BlueCross and BlueShield of Montana Medical Policy/Codes
Temporary Prostatic Stent
Chapter: Medicine: Treatments
Current Effective Date: August 27, 2013
Original Effective Date: March 18, 2012
Publish Date: August 27, 2013
Revised Dates: June 28, 2013
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™ (AbbeyMoor Medical, Parkers Prairie, MN) 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™” (AbbeyMoor Medical) 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.

Policy

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.

Coverage

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

Rationale

Literature Review

The following is a summary of the key literature to date.

One randomized controlled trial (RCT) that evaluates the Spanner (Sp) prostatic stent has been published. Findings were published in 2008 by Dineen and colleagues. (1) The study evaluated the impact of the Spanner stent on management of voiding symptoms, irritative symptoms, and bother after transurethral microwave thermotherapy (TUMT). (1) 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 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.”

Summary

Data are inconclusive regarding the role of temporary prostatic stents for prostatic obstructive conditions. This procedure has not been shown to improve the net health outcome.

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.

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. 

Rationale for Benefit Administration
 
ICD-9 Codes

Experimental, investigational and unproven for all diagnoses.

ICD-10 Codes
0V9080Z.  Experimental, investigational and unproven for all diagnoses 
Procedural Codes: 53855
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.
  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.
  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.
  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.
  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.
  6. Vanderbrink BA, Rastinehad AR, Badlani GH. Prostatic stents for the treatment of benign prostatic hyperplasia. Curr Opin Urol 2007; 17(1):1-6.
  7. Temporary Prostatic Stent. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (September 2012) Medicine 2.01.70.
History
January 2012 New policy for BCBSMT
August 2013 Policy formatting and language revised.  Policy statement unchanged.
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Temporary Prostatic Stent