Genitourinary Symptoms With Levonorgestrel Releasing Intrauterine Systems

May 14, 2013 updated by: murat ekin, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Genitourinary Symptoms in Women Using Levonorgestrel Releasing Intrauterine Systems

The main purpose of the study was to evaluate the efficacy of Levonorgestrel Releasing Intrauterine devices (LNR-IUD) on genitourinary symptoms in patients with abnormal uterine bleeding. The patients were asked urogenital distress inventory (UDI) (which includes; irritative symptoms, stress symptoms, obstructive discomfort) and incontinence impact questionnaire (IIQ) (which includes; physical activity, travel, social/relationships, emotional health)questionnaires in the day of application LNR-IUD and six months later this procedure. Statistical analyse will be performed to evaluate the changes in this time period.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34250
        • Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

15-55 aged women using levonorgestrel releasing intrauterine device for the treatment of menorrhagia or adenomyosis

Description

Inclusion Criteria:

  • women using levonorgestrel releasing intrauterine device for the treatment of menorrhagia or adenomyosis

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary frequency
Time Frame: 6 months
We think that the urinary frequency will be lesser after 6 months of the therapy.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
social activity
Time Frame: 6 months
We think that social activity will be better after reducing urinary symptoms
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

  • Study Chair: Murat Ekin, M.D., Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology
  • Principal Investigator: Cihan Kaya, M.D., Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology
  • Principal Investigator: Mehmet E Ayag, M.D., Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

November 15, 2012

First Submitted That Met QC Criteria

November 20, 2012

First Posted (Estimate)

November 21, 2012

Study Record Updates

Last Update Posted (Estimate)

May 15, 2013

Last Update Submitted That Met QC Criteria

May 14, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LN-IUSBDSK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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