Sacral Neuromodulation in 52 Patients Suffering From

Bladder Disorders and/or Pelvic Pain

G. Babbolin

G. Colini Baldeschi

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

Dysfunctional bladder

syndromes

Urge incontinence

Urgency/frequency

Non-obstructive urinary retention

FDA approved sacral neuromodulation in 1997 as a treatment option for

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

Materials and Methods52 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.

Patients suffering from bladder disorders have been subjected to urodynamic examination before and after the trial periodPatients 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

Upside down techinique

Sacral Hiatus approach

Stimulation Parameters

PW Range: 100-350 msecFR Range: 40-60 HzAmp. Range: 0.4 – 4.0 mA

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 implantIn four patients we have had the migration of one or two leads and the repositioning was necessaryWe 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

Pain reduction according to the NRS ranged from 65% to 56% at two yearsIn all patients with bladder disorders the urodynamic test performed after the procedure showed a significant functional improvementAll 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

Female Patient, Aged 21Chronic urinary retention secondary

to caesarean section

After surgery (1998) she manifested urinary retentionThe 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.

Two quadripolar leadsusing the upside down technique (2001)

F = 60PW = 100AMP = 1.7 r. 0.7 l.LEAD - - - + - - - +

Intraoperatively the patient reported that shecan “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

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

Male Patient Aged 43

Paraplegic patient with neurogenic overactive bladder

secondary to vertebral metastases from lymphoma.

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

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

F = 50 PW = 150AMP = 1.6 LEAD - - - + - - - + Cyclic stimulation

Upside downTechnique (2002)

The intraoperative stimulations gave no references but a sense of weight at anus

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

SAMPLE52 PATIENTS SEX: 36F 16M

SAMPLE47 PATIENTS SEX: 32F 15M

MEAN AGE: 55 YRS (21-78)

MEAN PAIN ONSET: 4YRS 8 MTHS

NRS 1 monthReduction 65%

SF-36

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.

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