Medical Policies - OBGYN


Tactile Biomechanical Sensor Imaging

Number:OB402.034

Effective Date:10-15-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Tactile biomechanical sensor imaging (transvaginal biomechanical imaging) is considered experimental, investigational and/or unproven for all indications, including but not limited to the evaluation of pelvic organ prolapse, stress urinary incontinence, pelvic floor conditions, pelvic pain, prior and following laser/radiofrequency vaginal procedures, vaginal wall rejuvenation, and vaginal/pelvic floor deviation.

Tactile biomechanical sensor imaging is considered experimental, investigational and/or unproven to evaluate any non-gynecological condition(s), including but not limited to the prostate, bladder or breast tissue.

Description:

Pelvic floor problems can occur when the pelvic floor muscles are stretched, weakened or too tight. Some women have weak pelvic floor muscles from an early age, while others notice problems after certain life stages such as pregnancy, childbirth or menopause. Some women have pelvic floor muscles that are too tight and cannot relax. This can be made worse by doing squeezing exercises and overworking the muscles without learning how to relax.

Background

The Kegel perineometer or vaginal manometer was developed as an instrument to measure the strength of voluntary contractions of the pelvic floor muscles. Using the perineometer ascertains the air pressure inside the vagina when asking the woman to squeeze as hard as possible, which indicates whether doing Kegel exercises would be beneficial. Assessment of the pelvic floor strength can also be performed digitally by the physician during a gynecological exam digitally to identify women with fascial defects of the pelvic floor. The Kegel perineometer and digital examinations may help to identify those women at risk of genital prolapse or urinary incontinence.

Approximately 50% of women in the U.S. are affected by pelvic organ prolapse (POP). The Vaginal Tactile Imager (VTI) allows for the acquisition of the pressures applied to the vaginal wall along with visualization of vaginal and pelvic floor support structures, and to record pelvic floor muscle contraction patterns, which may be useful to evaluate POP. The probe is equipped with 96 pressure/tactile sensors, a motion system and a temperature controller. The VTI allows for the assessment of tissue elasticity, pelvic floor support, muscle tone and function. Advanced Tactile Imaging has reported the VTI is used for the following indications: (1, 2)

POP: to characterize and localize its development;

Stress urinary incontinence (SUI): to quantify pelvic muscle defects that contribute to SUI;

POP or SUI Treatment Failure: to investigate the reason for pelvic floor treatment failure;

Pelvic Pain: to identify factors contributing to pelvic floor pain;

Vaginal or pelvic floor deviation of position: to recognize and quantify an abnormal deviation of position of the vaginal wall septum or pelvic floor structure;

Surgical outcomes: to assess post-surgical results of the pelvic floor, such as changes in anatomy, tissue elasticity, and function;

Laser or radiofrequency (RF) procedure outcomes: to evaluate vaginal conditions pre-operatively and post-operatively of laser and RF treatment;

Aesthetic outcomes: to assess vaginal and pelvic floor support pre-operatively and post-operatively of rejuvenation treatments;

Physiotherapy outcomes: to assess vaginal and pelvic floor support following Kegel or other pelvic floor exercises/applied treatments; or

Post-military or sport impact: to monitor pelvic floor conditions under heavy, repetitive loads or pressures.

Regulatory Status

The VTI device developed by Advanced Tactile Imaging (Trenton, N.J.), is a diagnostic perineometer test to acquire vaginal pressure patterns and visualization of vaginal elasticity, tone, and strength. (3) The U.S. Food and Drug Administration (FDA) cleared the VTI device and system on May 28, 2015 as a class II device through the 510(k) marketing clearance process. The FDA determined that this device was substantially equivalent to existing perineometer devices. FDA Product Code: HIR.

Rationale:

The medical policy was developed based on a MedLine search of peer-reviewed scientific literature and review of clinical trials completed through November 2017. The following is a summary of the key literature to date.

Vaginal and Pelvic Floor Evaluation

The U.S. Food and Drug Administration (FDA) clearance process reviewed 3 clinical trials summarized in Table 1 below for the Vaginal Tactile Imager (VTI). (3)

Table 1. Vaginal Tactile Imager Completed Clinical Trials Used for FDA Clearance.

