This study will be a non-randomised, non-placebo controlled prospective clinical trial.
We intend to recruit approximately 100 patients that will receive and fill out the questionnaire before and after medical treatment with detrusitol 4mg.
Study protocol will receive approval of the local ethical committee.
Twenty general practitioners (GP) will actively participate in the recruitment and treatment of these patients. After a brief inquiry, patients with urinary complaints will be offered the option of completing the OAB-V8 questionnaire and to participate in this trial if eligible.
After the patient fills out the OAB-V8 and is found fit for this study, the patient will receive accurate information regarding the study and will sign an informed consent form.
The study will consist of 2 visits, visit 1 pre and visit 2 post-treatment with Detrusitol 4mg.
Randomly selected patients will be requested to complete the OAB -V8 questionnaire. Those with a score >8 points will be eligible for inclusion. They will complete an informed consent form and will undergo a basic medical history. Patients will then be given treatment with detrusitol 4mg once daily (a total of 28 tablets). They will also be required to fill out a voiding/frequency and urgency chart for three days prior to commencing treatment and again three days before finishing the treatment period (day 25 of the treatment period) to confirm diagnosis of OAB. Patients will also be asked questions and lab work will be performed to rule out patients with other Urinary Conditions.
Information on side effects and a contact number 24/7 for any question or problem that arises will be provided. After the end of one-month treatment, patients will return for their 2nd and final visit.
Twenty-eight tablets of Detrusitol 4mg will be provided to every patient. Visit II: Patients will be evaluated with regard to effect of treatment by completing the OAB-V8 questionnaire again. On this visit, according to the physicians' professional consideration, satisfied patients will receive a prescription of Detrusitol 4mg for continuing treatment.
The statistical methods that will be employed will include Chi Square and Fisher exact tests, and logistic regression (the logistic will be run mainly for covariates such as age, gender and baseline symptom severity score to predict who achieve a 10 point change in symptom bother scale. Software utilised will include SAS and JMP.