Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 2 of 130 for:    Open Studies | "Urinary Incontinence"

Pharmacological vs Surgical Treatment for Mixed Incontinence

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Imperial College London.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00523068
First received: August 29, 2007
Last updated: November 6, 2007
Last verified: August 2007
  Purpose

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 Intervention Phase
Mixed Urinary Incontinence
Urinary Incontinence, Stress
Urinary Incontinence, Urge
Drug: Tolterodine
Procedure: tension free vaginal tape
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Pilot Study on the Treatment of Mixed Urinary Incontinence: Pharmacological Treatment (Tolterodine SR) vs Surgery With Tension Free Vaginal Tape

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • improvement in subjective and objective measures of urinary incontinence [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: September 2007
Estimated Study Completion Date: January 2010
Arms Assigned Interventions
Active Comparator: 1
Tension Free Vaginal Tape
Procedure: tension free vaginal tape
Active Comparator: 2
Tolterodine tartrate 4mg
Drug: Tolterodine
Other Name: detrusitol XL

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must be female as this is a urogynaecology study.
  2. An age of between 35 and 70 years. This takes into account that incontinence tends to prevail in women with advancing years. Younger women may be planning to start a family which precludes them from participating.
  3. Clinical urodynamic evidence of mixed incontinence with prevalence of symptoms of stress incontinence assessed by means of a specific questionnaire and visual analog scale (VAS). The study is assessing the treatment of mixed incontinence and the patients will have to have evidence of this which is provided by their symptoms.
  4. Candidates for corrective surgery of the component of sphincter defect with Ba < - 1 according to the International Continence Society (ICS) classification of genital prolapse.
  5. Patients capable of filling in the micturition diary, the VAS, and the pathology specific quality of life questionnaire, the Kings Health Questionnaire. These form part of the continuing assessment of effectiveness of treatment.
  6. Patients capable of understanding and signing an informed written consent form for participating in the trial. If patients are unable to give their consent for the procedures and investigations they cannot be ethically recruited.
  7. Patients who accept not to give birth vaginally in the future, so as not to jeopardize the results of the surgical operation.

Exclusion Criteria:

  1. Contraindications for using anti-cholinergic agents (urinary retention, uncontrolled narrow-angle glaucoma, myasthenia gravis, severe ulcerative colitis, toxic megacolon). Anticholinergics form one group of the patients and inability to take these drugs therefore precludes them from participating.
  2. Ascertained hypersensitivity to tolterodine or any of the excipients. For the above reason.
  3. Presence of pathologies or conditions that in the Investigator's opinion make the patient unsuitable for inclusion.
  4. Patients with urinary tract infections (UTI) during the run-in period.
  5. Patients with recurrent urinary tract infections (> 5 in the past 12 months).
  6. Patients with diagnosed interstitial cystitis.

    These compromise the results obtained.

  7. Patients with haematuria of uncertain origin. These patients need urgent investigation of these signs with procedures that are not included in the study.
  8. Patients on treatment with anti-cholinergic agents of other drugs acting on detrusor instability. This will compromise the results of the study if for example these patients are randomised into the surgical group.
  9. Patients on treatment with oestrogens, unless the therapy was commenced at least 2 months prior to inclusion in the study and follows a constant dosage.
  10. Patients on diuretics. This affect their urinary behaviour.
  11. Patients on concomitant treatment with potent CYP 34A inhibitors, such as macrolide antibiotics or antimycotic agents.
  12. Patients who have undergone previous surgery on the distal urinary tract (with the exception of hysterectomy).
  13. Patients who do not have adequate contraceptive cover or patients who are breast-feeding. For reasons of avoiding pregnancy during the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523068

Contacts
Contact: Demetri C Panayi, BSc MRCOG 02078861016 d.panayi@imperial.ac.uk

Locations
United Kingdom
Demetri C Panayi Not yet recruiting
London, United Kingdom, sw18 4qr
Contact: Demetri C Panayi, BSc MRCOG    02078861016    d.panayi@imperial.ac.uk   
Sponsors and Collaborators
Imperial College London
Investigators
Study Director: Vikram Khullar Imperial College London
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00523068     History of Changes
Other Study ID Numbers: 07/s0501/26
Study First Received: August 29, 2007
Last Updated: November 6, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Imperial College London:
overactive bladder
stress urinary incontinence
detrusor overactivity
urodynamics

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urinary Incontinence, Urge
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations
Tolterodine
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on November 20, 2014