Status:
COMPLETED
Tension Free Vaginal Tape (TVT) Versus the Miniarc Sling
Lead Sponsor:
Medway NHS Foundation Trust
Conditions:
Urodynamic Stress Incontinence
Eligibility:
FEMALE
Phase:
NA
Brief Summary
The aim of this study is to assess whether the Miniarc suburethral sling is equivalent to the TVT in the treatment of women with urodynamic stress incontinence (USI). If equivalence is proven, the adv...
Detailed Description
Description Randomised, prospective study. Objective and subjective outcomes to be evaluated 6 weeks an d6 months post-operatively. Study population The number of patients enrolled in the study will ...
Eligibility Criteria
Inclusion
- Patients must be female
- Subjective evidence of stress predominant symptoms on symptom specific questionnaire
- Stress incontinence on urodynamics
- Patients who are capable of understanding and signing the written consent form for participation in the study
- Patients must have completed their family
- Patients must be capable of filling in the symptom diary and micturition diary
Exclusion
- Patients who are medically unfit to undergo surgical intervention.
- Patients who have undergone previous continence surgery
- Prolapse beyond the introitus
- Patients with voiding dysfunction
- Patients with recurrent urinary tract infections
- Patients with haematuria of unknown origin or known bladder pathology
- Patients who are not sure that their family is complete
- Patients unwilling to use a safe method of contraception following the procedure
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00843908
Start Date
February 1 2008
End Date
August 1 2009
Last Update
August 27 2009
Active Locations (1)
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1
Medway Maritime Hospital
Gillingham, Kent, United Kingdom, ME7 5NY