Home » Trials » SLCTR/2013/004


A study to assess the impact of “Stop-Start technique” on sexual satisfaction in persons affected by premature ejaculation

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SLCTR Registration Number

SLCTR/2013/004


Date of Registration

20 Jan 2013

The date of last modification

Mar 03, 2019


Trial Status



Application Summary


Scientific Title of Trial

A study to assess the impact of “Stop-Start technique” on sexual satisfaction in persons affected by premature ejaculation


Public Title of Trial

A study on “Stop-Start technique” on sexual satisfaction in persons affected by premature ejaculation


Disease or Health Condition(s) Studied

Premature ejaculation


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

None


Any other number(s) assigned to the trial and issuing authority

P216/12/2012 (Ethics Review Committee of the Faculty of Medicine, University of Kelaniya)


Trial Details


What is the research question being addressed?

Does a behavioural intervention with the stop-start technique improve sexual satisfaction in persons with premature ejaculation?


Type of study

Interventional


Study design

Allocation

Single arm study


Masking

Masking not used


Control

Uncontrolled


Assignment

Single


Purpose

Treatment


Study Phase

Not Available


Intervention(s) planned

Premature ejaculation (PE) will be assessed at baseline using the internationally validated “Premature Ejaculatory Diagnostic Tool” questionnaire. Participants with PE will be provided health education and behavioural intervention using the stop start technique.


Inclusion criteria

  1. Males 2. Citizens of Sri Lanka. 3. Age between 30 - 70yrs. 4. Heterosexually active, in a stable relationship and have the opportunity to engage in sexual activity during the 6 months prior to the study. 5. Visiting the General Practice Clinic as a patient or a person accompanying a patient. 6. Able to read and understand English or Sinhala

Exclusion criteria

  1. Refusal to take part in the study. 2. No heterosexual activity during the past 6 months. 3. Persons who are only able to read and understand Tamil. 4. Being interviewed at a previous visit during the study.


Primary outcome(s)

1.

Improvement of sexual satisfaction as indicated on a visual analogue scale.

[

At baseline and after 2 months

]

Secondary outcome(s)

1.

None

[

None

]

Target number/sample size

40 (approximately


Countries of recruitment

Sri Lanka


Anticipated start date

2013-01-21


Anticipated end date

2013-03-21


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

None


Regulatory approvals



State of Ethics Review Approval


Status

Approved


Date of Approval

2012-12-12


Approval number

P216/12/2012


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Kelaniya
Institutional Address:PO Box 6, Thalagolla Road, Ragama Sri Lanka
Telephone:+94-11-2961267
Email: erckelaniya@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. C M A Anthony .
PG trainee in Family Medicine
374, Galle Road, Colombo 3
0112575165
0773555963

cmaanthony@hotmail.com

Contact Person for Public Queries

Prof. A L P de S Seneviratne
Professor in Family Medicine / Head of Department of Family Medicine, Faculty of Medical Sciences, University of Sri Jayawardanapura
Family Medical Clinic, 241/1, Galle Road, Ratmalana

071-426-8861

alprs@eureka.lk


Primary study sponsor/organization

Dr. C M A Anthony .
PG trainee in Family Medicine
374, Galle Road, Colombo 3
0773555963, 0112575165

cmaanthony@hotmail.com

Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description


Study protocol available


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results