Over active bladder syndrome Urological and Genital Diseases Over active bladder syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults (female and male) suffering refractory OAB syndrome, 8 or more micturitions in 24 hours and questionnaire OAB-q SF score = 20 points 2. No response to medication 3. Evolution time = 6 months 4. Agree to participate and sign informed consent
Exclusion criteria
Exclusion criteria: 1. Urinary tract infection 2. History of congenital urogenital disease, radiation, bladder cancer or litiasis 3. People who can not participate because of religious, cultural or mental reasons 4. People who can not participate because of do not sign informed consent or unwilling to participate in the protocol 5. Pregnancy 6. Age less than 18 years old 7. History of taking OAB medication for less than 2 weeks before to start PTNS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bladder activity (nocturia, incontinence or urgency and frequency)is measured using the patient diaries for Group 1 and Placebo Group at baseline, 24 hours, one, three and six months and for Group 2 at baseline, one, three and six months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overactive bladder symptoms are measured using OABq-SF Questionnaire Part A for Group 1 and Placebo Group at baseline, 24 hours, one, three and six months and for Group 2 at baseline, one, three and six months. 2. Overactive bladder symptoms are measured using Perception of Bladder Condition (PPBC) Questionaire for Group 1 and Placebo Group at baseline, 24 hours, one, three and six months and for Group 2 at baseline, one, three and six months | — |
Countries
Mexico