Urodynamic Stress Incontinence Clinical Trial
Official title:
A Randomized Study of the Treatment of Urodynamic Stress Incontinence: the Tension Free Vaginal Tape (TVT) Versus the Miniarc Sling.
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 advantages to women with USI will be potentially significant since the
Miniarc may be carried out as an office based procedure, negating the need for an
anaesthetic and hospital admission. The investigators null hypothesis is that there is no
difference in subjective or objective outcome between the TVT and the Miniarc in the
treatment of USI.
Eligible women will be initially assessed with a full history and examination, King's Health
Questionnaire and twin channel subtraction cystometry. They will be randomised (using a
series of numbered opaque envelopes) to undergo either the TVT or Miniarc. Follow up will be
at 6 weeks, with a subjective outcome measure and at 6 months with a repeat subjective
assessment and repeat twin channel cystometry.
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 be decided after
consultation with a statistician.
All patients will be recruited from urogynaecology clinics at Medway Maritime Hospital. They
will be female and have a urodynamic diagnosis of stress incontinence, having failed
conservative management. Those deemed suitable for the TVT operation will be offered entry
to the study.
Randomisation and blinding
Patients who have consented to take part in the study will be randomised to have either a
conventional TVT (Group A) or a MiniArc (Group B). Each group will be run in parallel.
Method of randomisation - consecutively numbered opaque envelopes detailing type of
operation.
Patients will be blinded as to the type of tape used. Due to the obvious differences between
the devices, it will not be possible to blind researchers to the type of tape.
Each patient will undergo a pre-operative assessment (which may be incorporated into the
initial clinic visit), be admitted as an in-patient for the TVT/Mini-arc procedure, and
attend a post-operative assessment visit. This last visit will be the exit point from the
study. These are detailed below
Pre-operative Assessment
1. Detailed symptom history and examination
2. 3 day urinary diary
3. King's Quality of Life questionnaire
4. Dual channel normal saline subtracted cystometry at a filling rate of 50-100ml/min
whilst supine and standing. 7F double lumen catheter used for all measurements
Surgical Technique
Group A will have the TVT inserted under spinal anaesthesia as described by Ulmsten12. Group
B will have the MiniArc tape inserted under spinal anaesthesia. All procedures will be
undertaken in an operating theatre environment, and carried out by Mr Duckett or a member of
his team who has undergone appropriate training. Patients will be catheterised until 6 hours
post-operatively. Those who void with a residual of less than 100mls will be discharged the
day after the procedure.
Post-operative assessment
1. Carried out at 6 weeks' post-operatively
2. Symptoms assessed using 3 day urinary diary and Patient Global Impression of
Improvement (PGI-I)
3. King's quality of life questionnaire
4. Repeat urodynamic studies as described previously, including voiding cystometry (6
months only)
5. Any complications noted, e.g. readmission to hospital, UTI, voiding difficulties
6. Patient satisfaction will be assessed using a 5 point scale at the follow up visit
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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