| Surgery Section - Posterior Tibial Nerve Stimulation
for Voiding Dysfunction
| Topic: Posterior Tibial Nerve
Stimulation for Voiding Dysfunction |
Date of Origin: 08/08/06 |
| Section: Surgery |
Policy No: 154 |
| Approved Date: 03/10/2009 |
Effective Date: 03/10/2009 |
| Next Review Date: 10/2009 |
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IMPORTANT REMINDER
This Medical Policy has been developed through consideration of medical necessity,
generally accepted standards of medical practice, and review of medical literature
and government approval status.
Benefit determinations should be based in all cases on
the applicable contract language. To the extent there are any conflicts
between these guidelines and the contract language, the contract language will
control.
The purpose of medical policy is to provide a guide to coverage. Medical Policy
is not intended to dictate to providers how to practice medicine. Providers
are expected to exercise their medical judgment in providing the most appropriate
care.
Description
Posterior tibial nerve stimulation (PTNS) is a technique of electrical
neuromodulation for the treatment of voiding dysfunction in patients
who have failed behavioral and/or pharmacologic therapies. Voiding dysfunction
includes urinary frequency, urgency, incontinence, and nonobstructive
retention. Common causes of voiding dysfunction are pelvic floor dysfunction
(from pregnancy, childbirth, surgery, etc.), inflammation, medication
(e.g., diuretics and anticholinergics), obesity, psychogenic factors
and disease (e.g., multiple sclerosis, spinal cord injury, detrusor hyperreflexia,
diabetes with peripheral nerve involvement, etc.). Altering the function
of the posterior tibial nerve with PTNS is believed to improve voiding
function and control. While the posterior tibial nerve is located near
the ankle, it is derived from the lumbar-sacral nerves (L4-S3) which
control the bladder detrusor and perineal floor.
The procedure for PTNS consists of the insertion of a needle above the
medial malleolus into the posterior tibial nerve followed by the application
of low voltage (10mA, 1-10 Hz frequency) electrical stimulation which
produces sensory and motor responses (i.e., a tickling sensation and
plantar flexion or fanning of all toes). Noninvasive PTNS has also been
delivered with surface electrodes. PTNS studies have been designed as
30-minute sessions given weekly for 10-12 weeks. Recently, consideration
has been given to increasing the frequency of treatments to 3 times per
week to speed achievement of desired outcomes. However, an optimal treatment
approach has not been identified and the durability of PTNS is uncertain.
PTNS must be distinguished from acupuncture with electrical
stimulation. In
electrical acupuncture, needles are also inserted just below the skin, but the
placement of needles is based on specific theories regarding energy flow throughout
the human body. Thus in PTNS, the location of stimulation is directly in the
posterior tibial nerve rather than using the theories of energy flow that guide
placement of stimulation for acupuncture.
In July 2005, the Urgent® PC Neuromodulation System (Uroplasty,
Inc.) received 510(k) marketing clearance for percutaneous tibial nerve
stimulation to treat patients suffering from urinary urgency, urinary
frequency, and urge incontinence. This device was cleared as a class
II ‘‘nonimplanted, peripheral
nerve stimulator for pelvic floor dysfunction” because it was considered
to be substantially equivalent to the previously cleared percutaneous Stoller
afferent nerve system (PerQ SANS System) in 2001 (K992069, UroSurge, Inc.).
PTNS was developed as a less-invasive treatment alternative
to traditional sacral root neuromodulation which
has been successfully used in the treatment of urinary dysfunction, but
requires implantation of a permanent device. In sacral root neuromodulation,
an implantable pulse generator that delivers controlled electrical impulses
is attached to wire leads that connect to the sacral nerves, most commonly
the S3 nerve root that modulates the neural pathways controlling bladder
function. Note: Stimulation
of the sacral nerve as a treatment of incontinence is discussed separately in
policy No. Surgery 134. Pelvic floor stimulation as a treatment of urinary incontinence
refers to electrical stimulation of the pudendal nerve and is addressed separately
in policy No. Allied Health 4.
Policy/Criteria
Posterior tibial nerve stimulation for urinary dysfunction, including
but not limited to urinary frequency, urgency, incontinence and retention,
is considered investigational.
Position Summary
Study selection criteria used in the 1996 TEC Assessment
on percutaneous electrical nerve stimulation (PENS)
can be applied for the evaluation of evidence on posterior
tibial nerve stimulation (PTNS):
- The study contained original empirical data
- The
study design included a treatment group and a control
group
- The study reported on a health outcome relevant
to the condition treated
- The study used a random
assignment, control group design
Several clinical studies have reported on the use
of PTNS with some favorable outcomes, including reductions
in urinary frequency and urgency. However, no randomized,
controlled trials have been published comparing PTNS
to placebo or other voiding dysfunction treatments.
In a prospective observational study, Nuhoglu et
al treated 35 patients with overactive bladder with
10 weekly 30-minute sessions using the UroSurge device.
(2) Nineteen patients (54%) experienced significant
reductions in urinary urgency and increases in urine
volume after therapy. However, these effects were
maintained in only 8 patients (23%) after one year.
In a small study of 11 patients, van der Pal and
colleagues also found limited durability of PTNS
treatment effects as increases in incontinence and/or
voiding frequency occurred in 50% or more patients
6 weeks after treatment. (3) When treatment was resumed,
the incontinence and/ or voiding frequency decreased
50% or more. While these studies are small, the effects
of PTNS appear to be short term. And as the van der
Pal authors indicate, continuous PTNS may be necessary.
