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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12608000624381 |
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Date of registration:
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09/12/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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MiniArc and Monarc suburethral sling in women with stress urinary incontinence - a randomised controlled trial
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Scientific title:
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In female patients with Stress Urinary Incontinence, is MiniArc as good as Monarc in objective cure rates? |
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Date of first enrolment:
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30/04/2009 |
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Target sample size:
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220 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://anzctr.org.au/ACTRN12608000624381.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Contacts
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Name:
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Ms Registered Nurse Elisabeth Thomas
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Address:
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Dept Urogynaecology Mercy Hospital for Women 163 Studley Road Heidelberg VIC 3084
Australia |
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Telephone:
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+613 84584862 |
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Email:
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ethomas@mercy.com.au |
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Affiliation:
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Name:
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Dr Dr Joseph Lee
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Address:
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Dept Urogynaecology Mercy Hospital for Women 163 Studley Road Heidelberg VIC 3084
Australia |
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Telephone:
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+613 84584862 |
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Email:
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joseph.lee@southernhealth.org.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: female patients with urodynamic stress incontinence
Exclusion criteria: evidence of instrinsic sphincter deficiency
previous failed suburethral tapes
untreated detrusor overactivity, unfit for surgery, history genital tract malignancy or fistula, previous radiation to pelvis, known allergy to polypropylene
Age minimum:
18 Years
Age maximum:
No limit
Gender:
Females
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Health Condition(s) or Problem(s) studied
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Female Stress Urinary Incontinence;
Female Stress Urinary Incontinence
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Surgery - Surgical techniques
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Intervention(s)
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Intervention treatment - MiniArc - Exitless transobturator placement of suburethral sling with fixation tip at obturator membrane. Intervention is - MiniArc placement of suburethral sling. Follow up is scheduled for 6 weeks, 6 months, 12 months, 24 months and 36 months.
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Primary Outcome(s)
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objective cure of stress urinary incontinence. Positive or negative clinical cough testing resulting in loss (positive) of urine during follow up clinical assessment[6 months from intervention or comparator treatment]
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Secondary Outcome(s)
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subjective patient reported outcome using validated questionnaire International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ UI SF) and Patient Global Impression of Improvement (PGI-I)[6 months from intervention or comparator treatment]
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subjective patient reported outcome using validated questionnaire International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ UI SF) and Patient Global Impression of Improvement (PGI-I)[12 months, 24 months and 36 months from treatment]
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Source(s) of Monetary Support
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American Medical System (AMS)
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Ethics review
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Status: Approved
Approval date:
Contact:
Mercy Health Human Research Ethics Committee
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Status: Approved
Approval date:
Contact:
Southern Health Human Ethics Research Committee B
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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