Effectiveness and Safety of Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation Treatment

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Colombia
Boston Medical Group
RECRUITING
Bogotá
Contact Information
Primary
Carolina Sandoval, MSc
csandoval@bostonmedical.com.co
+573133920816
Backup
Hector Corredor, Md
hcorredor@bostonmedical.com.co
+573174317162
Time Frame
Start Date: 2020-07-15
Estimated Completion Date: 2025-09
Participants
Target number of participants: 120
Treatments
Experimental: TENS Therapy
Tens therapy + placebo drug therapy
Sham_comparator: Control
Standard treatment (paroxetine 20 mg) + sham therapy
Experimental: Combination therapy
Tens therapy + standard treatment (paroxetine 20 mg)
Related Therapeutic Areas
Sponsors
Leads: Boston Medical Group

This content was sourced from clinicaltrials.gov