NCT Number

Study Title

Study Type

No. of Patients Studied

Date Completed

NCT01111916

Development Study Using Vaginal Tactile Imager

Phase I Observational

31

Sep 2010

NCT01491334

Validation of Transvaginal Tactile Imager

Phase II Observational

158

Jan 2014

NCT01848626

Study with Advanced Vaginal Tactile Imager

Phase III Observational

22

Jan 2014

Table Key:

NCT: National Clinical Trial;

No: number.

In 2010, a pilot study reported 13 patients assessed using a “novel” prototype of the VTI. (4, 5) In this study of laser vaginal therapies, VTI measurements were completed prior and following the treatments. The vaginal tissue elasticity improved in 8 of 12 patients (50% to 1400%). Pelvic floor support improved (75% to 480%). Four patients had unchanged measurements. Other measurements were assessed, improved voluntary muscle contractions in 7 patients (63% to 233%); improved involuntary contractions during cough in 5 patients (84% to 330%); improved vaginal and pelvic floor support in 6 patients after a single laser treatment (>50%).

The Phase I study was published in 2012 by Egorov et al. (6) Thirty-one study subjects with normal and prolapsed conditions were included in the study. The vaginal tissue elasticity was calculated from partial gradients in the resulting 3-dimensional (3-D) tactile images. Average values, using Young’s elastic modulus, for tissue elasticity for the anterior and posterior compartments for normal conditions were 7.4 ± 4.3 kPa and 6.2 ± 3.1 kPa respectively. For stage III pelvic organ prolapse (POP), the average values were 1.8 ± 0.7 kPa and 1.8 ± 0.5 kPa. The authors concluded VTI may serve as a means for 3-D imaging to assess vaginal elasticity and POP.

In 2015, van Raalte and Egorov reported on the Phase III results prior to the study results of Phase II. (7) This study evaluated 22 patients with normal and prolapsed conditions. Eleven parameters were identified that served as potential markers to characterize female pelvic floor conditions. These parameters correlated with prolapsed conditions, patient age, and parity. Their conclusion suggested that the tactile imaging markers, such as pressure, pressure gradient, and dynamic pressure response during muscle contraction may be used to quantitatively characterize female pelvic floor conditions.

Vicente et al. published a follow-up study in 2017. (8) This observational study of normal pelvic support was compared to POP (stages I-IV). All 138 patients were successfully examined with VTI and a set of 31 parameters were evaluated. The acquired VTI data was quantitatively characterized for the pelvic muscles and ligamentous structures, a biomechanical assessment of functional anatomy. The authors believe VTI will assist to optimize treatment of diseased conditions such as POP, incontinence, atrophy, and some forms of pelvic pain.

Section Summary: Vaginal and Pelvic Floor Evaluation

The literature thus far consists of the results of the pilot study and 2 clinical trials (Stages I and III). The Stage II study has not been published. There were no comparative studies of the VDI to digital examination or VDI to other types of diagnostic testing, such as manometry, ultrasound, or magnetic resonance imaging.

Non-Gynecological Evaluation Using Biomechanical Tactile Imaging

Biomechanical tactile imaging has been explored in 2 studies – prostate, bladder and breast tissue.

Peng et al. reported on the possibility of using tactile sensor testing on cancerous cells found in the prostate gland. (9) Their conclusion that cancerous cells display stiffness associated with increased aggressiveness of the cancer. Their technology review included testing prostate cancer, benign prostatic hyperplasia and prostatic zone anatomy. The preliminary results showed the tactile imaging device could differentiate the stiffness of different tissues.

Breast, bladder and prostate tissue tactile mechanical imaging was evaluated by Sarvazyan and Egorov in 2009. (10) They proposed mechanical imaging with tactile or elasticity sensors would be valuable to visualize and evaluate prostate, bladder and breast cancer screening or conditions.

Section Summary: Non-Gynecological Evaluation Using Biomechanical Tactile Imaging

Additional studies are needed to evaluate the applications, strengths, and limitations of this type of tactile imaging for cancer screening or diagnostic use.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 2.

Table 2. Summary of Key Trials

NCT No.

