Genitourinary Symptoms With Levonorgestrel Releasing Intrauterine Systems

NCT ID: NCT01730300

Last Updated: 2013-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lower Urinary Tract Symptoms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* none
Minimum Eligible Age

15 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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murat ekin

Training Officer of Obstetrics and Gynecology Department M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Murat Ekin, M.D.

Role: STUDY_CHAIR

Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology

Cihan Kaya, M.D.

Role: PRINCIPAL_INVESTIGATOR

Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology

Mehmet E Ayag, M.D.

Role: PRINCIPAL_INVESTIGATOR

Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology

Locations

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Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Ekin M, Cengiz H, Ayag ME, Kaya C, Yasar L, Savan K. Effects of the levonorgestrel-releasing intrauterine system on urinary symptoms in patients with adenomyosis. Eur J Obstet Gynecol Reprod Biol. 2013 Oct;170(2):517-20. doi: 10.1016/j.ejogrb.2013.07.019. Epub 2013 Aug 3.

Reference Type DERIVED
PMID: 23916583 (View on PubMed)

Other Identifiers

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LN-IUSBDSK

Identifier Type: -

Identifier Source: org_study_id

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