difficulty in the enrolment

The study is designed to demonstrate that treatment with low level stimulation of the bladder muscles reduces symptoms of urinary incontinence in comparison with no stimulation.

The Medtronic InterStim device delivers stimulation therapy for the treatment of chronic intractable (functional) disorders of the pelvis and lower urinary or intestinal tract through the sacral nerve or the pudendal nerve systems.

This trial is designed to demonstrate that neuromodulation of the pudendal nerve will effectively treat patients with neurogenic overactive bladder. Symptoms of urinary incontinence are compared when stimulation is switched on for 4 weeks to stimulation switched off for 4 weeks. After the eight week crossover period, all patients receive treatment and are followed up within the study for 12 months post implant.

Inclusion Criteria:

• Incomplete upper motor neuron lesion
• Detrusor overactivity
• Two leaks or two notices of leaks per day
• Mean functional bladder capacity (volume voided per episode) of ≥100 ml

Exclusion Criteria:

• Complete spinal lesion or complete bilateral lesion of sacral / pudendal nerves.
• Degenerative disease of the central nervous system

The analysis was based on all randomized patients in the study. Due to early termination of the study, only 17 patients have been enrolled versus 78 planned enrolled patients. No analysis was done comparing the functional bladder capacity between the two intervention groups due to the low patient numbers in each group.

Adverse event reporting started at enrollment until study completion and/or study exit, an average of 14 months, whatever applies.