Permanent Occlusion of Uteine Arteies in Management of Abnormal Uterine Bleeding

Study Overview
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Brief Summary
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Prospective observational interventional study , The study done in two phases: Phase one from October 2011to May 2012 pilot study including twenty nine (29) premenopausal patients followed up for six months Phase two from October 2012 till May 2014. Including Eighty nine (89) premenopausal patients all of them needing to preserve their uteri.

Detailed Description
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Abstract Objectives: To assess the effectiveness of permanent bilateral occlusion of uterine arteries in treatment of abnormal uterine bleeding. Design: prospective observational study Setting: Done in Mansoura university hospital, department of Obstetrics and gynecology. Patients and Methods: The study done in two phases: Phase one from October 2011to May 2012 pilot study including twenty nine (29) premenopausal patients followed up for six months Phase two from October 2012 till May 2014. Including Eighty nine (89) premenopausal patients all of them needing to preserve their uteri. Results: Results are hopeful and courageous in phase one as regards patients satisfaction, Quality of life and improvements of bleeding. Results of phase two will be implemented, analyzed and presented in tables. All data will be statistically analyzed and the results will be presented after completion of eighteen (18) months follow up to rule out any bias and/ or errors in the results. Conclusion: permanent bilateral uterine arteries occlusion may be a good alternative to radical surgery in abnormal uterine bleeding.

Official Title
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Interventional Gynecologic Surgery

Conditions
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Other Abnormal Uterine and Vaginal Bleeding

Intervention / Treatment
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* Procedure: bilateral permanent occlusion of uterine arteries


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: premenopausal with abnormal uterine bleeding and completed their families having normal endometrium (biopsy in preceding 6 months ) and may have uterine intramural myomas not exceeding 150 ml in volume and away from uterine cavity by at least 1cm and /or adenomyosis Exclusion Criteria: patients wishing future fertility endometrial sampling not done or more than 6 months or myoma encroaching or distorting cavity or larger than 150 ml in volume

Ages Eligible for Study
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Minimum Age: 34 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: BUAO<br>The study done in two phases: Phase one from October 2011to May 2012 pilot study including twenty nine (29) premenopausal patients followed up for six months Phase two from October 2012 till May 2014. Including Eighty nine (89) premenopausal patients | Procedure: bilateral permanent occlusion of uterine arteries<br>* bilateral permanent Occlusion of uterine arteries through abdominal route<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| uterine bleeding |  | October 2011 till January 2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction |  | october 2011 - may 2015 | 
| quality of life |  | october 2011 - may 2015 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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permenant occlusion, uterine bleeding, uterine arteries