Transcript Sacral Neuromodulation in 52 Patients Suffering From Bladder

Sacral Neuromodulation in 52
Patients Suffering From
Bladder Disorders and/or
Pelvic Pain
G. Colini Baldeschi
G. Babbolin
Introduction
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.
FDA approved sacral neuromodulation
in 1997 as a treatment option for
Urge incontinence
Dysfunctional bladder
Urgency/frequency
syndromes
Non-obstructive
urinary retention
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 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.
Materials and Methods
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.
Upside down techinique
Sacral Hiatus approach
Stimulation Parameters
PW Range: 100-350 msec
FR Range: 40-60 Hz
Amp. Range: 0.4 – 4.0 mA
Results
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
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.
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.
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
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
Medical History
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.

Upside down
Technique (2002)
F = 50
PW = 150
AMP = 1.6
LEAD - - - +
---+
Cyclic
stimulation
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
SAMPLE
52 PATIENTS
SEX: 36F 16M
Urge urinary Incontinence
Urinary retention
Chronic pelvic pain
Interstitial cystitis
Neurogenic overactive bladder
22
20
8
1
Urge urinary
Incontinence
Urinary retention
1
Chronic pelvic
pain
Interstitial cystitis
Neurogenic
overactive
bladder
SAMPLE
47 PATIENTS
SEX: 32F 15M
Sample
Urge urinary incontinence
Urinary retention
Interstitial cystitis/PBS
Neurogenic overactive bladder
Chronic pelvic pain
MEAN AGE:
55 YRS (21-78)
20
18
MEAN PAIN
ONSET:
4YRS 8 MTHS
7
1
Urge urinary
incontinence
Urinary retention
1
Chronic pelvic pain
Interstitial
cystitis/PBS
Neurogenic overactive
bladder
NRS 1 month
Reduction 65%
8,2
2,9
NRS 24 Months
Reduction 56%
8,2
3.6
Time 0
24 months
SF-36
100
90
80
70
60
50
40
30
20
10
0
Before Treatment
After Treatment
Pain Medications
30
25
20
Same therapy
Reduction >50%
Stop pain medications
15
10
5
0
1 month
12 months
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.
These patients should not wait too long before we
find the right solution to their problem
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