CAM 20170

Temporary Prostatic Stent

Category:Medicine   Last Reviewed:March 2020
Department(s):Medical Affairs   Next Review:March 2999
Original Date:November 2004    

Description:
Prostatic obstruction is a common condition with a variety of etiologies. Benign prostatic hyperplasia (BPH) is the most common etiology, but obstruction may also occur acutely after surgical treatment for 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/Overview:
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 SpannerTM (Abbeymoore Medical) temporary prostatic stent is composed of a proximal balloon to prevent distal displacement, a urine port situated cephaled 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 side 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 an office procedure without anesthesia.

The Spanner temporary prostatic stent received approval from the U.S. Food and Drug Administration (FDA) in December 2006 through the premarket approval process. The device is intended "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. " In June 2009, the FDA approved a PMA supplement allowing for a structural change in the Spanner device that includes a change to a high durometer silicone sleeve, which the company states adds to the patient's comfort with the device.

Note: This policy does not address the use of permanent prostatic stents. The Urolume is an example of an FDA-approved permanent prostaticstent. This wire mesh device is placed into the urethra, where it is slowly incorporated into the urethral wall. This 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.

Related Policies
70152 Transurethral Microwave Thermotherapy

Policy:
A temporary prostatic stent is considered INVESTIGATIONAL.

Policy Guidelines
Effective in 2010, there is a category I CPT code for the procedure:

53855: Insertion of a temporary prostatic urethral stent, including urethral measurement.

Between 2005 and 2010, a Category III CPT code was available that described the use of a temporary prostatic stent.

0084T: Insertion of a temporary prostatic urethral stent

Benefit Application
BlueCard®/National Account Issues
State or federal mandate (i.e., FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational, and, thus, these devices may be assessed only on the basis of their medical necessity.

Rationale:
Literature Review
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 three 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 seven to 10 days before TUMT and repeated one, two, four (stent removal), five and eight 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 one, two and four 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 (two 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 percent) had unsatisfactory outcomes; the remaining 37 percent were considered to have had satisfactory outcomes, either with a stent in situ after a mean of five 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 two 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 percent. In patients with the BPS-2, migration occurred in 5 percent. 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 one 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 two 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. Therefore, the use of temporary prostatic stents is considered investigational.

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.

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. 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):1040-6.
  3. 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. 
  4. 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.
  5. 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.
  6. van Dijk MM, Mochtar CA, Wijkstra J, 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.
  7. Vanderbrink BA, Rastinehad AR, Badlani GH. Prostatic stents for the treatment of benign prostatic hyperplasia. Curr Opin Urol 2007; 17(1):1-6.
  8. Corica AP, Larson BT, Sagaz A et al. A novel temporary prostatic stent for the relief of prostatic urethral obstruction. BJU Int 2004; 93(3):346-8.
  9. American Urological Association. Guideline on the management of benign prostatic hyperplasia.
  10. Chao ST, Angermeier K, Klein EA et al. Prophylactic uretheral stenting with memokath 028SW in prostate cancer patients undergoing prostate 125l seed implants: phase I/II study. J Contemp Brachytherapy 2011; 3(1):18-22.

Coding Section

Codes Number Description
CPT 53855 Insertion of a temporary prostatic urethral stent, including urethral measurement
ICD-9 Diagnosis   Investigational for all relevant diagnoses
  599.6 Urinary obstruction, unspecified
  600.01 Hypertrophy (benign) of prostate with urinary obstruction
  600.91 Hyperplasia of prostate, unspecified, with urinary obstruction
ICD-10-CM (effective 10/01/15)   Investigational for all relevant diagnoses
  N40.0-N40.1 Enlarged prostate (EP) code range
  N13.8 Other obstructive and reflux uropathy
  N13.9 Obstructive and reflux uropathy, unspecified
ICD-10-PCS (effective 10/01/15)   ICD-10-PCS codes are only used for inpatient services. There is no specific code ICD-10-PCS code for this procedure.
  0V9080Z Surgical, male reproductive system, drainage, prostate, via natural or artificial opening, endoscopic, drainage device

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.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology© American Medical Association.  All Rights Reserved" 

History From 2014 Forward     

03/02/2020 

Annual review. No change to policy intent. 

03/01/2019 

Annual review. No change to policy intent. 

03/19/2018 

Annual review. No change to policy intent. 

03/02/2017 

Annual review, no change to policy intent. 

03/03/2016 

Annual review, no change to policy intent. 

03/12/2015 

Annual review, no change to policy intent. Added regulatory status and coding. 

03/12/2014

Annual review. Added related polcies and benefit application. No change to policy intent.


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