Medical Policies - Medicine


Temporary Prostatic Stent

Number:MED201.025

Effective Date:06-15-2018

Coverage:

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

A temporary prostatic stent is considered experimental, investigational and/or unproven.

Description:

Prostatic obstruction is a common condition with a variety of etiologies. Obstruction may occur acutely after surgical treatment for benign prostatic hyperplasia (BPH), prostatic cancer, or after radiation therapy. Intraprostatic stenting has been investigated as a short-term treatment option, permitting volitional urination as an alternative to the commonly used Foley catheter, in which urine is collected in an external bag.

Background

In addition to volitional urination, the ideal temporary stent would be one that could be easily inserted and removed without migration, permitting adequate emptying of the bladder without disrupting the external sphincter such that continence could be maintained.

The Spanner™ temporary stent is composed of a proximal balloon to prevent distal displacement, a urine port situated cephalad to the balloon, and a reinforced stent of various lengths to span most of the prostatic urethra. The distal anchor is shaped like a teardrop and positioned in the distal meatus. As the patient voids, the force of the urine compresses the device against the sides of the meatus, thus minimally obstructing the urine flow. A distal anchor mechanism is attached by sutures. Finally, a retrieval suture extends to the meatus and deflates the proximal balloon when pulled. The insertion of this device may be as an outpatient procedure with the patient under topical anesthesia or as an office procedure without anesthesia.

NOTE: This policy does not address the use of permanent prostatic stents. The Urolume® (AMS, Minneapolis, MN) is an example of a U.S. Food and Drug Administration (FDA)-approved permanent prostatic stent. This wire mesh device is placed into the urethra, where it is slowly incorporated into the urethral wall. The policy only addresses temporary stents, which are designed to be removable.

Regulatory Status

In December 2006, the device “The Spanner™” (SRS Medical N. Billerica, MA) was approved by the FDA through the premarket approval process for temporary use (up to 30 days) to maintain urine flow and allow voluntary urination in patients following minimally invasive treatment for BPH and after initial post-treatment catheterization. Since then, the FDA has approved 12 PMA supplements describing changes to the device’s design (5) and manufacturing process.

Rationale:

This policy was originally developed in 2007 and has been updated with searches of scientific literature through April 2018. The following is a summary of the key literature to date.

Results from a randomized controlled trial (RCT) by Dineen et al. (1) evaluated the Spanner (Sp) prostatic stent. The study evaluated the impact of the Spanner stent on management of voiding symptoms, irritative symptoms, and outcome after transurethral microwave thermotherapy (TUMT). Patients (n=186) were randomly assigned to the Sp (n=100) or standard of care (SOC, n=86) after TUMT and 3 to 10 days of routine catheterization. After catheter removal, the SOC group received no further treatment until follow-up visits. Primary outcomes evaluated included the International Prostate Symptom Score (IPSS) voiding subscore, IPSS irritative subscore, voiding diary data, and Benign Prostatic Hyperplasia Impact Index 7 to 10 days before TUMT and repeated 1, 2, 4 (stent removal), 5, and 8 weeks after stent insertion. The IPSS voiding and irritative subscores showed statistically significant improvement at week 1 for the Sp group but no significant differences at weeks 2, 4, 5, and 8. For the individual IPSS voiding and irritative ;questions of incomplete emptying, there were no significant differences between the Sp and SOC groups at any visit. Overall, individual IPSS irritative questions did not differ significantly between the Sp and SOC groups at 1, 2, and 4 weeks after stent insertion. From the voiding diary data, the feeling of incomplete emptying, terminal dribble, and leakage were not significantly different between the Sp and SOC groups at any visit. On the Benign Prostatic Hyperplasia Impact Index, the Sp group was less bothered during the time of stent use (2 weeks). The remaining weeks for this index were similar in both groups. While this study showed statistically significant changes in some outcome measures, the study has a number of limitations. First, participants or practitioners were not blinded to the treatment, so potential biases could have occurred on reporting the outcome measures. Second, no information is given about dropout rates or missing data. Finally, the clinical significance of many of the findings is not known. Thus, these data are inconclusive regarding the role of temporary prostatic stents for prostatic obstruction conditions.

Another report on the Spanner stent, published in 2007, described repeated temporary stent use in 43 consecutive patients with bladder-outlet obstruction who were unfit for surgery. (2) It was reported that more than half of the patients (63%) had unsatisfactory outcomes; the remaining 37% were considered to have had satisfactory outcomes, either with a stent in situ after a mean of 5 changes or stent-free after a successful voiding trial.

