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Genitourinary Symptoms With Levonorgestrel Releasing Intrauterine Systems

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01730300
First Posted: November 21, 2012
Last Update Posted: May 15, 2013
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.
Information provided by (Responsible Party):
murat ekin, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
  Purpose
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.

Condition
Lower Urinary Tract Symptoms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genitourinary Symptoms in Women Using Levonorgestrel Releasing Intrauterine Systems

Resource links provided by NLM:


Further study details as provided by murat ekin, Bakirkoy Dr. Sadi Konuk Research and Training Hospital:

Primary Outcome Measures:
  • Urinary frequency [ Time Frame: 6 months ]
    We think that the urinary frequency will be lesser after 6 months of the therapy.


Secondary Outcome Measures:
  • social activity [ Time Frame: 6 months ]
    We think that social activity will be better after reducing urinary symptoms


Enrollment: 60
Study Start Date: June 2012
Study Completion Date: May 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
15-55 aged women using levonorgestrel releasing intrauterine device for the treatment of menorrhagia or adenomyosis
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01730300


Locations
Turkey
Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology
Istanbul, Turkey, 34250
Sponsors and Collaborators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: murat ekin, Training Officer of Obstetrics and Gynecology Department M.D., Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier: NCT01730300     History of Changes
Other Study ID Numbers: LN-IUSBDSK
First Submitted: November 15, 2012
First Posted: November 21, 2012
Last Update Posted: May 15, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral