overactive bladder.
Conditions
Interventions
Intervention 1: Intervention group: Intravaginal Dysport (Abobotulinum toxin A, Ipsen Biop- harmaceuticals, Pharma, Germany) injection: In this group, local anesthesia is applied on an outpatient basi
diluted lidocaine is injected in to the anterior wall of the vagina at the lithotomy position. The standard dose of Dysport (10 units per kilogram of patient's body weight ) is then diluted by injecta
Coloplast, Humlebaek, Denmark) through cystoscope, and Foley catheter is fixed at the end of the procedure.
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult women with overactive bladder who have not responded to initial medical treatment
Exclusion criteria
Exclusion criteria: Age under 18 years patients with neurogenic bladder (known cases of neurological defects) Active UTI Women with intact Hymen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ICIQ-OAB symptom score. Timepoint: Before and 4 weeks after intervention. Method of measurement: Validated questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain severity. Timepoint: Before and 4 weeks after intervention. Method of measurement: VAS score.;Incidence of gross hematuria. Timepoint: Within a week after the intervention. Method of measurement: View Foley catheter / Ask the patient.;Incidence of dysuria. Timepoint: Within a week after the intervention. Method of measurement: Ask the patient.;Incidence of UTI. Timepoint: Within a week after the intervention. Method of measurement: Urine culture.;Incidence of urinary retention and need for CIC. Timepoint: Within a week after the intervention. Method of measurement: Ultrasonography and ask the patient. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaede Mohseni
Hamedan University of Medical Sciences
Outcome results
None listed