Genitourinary Symptoms With Levonorgestrel Releasing Intrauterine Systems
Genitourinary Symptoms in Women Using Levonorgestrel Releasing Intrauterine Systems
1 other identifier
observational
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2012
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 15, 2012
CompletedFirst Posted
Study publicly available on registry
November 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedMay 15, 2013
May 1, 2013
7 months
November 15, 2012
May 14, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Urinary frequency
We think that the urinary frequency will be lesser after 6 months of the therapy.
6 months
Secondary Outcomes (1)
social activity
6 months
Eligibility Criteria
15-55 aged women using levonorgestrel releasing intrauterine device for the treatment of menorrhagia or adenomyosis
You may qualify if:
- women using levonorgestrel releasing intrauterine device for the treatment of menorrhagia or adenomyosis
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology
Istanbul, 34250, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 23916583DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Training Officer of Obstetrics and Gynecology Department M.D.
Study Record Dates
First Submitted
November 15, 2012
First Posted
November 21, 2012
Study Start
June 1, 2012
Primary Completion
January 1, 2013
Study Completion
May 1, 2013
Last Updated
May 15, 2013
Record last verified: 2013-05