NCT05964608

Brief Summary

Premature ejaculation involves not only sexual problems but also relationship and communication difficulties, and behavioral approaches to the treatment of premature ejaculation are promising.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 28, 2023

Completed
Last Updated

July 28, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

July 17, 2023

Last Update Submit

July 27, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Premature Ejaculation Diagnostic Tool (PEDT)

    it was developed by Symonds et al. (2007) to better define premature ejaculation for use in clinical studies, this is a 5-point Likert-type scale consisting of 5 items. The scale was adapted to Turkish by Serefoglu et al. (2009). The highest score that can be obtained from the scale is 20.0 and the lowest score is 0.0. Scores higher than 11 are defined as "PE", scores of 9-10 are defined as "possible PE", and scores of eight or less are defined as "no PE".

    six weeks

Secondary Outcomes (2)

  • Female Sexual Function Index (FSFI)

    six weeks

  • Sexual Quality of Life-Female (SQOL-F)

    six weeks

Study Arms (1)

Treatment group

EXPERIMENTAL

Pre-tests were applied to the men (Personal Information Form and PEDT) and their spouses (Personal Information Form, FSFI, and SQOL-F) just before the behavioral treatment was applied to the men in the treatment group. In the first interview with the men, the researchers delivered information about behavioral therapy and set therapy days and hours. Structured interviews, consisting of a total of 6 sessions, were held once every two weeks for men with premature ejaculation problems. Behavioral therapy took place once every two weeks for a total of six 45-minute sessions. The "stop-start technique" was the therapy used. Behavioral therapy interviews were conducted at the urology outpatient clinic of the hospital. Post-tests were administered to men with premature ejaculation (PEDT) and their spouses (FSFI and SQOL-F) immediately after the 6th session was completed.

Behavioral: Behavioral Therapy

Interventions

Structured interviews, consisting of a total of 6 sessions, were held once every two weeks for men with premature ejaculation problems. Behavioral therapy took place once every two weeks for a total of six 45-minute sessions. The "stop-start technique" was the therapy used. Behavioral therapy interviews were conducted at the urology outpatient clinic of the hospital. Post-tests were administered to men with premature ejaculation (PEDT) and their spouses (FSFI and SQOL-F) immediately after the 6th session was completed.

Treatment group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Willingness to participate
  • Having no communication barriers
  • Literacy
  • Age 18-45 years
  • Having no diagnosis of sexual dysfunctions
  • Having no medical illnesses (psychiatric diseases, pelvic anatomical disorder, post-menopause, etc.) that might affect the sexual function
  • Having a spouse diagnosed with premature ejaculation according to DSM-5 criteria
  • Having a spouse without any prior behavioral therapy for premature ejaculation
  • Being a man diagnosed with lifelong premature ejaculation according to the ISSM criteria.
  • Being married

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ECE

Gaziantep, 0027, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature EjaculationSexual Dysfunctions, Psychological

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Ejaculatory DysfunctionGenital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Kazım Doğan, Dr.

    Istinye University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

July 17, 2023

First Posted

July 28, 2023

Study Start

June 30, 2021

Primary Completion

September 30, 2021

Study Completion

March 15, 2022

Last Updated

July 28, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations