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NCT01730300 Clinical Trial

Genitourinary Symptoms With Levonorgestrel Releasing Intrauterine Systems

Lower Urinary Tract Symptoms Clinical Trial

Official title:
Genitourinary Symptoms in Women Using Levonorgestrel Releasing Intrauterine Systems

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01730300
Other study ID # LN-IUSBDSK
Secondary ID
Status Completed
Phase N/A
First received November 15, 2012
Last updated May 14, 2013
Start date June 2012
Est. completion date May 2013

Study information
Verified date May 2013
Source Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Contact n/a
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date May 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Female
Age group 15 Years to 55 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Turkey Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Urinary frequency We think that the urinary frequency will be lesser after 6 months of the therapy. 6 months Yes
Secondary social activity We think that social activity will be better after reducing urinary symptoms 6 months Yes
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