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TPTNS for Treating Patients With 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03204890
Recruitment Status : Completed
First Posted : July 2, 2017
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Medical Group

Tracking Information
First Submitted Date  ICMJE June 28, 2017
First Posted Date  ICMJE July 2, 2017
Last Update Posted Date February 4, 2019
Actual Study Start Date  ICMJE June 14, 2017
Actual Primary Completion Date January 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2017)
Clinical improvement [ Time Frame: Three months after completion. ]
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2017)
  • Change in the basal PDET score [ Time Frame: Three months after completion. ]
  • Magnitude of the change in the PEDT score [ Time Frame: Three months after completion. ]
  • Frequency and severity of adverse events [ Time Frame: During the therapy ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TPTNS for Treating Patients With Premature Ejaculation
Official Title  ICMJE Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS) for Treating Patients With Premature Ejaculation. Phase II Clinical Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Premature Ejaculation
Intervention  ICMJE Other: Transcutaneous Posterior Tibial Nerve Stimulation
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.
Study Arms  ICMJE Experimental: TPTNS
Transcutaneous Posterior Tibial Nerve Stimulation
Intervention: Other: Transcutaneous Posterior Tibial Nerve Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2017)
26
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 30, 2018
Actual Primary Completion Date January 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03204890
Other Study ID Numbers  ICMJE BMGC-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Boston Medical Group
Study Sponsor  ICMJE Boston Medical Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: José P Saffon, Doctor Boston Medical Group
PRS Account Boston Medical Group
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP