Urinary Frequency/Urge, Urge incontinence and Non obstructive Urinary Retention.
Conditions
Interventions
Current trial information
In this study patients with sacral neuromodulation therapy are included. We will start with changing the pulse rate to 3 other different Hz (5.2 - 25- 40) and once to the us
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: Current trial information 1. Patients who signed the informed consent. 2. Patients (male and female), aged between 18-80 years, with SNM therapy for complaints of urge incontinence or urgency frequency. 3. Patients (male and female), aged between 18-80 years, with SNM therapy for complaints of urinary retention or voiding dysfunction, such as hesitancy or intermittence, that are due to an hypocontractile detrusor or obstruction due to urethral sphincter overactivity. 4. A suboptimal result with the treatment. For patients with incontinence this means that they are not completely dry. For patients with retention this means that they still have to use a catheter to void. History at time of registration 1. Patients (male and female), aged between 18-60 years, with urge incontinence or urgency frequency, with overactive detrusor contractions on cystometry, who have been successfully tested for treatment with SNS. Successful treatment will be defined as > 50% improvement in the relevant voiding symptoms and will be measured by comparison of a voiding diary during the test before implant with the voiding diary before implant; 2. Patients (male and female), aged between 18-60 years, with urinary retention or voiding dysfunction, such as hesitancy or intermittence, that are due to an hypocontractile detrusor or obstruction due to urethral sphincter overactivity, demonstrated on cystometry , who have been successfully tested for treatment with SNS. Successful treatment will be defined as > 50% improvement in the relevant voiding symptoms and will be measured by comparison of a voiding diary during the test before implant with the voiding diary before implant.
Exclusion criteria
Exclusion criteria: Current trial information 1. People who have SNM therapy for other reasons which is not mentioned in the such as abdominal pain. 2. People of which their battery needs to be replaced by a new one, due to low battery life. History at time of registration Conditions which preclude patient suitability for SNS therapy: 1. Patients with current psychiatric disorders; 2. Current or plans of pregnancy; 3. Neurologic voiding disorders; including DM (severe or uncontrolled diabetes; or diabetes with peripheral nerve involvement), spinal cord injury, MS; 4. Reiter’s syndrome; 5. Concomitant medical conditions that would limit the success of the procedure such as: active degenerative disc disease, spinal cord injury< 6 months old, bleeding complications, CVA< 6 months old etc; 6. Extraurethral incontinence; 7. Pelvic pain of uncertain etiology that is not associated with a voiding dysfunction or where pelvic pain is the primary complaint/ diagnosis; 8. Anatomic obstructive voiding disorders; 9. Current urinary tract infection; 10. Malignancy of urinary tract; 11. Severe grade III/IV pelvic prolapse, cystocele, urethrocele, enterocele; 12. Proven interstitial cystitis or clinical symptoms of interstitial cystitis; 13. Clinical significant stress incontinence; 14. (Evident functional neurologic asymmetry).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Improvement in voiding diaries results between the ‘standard’ frequency (10 Hz) and pulsewidth (210µs) and new settings. Improvement is measured by computer assisted comparison of voiding diaries taken with the ‘standard’ settings and with the new settings and is reflected in percentage improvement achieved. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient toleration of rate changes; 2. Difference between optimal settings between patients with either urge symptoms or retention symptoms. | — |
Contacts
Public ContactR. Leong
Postbus 5800
Outcome results
None listed