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Genitourinary Symptoms With Levonorgestrel Releasing Intrauterine Systems

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
murat ekin, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier:
NCT01730300
First received: November 15, 2012
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  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:

U.S. FDA Resources

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

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


Secondary Outcome Measures:
  • social activity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   15 Years to 55 Years
Genders 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:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 15, 2012
Last Updated: May 14, 2013
Health Authority: Turkey: Ministry of Health

Additional relevant MeSH terms:
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on May 16, 2013