In 2006, Kijvikai and colleagues conducted a study in Europe to assess the efficacy and safety of 2 versions of a blind placement temporary prostatic stent (BPS-1 and BPS-2) in the treatment of patients with benign prostatic obstruction. (3) A total of 55 men were enrolled in the trial. Spontaneous voiding was achieved in all patients immediately after stent insertion, with improvements in voiding parameters and symptom scores. In patients with the BPS-1, migration occurred in 85%. In patients with the BPS-2, migration occurred in 5%. The median indwelling time of the stent was 16 days for the BPS-1 and 38 days for the BPS-2. Removal was successful in all but 1 case (BPS-2). The authors concluded that the BPS-1 and BPS-2 are not suitable for clinical practice because of the significantly high migration rate (BPS-1) and voiding parameters and symptom scores (BPS-2) that were not significantly improved. Given the study location and lack of U.S. Food and Drug Administration (FDA) approval for these devices, these data are insufficient to draw conclusions regarding the use of these devices.

In 2005 and 2006, van Dijk and colleagues conducted studies for 2 designs (hourglass-shaped and bell-shaped) of removable stents in a total of 143 subjects. (4, 5) Unsatisfactory outcomes were reported for both models; the stents required early removal due to migration and other sources of pain, with a median retention of less than 105 days.

In 2008, Vanderbrink and colleagues published a review of the use of the temporary prostatic stent. (6) The report concluded that “…. a major disadvantage of temporary prostatic stents is that they have a small lumen that can result in urinary retention secondary to clot–induced impairment of catheter patency, when placed in the immediate post-TUMT treatment.”

ECRI Institute

In April 2018 ECR1 release a Product Brief titled: Spanner Prostatic Stent (SRS Medical) for Maintaining Urine Flow after Treatment for Benign Prostatic Hyperplasia (10).

ECRI searched PubMed, EMBASE, and selected web-based resources for documents relevant to this topic and published between January 1, 2000 and April 11, 2018. Reviewed were full-text of 1 RCT and the abstract of 1 retrospective case series; studies reported on 211 patients. Also reviewed was a published abstract that reported additional outcomes of the RCT.

The authors of this product brief noted that the studies provide some evidence suggesting that Spanner may be safe and effective for temporary lower urinary tract symptoms (LUTS) relief after benign prostatic hypertrophy (BPH) thermotherapy. A multicenter RCT (n = 186) (11) used two validated questionnaires to compare urinary symptoms in patients treated with Spanner placement or standard medical therapy for one month following TUMT and successful Foley catheter removal. Patients in the Spanner group reported better overall scores during treatment and reported large symptom relief more often than patients in the control group (44% versus 28% of patients). In addition, patients reported better irritative symptom and QOL IPSS subscores one month after Spanner removal; suggesting that Spanner results in durable benefits. Patients experienced similar rates of serious AEs in both groups. The most common serious adverse events (AEs) with Spanner included urinary tract infection (15% of patients), urinary retention (6%), and stent migration (5%).

A smaller, retrospective case series (n = 25) (12) reported no serious adverse events at Spanner removal in patients who had the device for 2 to 28 days (mean 16). Patients and physicians reported high rates of satisfaction (79% to 87%) with the device in the RCT.

Both studies also reported on urinary flow parameters such as peak flow rate post-voiding residual volume. However, ECRI did not consider these findings in their assessment because flow metrics are surrogate outcomes that do not clearly predict patient-centered outcomes. Although urinary dysfunction generally results in flow metric changes, individual perception of these changes varies greatly; and clinical experts do not agree on the clinical value of urinary flow metrics. ECRI noted: “That while favorable, the evidence on Spanner is of insufficient quantity and quality to support conclusions. A multicenter RCT assessed patient-reported LUTS relief with Spanner. However, findings are at risk of bias because blinding patients to Spanner placement is not possible. Independent confirmation of findings in additional RCTs is needed for data to be a conclusive. Safety outcomes are at low risk of bias in the RCT, but a single small case series provides insufficient validation. Thus, additional studies of safety are needed. Furthermore, a significant evidence gap remains. No data are available to compare Spanner with alternative interventions such as indwelling Foley catheters and intermittent self-catheterization. Reviewed findings pertain only to TUMT and may not fully generalize to other interventions such as visual laser ablation of the prostate (VLAP) or interstitial laser coagulation of the prostate (ILC). Studies that address these gaps are needed to assess Spanner’s clinical utility.”

ECRI’s executive summary noted: “Very limited evidence from 1 randomized controlled trial (RCT) and 1 case series suggests that Spanner may be safe and relieve LUTS in patients who undergo TUMT. However, findings are at high risk of bias and additional studies are needed to confirm results and compare Spanner with indwelling Foley catheters, intermittent self-catheterization, and to validate use with other thermotherapy procedures. An ongoing study will not provide data to address evidence gaps.”

