| 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: 05/11/2010 |
Effective Date: 06/01/2010 |
| Next Review Date:
06/2011 |
|
| |
IMPORTANT REMINDER
Regence Medical Policies are developed to provide guidance for members and providers regarding
coverage in accordance with contract terms. Benefit determinations are based in all cases on
the applicable contract language. To the extent there may be any conflict between the Medical
Policy and contract language, the contract language takes precedence.
PLEASE NOTE: Contracts exclude from coverage, among other things, services or procedures that
are considered investigational or cosmetic. Providers may bill members for services or
procedures that are considered investigational or cosmetic. Providers are encouraged to inform
members before rendering such services that the members are likely to be financially responsible
for the cost of these services.
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. The tibial
nerve is accessed using a fine-needle electrode inserted slightly above
the ankle, and low-voltage electrical stimulation is delivered. The course
of treatment is typically 10–12 weeks of 30-minute weekly sessions.
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. Altering the function of the posterior tibial nerve
with posterior tibial nerve stimulation is believed to improve voiding
function and control.
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). In
addition, PTNS has been has been proposed for the treatment of urgency
and frequency caused by interstitial cystitis.
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 Regence Allied Health policy No.
4.
Policy/Criteria
Posterior tibial nerve stimulation for urinary dysfunction, including
but not limited to urinary frequency, urgency, incontinence and retention,
is considered investigational.
Scientific Background [1]
Study selection criteria for the evaluation of evidence
on posterior tibial nerve stimulation (PTNS) included
the following:
- 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 and colleagues
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 and colleagues published a randomized controlled
blinded pilot study to validate and assess the feasibility
of a sham device for PTNS. [7] Ten of the 30 healthy
volunteers (33%) correctly identified the sham procedure.
This percentage is below the 50% that could be expected
by chance, so the authors concluded that the procedure
was a feasible sham. Another randomized trial,
also by Peters and colleagues, was supported by Uroplasty,
Inc. and was a non-blinded comparison of PTNS and extended-release
tolterodine (Detrol LA) for treatment of overactive
bladder syndrome. [8] The study included 100 patients,
over 90% women, with at least eight voids per 24 hours
(mean 12.3). The primary outcome was the non-inferiority
of PTNS in the mean reduction in the number of voids
per 24 hours after 12 weeks of treatment. Study findings
showed non-inferiority of PTNS; however, these findings
were based on results for only 84 patients. The decrease
in voids per day was 2.4 in the PTNS group and 2.5
in the tolterodine group. The study reported mixed
findings for a number of secondary outcomes, some of
which were based on patient reports. However, these
results are unreliable because they could have been
affected by the patient reports having been obtained
in person for the PTNS group as part of their weekly
session but obtained over the phone for the medication
group. There were no statistically significant differences
in the PTNS and tolterodine groups for other symptoms
recorded in the voiding diary. This finding includes
episodes of nocturia (-0.7 and -0.6, respectively)
and episodes of moderate to severe urgency per day
(-2.2 and -2.9, respectively). There was a statistically
significant difference in the proportion of patients
reporting improvement or cure in symptoms (79.5 vs.
54.8%). Limitations of this study include the lack
of a sham/placebo group both to mitigate the potential
bias due to subjective outcomes and to evaluate whether
either treatment is better than placebo. In addition,
the results for 16% of the original 100 patients is
not reported, data were not reported for compliance
with medication therapy, and the study includes short-term
efficacy only.
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, blinded
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. [9] Results
from this trial are not yet published.
References
- TEC Assessment 1996. "Transcutaneous or Percutaneous
Electrical Stimulation in the Treatmetn of Chronic
and Postoperative Pain." BlueCross BlueShield
Association Technology Evaluation Center, Vol. 11
Tab. 21.
- Nuhoglu B, Fidan V, Ayyildiz A, Ersoy E, Germiyanoglu
C. Stoller afferent nerve stimulation in woman with
therapy resistant over active bladder; a 1-year follow
up. Int Urogynecol J Pelvic Floor Dysfunct.
2006 May;17(3):204-7. PMID: 16049624
- van der Pal F, van Balken MR, Heesakkers JP, Debruyne
FM, Bemelmans BL. Percutaneous tibial nerve stimulation
in the treatment of refractory overactive bladder
syndrome: is maintenance treatment necessary? BJU
Int. 2006 Mar;97(3):547-50. PMID: 16469023
- 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 Jun;57(2):119-23. PMID: 15951736
- van der Pal F, van Balken MR, Heesakkers JP, Debruyne
FM, Kiemeney LA, Bemelmans BL. Correlation between
quality of life and voiding variables in patients
treated with percutaneous tibial nerve stimulation. BJU
Int. 2006 Jan;97(1):113-6. PMID: 16336339
- 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. PMID: 17192734
- Peters K, Carrico D, Burks F. Validation of a sham
for percutaneous tibial nerve stimulation (PTNS). Neurourol
Urodyn. 2009;28(1):58-61. PMID: 18671297
- Peters KM, Macdiarmid SA, Wooldridge LS, et al.
Randomized trial of percutaneous tibial nerve stimulation
versus extended-release tolterodine: results from
the overactive bladder innovative therapy trial. J
Urol. 2009 Sep;182(3):1055-61. PMID: 19616802
- cited 3/15/10]; Available from: http://www.clinicaltrials.gov/ct2/search
Cross References
Pelvic
Floor Stimulation as a Treatment of Urinary Incontinence,
Regence Medical Policy Manual, Allied Health, Policy
No. 4
Biofeedback, Regence Medical Policy Manual, Allied
Health, Policy No. 32
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 |
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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