Pharmacological vs Surgical Treatment for Mixed Incontinence
|ClinicalTrials.gov Identifier: NCT00523068|
Recruitment Status : Unknown
Verified August 2007 by Imperial College London.
Recruitment status was: Not yet recruiting
First Posted : August 30, 2007
Last Update Posted : November 7, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Mixed Urinary Incontinence Urinary Incontinence, Stress Urinary Incontinence, Urge||Drug: Tolterodine Procedure: tension free vaginal tape||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Pilot Study on the Treatment of Mixed Urinary Incontinence: Pharmacological Treatment (Tolterodine SR) vs Surgery With Tension Free Vaginal Tape|
|Study Start Date :||September 2007|
|Estimated Study Completion Date :||January 2010|
Active Comparator: 1
Tension Free Vaginal Tape
|Procedure: tension free vaginal tape|
Active Comparator: 2
Tolterodine tartrate 4mg
Other Name: detrusitol XL
- improvement in subjective and objective measures of urinary incontinence [ Time Frame: 3 months ]
- assessment of pre-treatment predictors of success or failure of treatment [ Time Frame: 3 months ]
- assessment of pre-treatment predictors of requirement for alternative treatment [ Time Frame: 3 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00523068
|Contact: Demetri C Panayi, BSc MRCOGemail@example.com|
|Demetri C Panayi||Not yet recruiting|
|London, United Kingdom, sw18 4qr|
|Contact: Demetri C Panayi, BSc MRCOG 02078861016 firstname.lastname@example.org|
|Study Director:||Vikram Khullar||Imperial College London|