Trial Name

Planned Enrollment

Completion Date

Ongoing

NCT02925585

Vaginal Tactile Imaging

150

Sep 2018

NCT03311685

Vaginal Tactile Imaging for the Assessment of Pelvic Organ Prolapse Repair Efficiency

60

Mar 2019

NCT03301818

Vaginal Elasticity Assessment Before and After Surgical Repair for Urinary Stress Incontinence

50

Mar 2019

Table Key:

NCT: National Clinical Trial;

No: number.

Professional Guidelines and Position Statements

There are no professional guidelines and position statements that support the use of VTI or biomechanical tactile imaging for any gynecological or non-gynecological condition.

Summary of Evidence

The available evidence published in the peer-reviewed literature is inadequate to conclude utilization of vaginal tactile imaging (VTI), as a technique to assess the functional anatomy of the vagina and pelvic floor. Comparative studies are needed to assess health outcomes using this device. Therefore, the use VTI is considered experimental, investigational and/or unproven to evaluate any gynecological condition.

The lack of available evidence to conclude utilization of tactile biomechanical imaging, as a technique to screen for or diagnose breast, bladder, or prostate cancer is inadequate. Clinical trials are needed to assess health outcomes using this technique. Therefore, the use of tactile biomechanical sensor imaging is considered experimental, investigational and/or unproven to evaluate any non-gynecological condition.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

0487T

HCPCS Codes

None

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Vaginal Tactile Imager – Product information. Advanced Tactile Imaging; Trenton, N.J. Available at: <http://www.tactile-imaging.com> (accessed on November 28, 2017).

2. FDA – Vaginal Tactile Imager 510(k) Summary Approval Letter (K142355; May 28, 2017). U.S. Food and Drug Administration, Center for Devices and Radiological Health. Available at: <http://www.fda.gov> (accessed on November 28, 2017).

3. FDA – Vaginal Tactile Imager Product Classification Premarket Notification (August 25, 2014). U.S. Food and Drug Administration, Center for Devices and Radiological Health. Available at: <http://www.fda.gov> (accessed on November 28, 2017).

4. Egorov V, van Raalte H, Sarvazyan AP. Vaginal tactile imaging. IEEE Trans Biomed Eng. Jul 2010; 57(7):1736-44. PMID 20483695

5. van Raalte H. New biomechanical approach characterizes vaginal conditions. Anesth Guide. May/Jun 2017. Available at: <http://www.miinews.com> (accessed on November 28, 2017).

6. Egorov V, van Raalte H, Lucente V. Quantifying vaginal tissue elasticity under normal and prolapsed conditions by tactile imaging. Int. Urogynecol J. Apr 2012; 23(4):459-66. PMID 22072417

7. van Raalte H, Egorov V. Characterizing female pelvic floor conditions by tactile imaging. Int Urogynecol. J. Apr 2015; 26(4):607-9. PMID 25344223

8. Vicente V, van Raalte H, Murphy M, et al. Biomechanical paradigm and interpretation of female pelvic floor conditions before treatment. Int J Womens Health. 2017; 9:521-50. PMID 28831274

9. Peng Q, Omata S, Peehl DM, et al. Stiffness mapping prostate biopsy samples using a tactile sensor. Conf Proc IEEE Eng Med Biol Soc. 2011:8515-8. PMID 22256325

10. Sarvazyan AP, Egorov V. Mechanical imaging in medical applications. Conf Proc IEEE Eng Med Biol Soc. 2009:1975-8. PMID 19964026

Policy History:

DateReason
10/15/2018 Reviewed. No changes.
1/1/2018 New medical document. Tactile biomechanical sensor imaging (transvaginal biomechanical imaging) is considered experimental, investigational and/or unproven for all indications, including but not limited to the evaluation of pelvic organ prolapse, stress urinary incontinence, pelvic floor conditions, pelvic pain, prior and following laser/radiofrequency vaginal procedures, vaginal wall rejuvenation, and vaginal/pelvic floor deviation. Tactile biomechanical sensor imaging is considered experimental, investigational and/or unproven to evaluate any non-gynecological condition(s), including but not limited to the prostate, bladder or breast tissue.

Archived Document(s):

Title:Effective Date:End Date:
Tactile Biomechanical Sensor Imaging01-01-201810-14-2018
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