acquired anatomical abnormalities of the penis.
- Taking medications that affect ejaculation control, including psychiatric medications, opioid analgesics and medications for pathologies of the prostate such as alpha blockers.
- Psychological or psychiatric disorders that prevent the patient from undergoing the treatment or recording the measurements as established.
- Difficulty going to the clinic 3 times per week as required by the protocol.
- Patients with precoital premature ejaculation.
- Use of barrier contraceptive methods or local anesthetics.
Sites / Locations
- Boston Medical Group Colombia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TPTNS
Arm Description
Transcutaneous Posterior Tibial Nerve Stimulation
Outcomes
Primary Outcome Measures
Clinical improvement
Proportion of patients with clinical improvement of premature ejaculation, defined as a tripling of the baseline time (without treatment), as measured by the IELT (intravaginal ejaculation latency time)
Secondary Outcome Measures
Change in the basal PDET score
Magnitude of the change in the PEDT score
Frequency and severity of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03204890
Brief Title
TPTNS for Treating Patients With Premature Ejaculation
Official Title
Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS) for Treating Patients With Premature Ejaculation. Phase II Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 14, 2017 (Actual)
Primary Completion Date
January 15, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)
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
Background: Transcutaneous posterior tibial nerve stimulation is an effective therapy for controlling urinary incontinence. Premature ejaculation (PE) and urinary incontinence are anatomically and physio-pathologically similar. Based on this, the use of this therapy is considered to be viable for the control of PE.
Objective: To evaluate the efficacy of transcutaneous posterior tibial nerve electrostimulation for the ejaculatory reflex.
Patients and Methods: Phase II clinical trial. Patients with a diagnosis of premature ejaculation who are treated at the Colombia Boston Medical Group clinic will be included. The participants will receive 3 transcutaneous posterior tibial nerve stimulation therapies per week for 12 weeks. The IELT and the PEDT scale will be evaluated on week 6, at the end of treatment and three months after completing the protocol.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TPTNS
Arm Type
Experimental
Arm Description
Transcutaneous Posterior Tibial Nerve Stimulation
Intervention Type
Other
Intervention Name(s)
Transcutaneous Posterior Tibial Nerve Stimulation
Intervention Description
Three (3) sessions per week for 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. In each session, it is normal to have plantar flexion of the foot and flexion of the first toe, and after the session and particularly during the first sessions there is the possibility of muscle pain, which should be tolerable.
Primary Outcome Measure Information:
Title
Clinical improvement
Description
Proportion of patients with clinical improvement of premature ejaculation, defined as a tripling of the baseline time (without treatment), as measured by the IELT (intravaginal ejaculation latency time)
Time Frame
Three months after completion.
Secondary Outcome Measure Information:
Title
Change in the basal PDET score
Time Frame
Three months after completion.
Title
Magnitude of the change in the PEDT score
Time Frame
Three months after completion.
Title
Frequency and severity of adverse events
Time Frame
During the therapy
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Over 18 years of age and less than 50 years of age with no cardiovascular risk factor other than age.
Having been diagnosed with primary premature ejaculation according to the American Psychiatric Society's DSM 5 Diagnostic and Statistical Manual.
Agreeing to participate and providing signed informed consent.
Stable relationship for over 6 months, with frequent intercourse at least once per week.
Exclusion Criteria:
Diagnosis of erectile dysfunction according to the IIFE 5 (score under 21).
A PEDT score under 8.
Use of treatment for premature ejaculation during the study or over the 6 months prior to beginning the study.
Use of pacemaker or heart defibrillator.
Epilepsy or convulsions
Venous insufficiency (varices) or cutaneous wounds or injuries on the lower extremities.
Congenital or acquired anatomical abnormalities of the penis.
Taking medications that affect ejaculation control, including psychiatric medications, opioid analgesics and medications for pathologies of the prostate such as alpha blockers.
Psychological or psychiatric disorders that prevent the patient from undergoing the treatment or recording the measurements as established.
Difficulty going to the clinic 3 times per week as required by the protocol.
Patients with precoital premature ejaculation.
Use of barrier contraceptive methods or local anesthetics.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José P Saffon, Doctor
Organizational Affiliation
Boston Medical Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Group Colombia
City
Bogotá
State/Province
Cundinamarca
ZIP/Postal Code
11022
Country
Colombia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
TPTNS for Treating Patients With Premature Ejaculation
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