neurogenic overactive bladder urinary incontinence
Conditions
Interventions
Patients who are, after screening, eligible for participation in the trial will
receive a lead implant at visit 3 to assess patient*s initial response to
pudendal neuromodulation. The position of th
Sponsors
Medtronic International Trading Sarl
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Eighteen years of age or older; • Incomplete upper motor neuron lesion due to trauma or disease of the spinal cord (1 year post-lesion); • Urodynamically proven overactive detrusor function; • Minimum of 2 leaks or 2 notices of leaks per day (demonstrated on a 5-day voiding diary); • Mean functional bladder capacity (volume voided per episode) of > 100mL; • Normal upper urinary tract function as assessed by ultrasound imaging; • Failed, intolerance or incomplete response to conservative pharmacotherapy; • Failed or insufficient improvement of symptoms with conservative non pharmacotherapy treatment.
Exclusion criteria
Exclusion criteria: • Complete spinal lesion or complete bilateral lesion of sacral/pudendal nerves; • Primary stress incontinence or mixed incontinence where stress component overrides the urge component; • Degenerative disease of the central nervous system; • Urinary tract mechanical obstruction such as benign prostatic hyperthropy, cancer or urethral stricture. • Symptomatic urinary tract infection • Morphological abnormalities of the bladder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean difference in functional bladder capacity, as measured by the average voiding volume per episode, between stimulation ON for 4 weeks and OFF for 4 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| The effect of pudendal neuromodulation (PNM) stimulation ON or OFF on: • Urgency urinary incontinence as measured by the average number of incontinence episodes per day. • The maximum voided volume per episode • Average number of voiding episodes per day • Average number of urgency episodes per day Assess therapy effects after 6 and 12 months of treatment: • On functional bladder capacity as assessed by the average voiding volume per episode • On urgency urinary urine incontinence measured by the average number of incontinence episodes per day. • On the maximum voided volume per episode. • On the average number of voiding episodes per day • On the average number of urgency episodes per day • On patient*s quality of life (Qualiveen) • On bladder capacity as measured by urodynamics • Collection of safety data Explorative outcome measures: • To assess the effect of therapy on patient*s general health using the EQ-5D questionnaire • To assess the effect of PNM on fecal constipation and fecal incontinence • To assess the effect of PNM on sexual function • To collect information on the direct medical resource use and cost impact of the therapy on patients. | — |
Countries
Netherlands
Outcome results
None listed