Dorsal genital nerve sub-chronic stimulation implant in patients with overactive bladder syndrome

Symptoms of overactive bladder syndrome with or without detrusor overactivity
decrease quality of life. Not all patients respond satisfactorily to
conservative therapies. Patient-controlled electrical stimulation of the dorsal
genital nerve could be an alternative.

To determine the clinical value of chronic implantation of an electrode
adjacent to the dorsal genital nerve for conditional electrical stimulation in
patients with overactive bladder syndrome The aim is to have >60-70% decrease
in number of urgency incontinence episodes per 24 h.

Pilot study.

Patients will complete voiding diaries for 3 days prior to the date of
investigation. Patients will also complete an Urgency Severity Score sheet. An
electrode lead (PNE set 3065USC) connected to Medtronic test stimulator 3625
will be implanted under local anaesthesia adjacent to the dorsal genital nerve,
Patients will be able to activate the stimulator on conditional basis. Implants
will be explanted after 7 days. Patients will complete voiding diaries during
the stimulation period and for 3 days after explanation.

At the first visit, information about the study and intervention will be given.
The study intervention, with electrical stimulation, will be done at the second
visit. The third visit is to explant the electrode. The patients don*t have any
direct benefit, besides a reimbursement of travelling expenses and a gift
coupon (¤50,-). The risk of the adverse events is thought to be minimal,
because no vital organs are in the area of needle insertion. Possible risks are
temporary pain due to needle insertion, pain due to hitting the pubic bone
during electrode insertion and/or infection at the site of stimulation and
puncture, and vascular or nerve damage by electrode insertion.