1. Sacral Neuromodulation in 52 Patients Suffering From Bladder Disorders and/or Pelvic Pain G. Babbolin G. Colini Baldeschi

2. The aim of this study is to evaluate the efficiency of sacral neuromodulation using quadri/octopolar leads placed bilaterally in the epidural sacral space in patients suffering from bladder disorders and/or chronic pelvic pain. We performed a retrospective review of patients implanted from 2001-2012. Introduction

3. Dysfunctional bladder syndromes Urge incontinence Urgency/frequency Non-obstructive urinary retention FDA approved sacral neuromodulation in 1997 as a treatment option for

4. Chronic Pelvic Pain (Sacral neuromodulation Off-label) Definition (by Royal College of OB and GYN) Intermittent, or constant pain in lower abdomen or pelvis Not occurring exclusively with menstruation, intercourse or associated with pregnancy Duration > 6 months Localized to: anatomic pelvis, anterior abdominal wall, lumbosacral back or buttocks Sufficient severity to cause functional disability or lead to medical care American College of Obstetricians and Gynecologists Practice Bulletin No. 51, March 2004

5. Materials and Methods 52 patients with a history of bladder disorders and/or pelvic pain have been studied. Ages ranged from 21 to 78 years, with 36 female and 16 male patients. Five of these patients had previously undergone S3 root stimulation with the placement of a percutaneous lead with poor improvement of symptoms Patients have been assessed before surgery and before the final implant using SF-36 questionnaire and NRS. Patients were evaluated twice a year in subsequent years. The patients' follow up varies from 6 months to 11 years.

6.  Patients suffering from bladder disorders have been subjected to urodynamic examination before and after the trial period  Patients underwent the placement of two quadri/octopolar leads bilaterally on the sacral roots, under light sedation and local anesthesia.  The procedure was performed with patients in a prone position under fluoroscopic guidance.  After a successful trial period each patient underwent placement of a permanent system. Materials and Methods

7. Upside down techinique

8. Sacral Hiatus approach

9. Stimulation Parameters PW Range: 100-350 msec FR Range: 40-60 Hz Amp. Range: 0.4 – 4.0 mA

10.  Five patients did not have an adequate improvement during the trial, and the percutaneous leads were removed.  47 patients reported significant improvement after the trial period and were submitted to permanent implant  In four patients we have had the migration of one or two leads and the repositioning was necessary  We had no cases of infection, or postoperative pain.  The five patients previously implanted with S3 leads with no result, reported good functional recovery of the bladder after the trial period Results

11.  Pain reduction according to the NRS ranged from 65% to 56% at two years  In all patients with bladder disorders the urodynamic test performed after the procedure showed a significant functional improvement  All patients had significant improvement in all items of the SF-36.  64% of patients stopped taking pain medications and 36% of patients reduced the dosage of pain medications more than 50% after 12 months. Results

12. Female Patient, Aged 21 Chronic urinary retention secondary to caesarean section After surgery (1998) she manifested urinary retention The bladder disorder became chronic and a permanent catheter for 8 months was needed. During this time several uroseptic episodes After the removal of the permanent catheter autocatheterism was carried out about 6 times a day. Transforaminal S3 root stimulation (2000) without improvement For such a reason an external bladder derivation was suggested but not accepted by the patient.

13. Two quadripolar leads using the upside down technique (2001) F = 60 PW = 100 AMP = 1.7 r. 0.7 l. LEAD - - - + - - - + Intraoperatively the patient reported that she can “perceive her bladder”. Spontaneous micturition after two hours from surgery interrupted once the IPG was off or when one of the two leads have been switched off

14. Urodynamic test (before)  Non-contractile detrusorial muscle  Severe impairment of the proprioceptive sensitivity. Urodynamic test (after)  Bladder within range of normality  The bladder void was completed without involving the abdominal muscles

15. Male Patient Aged 43 Paraplegic patient with neurogenic overactive bladder secondary to vertebral metastases from lymphoma.

16. Medical History  In 1999 the patient underwent D6, D7, D8 decompressive laminectomy due to non Hodgkin lymphoma with paraplegia and neurogenic overactive bladder.  In September 2000: vertebral titanium prothesis for the fracture of the D7 body  Urinary catheter, frequent infections and catheter removal. Then a condom was positioned against continuous urine flow

17.  Urodynamic test: detrusor muscle hyperreflexia (max. 70 cm water) at filling volumes of 40 to 50 ml with urine flow in absence of minctional stimulous.  The patient underwent sacral neuromodulation in order to decrease the detrusorial hyperreflexia and the spasticity of the rectal ampulla. Medical History

18. F = 50 PW = 150 AMP = 1.6 LEAD - - - + - - - + Cyclic stimulation Upside down Technique (2002) The intraoperative stimulations gave no references but a sense of weight at anus

19. AFTER IMPLANT The urodynamic test was unchanged when the IPG was turned off Under stimulation we had an inhibition of the detrusor hyperactivity with an increase of the maximum bladder capacity up to 500 ml in relation to the parameters of stimulation Once the IPG was turned off the bladder became again overactive, and the bladder empties. The residual volume was eliminated with the Crede’s maneuver This allowed the patient to not wear a condom and limiting skin lesions, with a significant improvement in quality of life

20. SAMPLE 52 PATIENTS SEX: 36F 16M

21. SAMPLE 47 PATIENTS SEX: 32F 15M MEAN AGE: 55 YRS (21-78) MEAN PAIN ONSET: 4YRS 8 MTHS

22. NRS 1 month Reduction 65%

24. SF-36

26. Conclusion This type of sacral neuromodulation, appears to be effective in the treatment of bladder disorders and chronic pelvic pain. This treatment method is a good alternative to the transforaminal technique commonly used, and that should be taken into consideration when the transforaminal approach has not been effective.

27. “Hello, incontinence helpline – Can you hold?” These patients should not wait too long before we find the right solution to their problem