Assessment of Patient-reported Goal Attainment in the Treatment of Female Overactive Bladder

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

For many years, antimuscarinics have been first-line pharmacological treatment for OAB. A recent meta-analysis of randomised, controlled trials on antimuscarinic treatment of OAB concluded that the drugs provide significant improvements in OAB symptoms compared with placebo but that the benefits are of limited clinical significance. The analysis questioned the clinical significance of the trial results, one reason for which was the lack of data on the use of sensitive patient-driven criteria. Traditional symptomatic and urodynamic measures of treatment success may be meaningful to clinicians but often have little meaning to patients. Therefore, patient-reported outcomes (PROs), which provide a subjective measure of a patient's response to treatment, are useful. Recently, clinicians treating OAB have begun to recognize the value of PROs but still overlook the treatment efficacy in terms of patient-reported goal achievement (PGA).

Patients with OAB have combination of symptoms and the extent to which individual OAB symptoms affect patients varies. Also each patient can have different goal for the treatment. Therefore, assessing the degree of goal achievement in each patient can provide a new aspect of treatment benefit.

This controlled study will advance the understanding of OAB in terms of patient-centered treatments goals and goal achievement and will provide a new aspect of treatment benefit.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Collaborator: Pfizer
• Treatments: Tolterodine Tartrate

Criteria

Inclusion Criteria:

1. Female aged ≥ 18 and ≤ 80 years

2. Symptoms of OAB as verified by the screening 3 day micturition diary, defined by:

Mean urinary frequency ≥8 times/24 hours Mean number of urgency episodes ≥ 2 episode/24 hours

3. Symptoms of OAB for ≥ 3 months.

4. Ability and willingness to correctly complete the micturition diary and questionnaire

5. Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits

Exclusion Criteria:

1. Subjects with stress incontinence or mixed stress/urge incontinence where stress incontinence is the predominant component based on prior history.

2. Significant hepatic or renal disease, defined as having twice the upper limit of the reference range for serum concentrations of aspartate amino- transferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]), alkaline phosphatase or creatinine.

3. Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention

4. Symptomatic acute urinary tract infection (UTI) during the run-in period

5. Recurrent UTI defined as having been treated for symptomatic UTI > 4 times in the last year

6. Diagnosed or suspected interstitial cystitis

7. Clinically significant bladder outlet obstruction or poor detrusor function defined by clinical symptoms and investigator's opinion according to local standard of care

8. Previous history of major urethral and/or bladder surgery

9. History of radiation treatment (external or interstitial) to pelvic organs or external genitalia for any reason.

10. Subjects with neuropathology that could affect the lower urinary tract or nerve supply

11. Patients with marked cystocele or other clinically significant pelvic prolapse.

12. Subjects with current (within 2 years) urogenital neoplasms or malignancies including bladder, uterine or cervical cancer

13. Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with: Any anticholinergic drugs other than trial drug Any drug treatment for overactive bladder

14. On an unstable dosage of any drug with anticholinergic side effects, or expected to start such treatment during the study

15. Subjects currently taking tricyclic antidepressants, diuretics or alpha blockers who have not been on a stable dose of these medications for at least one month

16. Current administration of a selective serotonin reuptake inhibitor (SSRI) and has not been on a stable dose for at least three months

17. Receipt of any electrostimulation or bladder training within the 14 days before randomization, or expected to start such treatment during the study

18. An indwelling catheter or practicing intermittent self-catheterization

19. Use of any investigational drug within 1 months preceding the start of the study

20. Patients with chronic constipation or history of severe constipation

21. Pregnant or nursing women

22. Sexually active females of childbearing potential not using reliable contraception for at least 1 month prior to study start and not agreeing to use such methods during the entire study period and for at least 1 month thereafter *Reliable contraceptive methods are defined as intrauterine devices (IUDs), combination type contraceptive pills, hormonal implants, double barrier method, injectable contraceptives and surgical procedures (tubal ligation or vasectomy).

23. Any other condition which makes the patient unsuitable for inclusion.