Overactive bladder, fecal incontinence Nervous System Diseases Overactive bladder, fecal incontinence
Conditions
Interventions
Eligible participants are randomly assigned into either the fluoroscopy or ultrasound group. Randomization is performed using a computer generated randomization number which assigns each patient to ei
Sponsors
Metro Health Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of overactive bladder, non-obstructive urinary retention, or fecal incontinence 2. Aged 18 years or older 3. Failure of previous conservative measures (i.e. behavior modification, biofeedback, pelvic floor training, at least one antimuscarinic or beta-agonist medication) 4. Medically fit to undergo proposed surgery 5. Patient able to consent
Exclusion criteria
Exclusion criteria: 1. Pregnant or planning on becoming pregnant 2. Severe or uncontrolled diabetes with peripheral nerve involvement 3. Knowledge of planned MRI or other procedures precluding implantation of device or need for removal 4. Severe BPH, prostate cancer, urethral stricture, or other mechanical obstruction 5. Active urinary tract, skin, or soft tissue infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall surgery time is measured in seconds until the end of surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of skin punctures made during the surgical procedure 2. Quality of life is assessed using the following questionnaires at baseline, 4 weeks and 2 years: 2.1. The International Consultation on Incontinence Modular Questionnaire Overactive Bladder Symptoms Quality of Life (ICIQ-OABqol) for urinary symptoms 2.2. The Overactive Bladder Symptom Score (OABSS) for urinary symptoms 2.3. The Fecal Incontinence Quality of Life Scale (FIQL) for fecal incontinence | — |
Countries
United States of America
Outcome results
None listed