Reducing radiation exposure during InterStim lead placement
Completed
- Conditions
- Nervous System DiseasesOveractive bladder, fecal incontinence
- Registration Number
- ISRCTN37385347
- Lead Sponsor
- Metro Health Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall surgery time is measured in seconds until the end of surgery
- Secondary Outcome Measures
Name Time Method 1. Number of skin punctures made during the surgical procedure<br>2. Quality of life is assessed using the following questionnaires at baseline, 4 weeks and 2 years:<br>2.1. The International Consultation on Incontinence Modular Questionnaire Overactive Bladder Symptoms Quality of Life (ICIQ-OABqol) for urinary symptoms<br>2.2. The Overactive Bladder Symptom Score (OABSS) for urinary symptoms<br>2.3. The Fecal Incontinence Quality of Life Scale (FIQL) for fecal incontinence