Summary of Evidence

Data are inconclusive regarding the role of temporary prostatic stents for prostatic obstructive conditions.

Practice Guidelines and Position Statements

Although previous versions of the American Urological Association guideline on the management of benign prostatic hyperplasia included a statement on temporary prostatic stents, this technology was not mentioned in the current version of the guideline (revised 2010). No other relevant practice guidelines or position statements were identified.

Two clinical studies were identified at ClinicalTrials.gov. The study entitled The Spanner Prostatic Stent and Patient's Quality of Life (SpannerQoL): NCT01705444 was last updated March 2016 noting that the study was completed. As of April 2018, ClinicalTrials.gov notes no “final results have not been posted”. In addition, the study titled: Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder Drainage in Men Unfit for Other Treatments has a status identified as “recruiting” with an estimated completion date of October 2018. (8, 9)

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

53855

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. Dineen MK, Shore ND, Lumerman JH, et al. Use of a temporary prostatic stent after transurethral microwave thermotherapy reduced voiding symptoms and bother without exacerbating irritative symptoms. Urology. 2008; 71(5):873-7. PMID: 18374395

2. Grimsley SJ, Khan MH, Lennox E, et al. Experience with the spanner prostatic stent in patients unfit for surgery: an observational study. J Endourol. 2007; 21(9):1093-6. PMID: 17941793

3. Kijvikai K, van Dijk M, Pes PL, et al. Clinical utility of "blind placement" prostatic stent in patients with benign prostatic obstruction: a prospective study. Urology. 2006; 68(5):1025-30. PMID: 17113894

4. Van Dijk MM, Mochtar CA, Wijkstra H, et al. Hourglass-shaped nitinol prostatic stent in treatment of patients with lower urinary tract symptoms due to bladder outlet obstruction. Urology. 2005; 66(4):845-9. PMID: 16230150

5. Van Dijk MM, Mochtar CA, Wijkstra H, et al. The bell-shaped nitinol prostatic stent in the treatment of lower urinary tract symptoms: experience in 108 patients. Eur Urol. 2006; 49(2):353-9. PMID: 16426738

6. Vanderbrink BA, Rastinehad AR, Badlani GH. Prostatic stents for the treatment of benign prostatic hyperplasia. Curr Opin Urol. 2007; 17(1):1-6. PMID: 17143103

7. Temporary Prostatic Stent. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (Archived September 2012) Medicine 2.01.70.

8. ClinicalTrials.gov. NCT01705444. The Spanner Prostatic Stent and Patient's Quality of Life (SpannerQoL). Available at: http: <www.clinicaltrials.gov> (last accessed April 26, 2018).

9. ClinicalTrials.gov. NCT02643849. Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder Drainage in Men Unfit for Other Treatments. Available at: http: www.clinicaltrials.gov (last accessed April 26, 2018).

10. ECRI Institute. Spanner Prostatic Stent (SRS Medical) for Maintaining Urine Flow after Treatment for Benign Prostatic Hyperplasia; 2018 April. (Product Brief).

11. Kessaris D, and Bellas A. Temporary prostatic stents as a replacement for urinary catheters following transurethral microwave thermotherapy: A retrospective review. Cogent Medicine. 2017; 4:1 Article Number: 1349355. EMBASE: 20170506341 [AN]

12. Shore ND, Dineen MK, Saslawsky MJ, et al. A temporary intraurethral prostatic stent relieves prostatic obstruction following transurethral microwave thermotherapy. J. Urol. 2007; 177(3):1040-1046. PMID: 17296408

Policy History:

DateReason
6/15/2018 Document updated with literature review. Coverage unchanged. References 10-12 added.
7/15/2017 Document updated with literature review. Coverage unchanged.
3/15/2016 Reviewed. No changes.
4/15/2015 Document updated with literature review. Coverage unchanged.
10/15/2013 Document updated with literature review. Coverage unchanged. Description and Rationale completely revised.
6/1/2008 Policy reviewed without literature review; new review date only. This policy is no longer scheduled for routine literature review and update.
9/15/2007 Revised/updated entire document
9/1/2005 New medical document

Archived Document(s):

Title:Effective Date:End Date:
Temporary Prostatic Stent07-15-201706-14-2018
Temporary Prostatic Stent03-15-201607-14-2017
Temporary Prostatic Stent04-15-201503-14-2016
Temporary Prostatic Stent10-15-201304-14-2015
Temporary Prostatic Stent06-01-200810-14-2013
Temporary Prostatic Stent09-15-200705-31-2008
Temporary Prostatic Stent09-01-200509-14-2007
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