Urinary Incontinence, Stress Clinical Trial
Official title:
Randomized Pilot Study on the Treatment of Mixed Urinary Incontinence: Pharmacological Treatment (Tolterodine SR) vs Surgery With Tension Free Vaginal Tape
In patients with symptoms of mixed incontinence (loss of urine associated with
coughing/sneezing/laughing, and loss of urine associated with the strong urge to void), is
surgical treatment with tension free vaginal tape or pharmacological treatment with
tolterodine more effective? What are the parameters predictive of success or failure with
either forms of treatment? What are the parameters predictive of the necessity for further
treatment after primary treatment?
Patients will be randomised to having surgical or pharmacological treatment for their mixed
incontinence symptoms. They will be assessed subjectively and objectively pre-treatment and
after treatment at intervals up to 3 months.
The aim of the study is to compare the efficacy and effect on the patient subsequent to
pharmacological treatment with single dose tolterodine compared to surgical treatment with
TVT in patients with urodynamically demonstrated mixed urinary incontinence, but with
prevailing symptoms of stress incontinence. Secondary aims are the identification of
parameters predictive of success or failure for the two treatments (echography, duration of
the symptoms) and the necessity for further treatment after the primary therapy. The primary
objective is to reduce the number of incontinence episodes after treatment with either
modality.
The design will be randomisation of 40 patients, with 20 in the surgical group and 20 in the
pharmacological treatment group. The patients must be female and aged between 35 and 70.
They should not be intending to fall pregnant and be capable of completing a questionnaire
about their incontinence symptoms and quality of life, a diary of their incontinence
episodes and account of the passing of their urine, as well as be able to give informed
consent to participate in the study.
The study will last for approximately 12 months and will consist of 5 visits. At the first
visit, the patient will be seen to verify their suitability for admission into the study,
have baseline blood tests, and urine analysis, as well as urodynamic assessment. They will
also be given a diary to fill out an account of their urine passing which they will be asked
to complete for the course of 3 days prior to their next appointment.
At the second appointment, the patient's diary will be collected and reviewed, a quality of
life questionnaire will be completed, as well as an ultrasound scan performed to assess the
thickness of the wall of their bladder. The patients will then be randomised into the
pharmacological and surgical groups. Those in the surgical group will be put onto the
waiting list for TVT (which they will have within 2 weeks of the second appointment), or
commence treatment with tolterodine.
4 weeks after either treatment the patients are seen again and their symptoms are assessed
and a second diary of the urinary behaviour (completed by the patient for the week prior to
this visit) will be reviewed.
On the final visit, which will be after 12 weeks of treatment, the patients undergo
urodynamic testing, diary assessment, symptom assessment, a quality of life questionnaire is
completed and an appraisal of the patient's satisfaction with their treatment is collected.
The discussion of need for any further treatment will take place and at this stage the
patient may then have their treatment changed to either the tolterodine or surgery depending
on their symptoms. These patients will then be finally seen after six months to review their
progress.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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