Finally, Finazzi and colleagues found no differences
in outcomes in 35 patients randomized to PTNS weekly
versus 3 times per week. (4) The authors noted patients
in both treatment groups had subjective improvements
after six to eight sessions of PTNS suggesting more
frequent treatment initially may result in earlier
achievement of desired effects even though the frequency
of PTNS did not influence the final outcomes in this
study.
Van der Pal and colleagues published an analysis of
quality of life questionnaires from 29 patients who
were treated with PTNS (3 times per week for 4 weeks)
for urge urinary incontinence. (5) Information from
Figure 1 of the article indicates that at least 12
of the subjects had either no change or an increase
in the number of pads used. The authors report that
they are currently conducting a randomized double-blind
placebo-controlled trial. Another study assessed the
efficacy of 12 weeks (1 time per week) of PTNS in 15
patients with chronic pelvic pain in an open prospective
clinical trial. (6) The study found subjective improvements
in VAS pain scores (8.1 to 4.1) and VAS urgency (4.5
to 2.7), with no change in the number of voids or bladder
volume. Since these subjective improvements may be
due to placebo, double-blinded controlled trials are
needed. In addition, since questions remain about the
long-term efficacy of PTNS, longer follow-up will be
needed to evaluate this procedure.
Peters et al published a randomized controlled blinded
pilot study to validate and assess the feasibility
of a sham device for PTNS. (7) This study enrolled
30 healthy volunteers. Although this study did not
focus on the clinical efficacy of PTNS for the treatment
of voiding dysfunction, it does facilitate potential
improvement in design for larger randomized controlled
trials over an adequate period of time with consistent
parameters.
In conclusion, randomized trials with appropriate
control groups are needed to determine the durability
and short and long-term effects of PTNS on voiding
dysfunction. Evidence from clinical series tends to
overestimate treatment effect. These studies do not
account for placebo effects or for dropouts by using
intent-to-treat analysis. Randomized controlled clinical
trials are needed to control for the effects of bias
and to demonstrate the efficacy of PTNS. Additionally,
further randomized trials are needed to determine appropriate
treatment periodicity. Clinicaltrials.gov indicates
that the OrBIT trial, using PTNS for the overactive
bladder, should be completed September, 2008. (8) Results
from this trial are not yet published.
Note: The policy criteria apply to patients with interstitial
cystitis, as they may be considered candidates for
PTNS therapy based on the presence of urgency and frequency
alone.
References
- BlueCross and BlueShield Association Medical Policy
Reference Manual, Policy No. 7.01.106
- Nuhoglu
B, Fidan V, Ayyildiz A, et al. Stoller afferent nerve
stimulation in woman with therapy resistant over
active bladder; a 1-year follow up. Int Urogynecol
J Pelvic Floor Dysfunct.
2006;17(3):204-207
- Van der Pal F, van Balken MR, Heesakkers
JP, et al. Percutaneous tibial nerve stimulation
in the treatment of refractory overactive bladder
syndrome: is maintenance treatment necessary? BJU
Int.
2006;97(3):547-50
- Finazzi Agro E, Campagna A, Sciobica
F et al. Posterior tibial nerve stimulation: is
the once-a-week protocol the best option? Minerva
Urol Nefrol 2005;57(2):119-23
- Van der Pal F, van Balken MR, Heesakkers JP et
al. Correlation between quality of life and voiding
variables in patients treated with percutaneous tibial
nerve stimulation. BJU Int 2006; 97(1):113-6
- Kim SW, Paick JS, Ku JH. Percutaneous posterior
tibial nerve stimulation in patients with chronic
pelvic pain: a preliminary study. Urol Int 2007;
78(1):58-62
- Peters K, Carrico D, Burks F, et al. Validation
of a Sham for Percutaneous Tibial Nerve Stimulation
(PTNS). Neurourol Urodyn 2008; July 31 [Epub
ahead of print]
- Clinicaltrials.gov search for PTNS: http://www.clinicaltrials.gov/ (verified
09/09/08)
Cross References
Pelvic
Floor Stimulation as a Treatment of Urinary Incontinence,
Regence Medical Policy Manual, Allied Health, Policy
No. 4
Stimulation
of the Sacral Anterior Root Combined with Posterior
Sacral Rhizotomy in Patients with Spinal Cord Injury,
Regence Medical Policy Manual, Surgery, Policy No.
112
Transvaginal
Radiofrequency Bladder Neck Suspension for Urinary
Stress Incontinence, Regence Medical Policy
Manual, Surgery, Policy No. 130
Sacral
Nerve Modulation/Stimulation for Pelvic Floor Dysfunction,
Regence Medical Policy Manual, Surgery, Policy No.
134
| Codes |
Number |
Description |
| The correct CPT code to use for PTNS
is the unlisted CPT code 64999. CPT codes for percutaneous
implantation of neurostimulator electrodes (i.e.,
64553, 64555, 64560, 64561,64565, 64590) are not
appropriate since PTNS uses percutaneously temporarily
inserted needles and wires rather than percutaneously
implanted electrodes that are left in place. |
| CPT |
64999 |
Unlisted procedure, nervous system |
| |
97014 |
Application of a modality to one or more areas;
electrical stimulation (unattended) |
| |
97032 |
Application of a modality to one or more areas;
electrical stimulation (manual), each 15 minutes |
| HCPCS |
L8680 |
Implantable neurostimulator electrode,
each |
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