Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
NCT ID:
NCT00523068
Eligibility 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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
35 Years
Maximum Age:
70 Years
Study:
NCT00523068
Study Brief:
Protocol Section:
NCT00523068