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Completed

NCT Number: NCT01730300

Genitourinary Symptoms With Levonorgestrel Releasing Intrauterine Systems

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.

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Key information

Age range

15 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Istanbul, 34250, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. Urinary frequency

    Time frame: 6 months

    We think that the urinary frequency will be lesser after 6 months of the therapy.

Secondary outcomes

  1. social activity

    Time frame: 6 months

    We think that social activity will be better after reducing urinary symptoms

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

Genitourinary Symptoms in Women Using Levonorgestrel Releasing Intrauterine Systems

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 21, 2012
Registry last updated
May 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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