Coverage Policy Manual
Policy #: 2004050
Category: Surgery
Initiated: October 2004
Last Review: September 2018
  Prostatic Stent, Temporary

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.  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 (Abbey Moor Medical) is a temporary prostatic stent.  The Spanner 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 device is inserted in an outpatient procedure under topical anesthetic. The FDA approved the Spanner device for marketing in January 2007.  The FDA decision was based on a multi-center, prospective, controlled, randomized clinical investigation designed to evaluate the safety and effectiveness of the SpannerTM to manage lower urinary tract symptoms (LUTS) and bladder emptying after transurethral microwave thermotherapy (TUMT) treatment after an initial period of catheterization.
 
This policy only addresses temporary stents.  For information about permanent stents please see policy 1997184, Prostatic Stents, Permanent (e.g., Urolume).

Policy/
Coverage:
Effective, October 2004
The use of a temporary prostatic stent does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For contracts without primary coverage criteria, the use of a temporary prostatic stent is considered investigational.  Investigational services are an exclusion in the member certificate of coverage.

Rationale:
There is minimal published data regarding the Spanner stent.  Corica and colleagues published the results of a case series of 30 patients who had obstruction of the prostatic urethra.  The Spanner stent was inserted and remained in situ for between 1 and 97 days (mean 57 days).  The maximum urinary flow improved from 8.2 to 11.6 mL/sec, while the mean post void residual improved form 312 to 112.3 mL.  There was temporary self limited incontinence during the first week in 11 of 30 patients.  There were no significant complications.
 
Van Dijk et. al. conducted studies for two new designs for removable stents in a total of 143 subjects.  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.  
 
Coverage for the FDA approved stent will be reviewed following publication of the study on which the FDA approval was based.  Based on review of information presented to the FDA, the overall changes noted (changes in IPSS scores, post-void residuals, and adverse events) in the group that received the temporary prostatic stent do not seem to represent a meaningful improvement in important clinical outcomes compared to standard care.  
 
Study participants were male patients older than 45 years of age that had undergone TUMT treatment for BPH.  Patients in the SpannerTM group used the device to manage LUTS and bladder emptying for a period of 28 days (4 weeks) after removal of their post-treatment Foley catheter.  Patients in the standard of care (SOC) group were sent home with no catheter or stent after removal of their post-treatment Foley catheter.  Study subjects were followed at 1, 2, and 4 weeks during the SpannerTM indwelling period and 1 and 4 weeks after the point of the SpannerTM removal.  SOC subjects were evaluated at the same time points.  
 
Patients were enrolled/randomized in the study at a visit 3 to 10 days following TUMT.  At this visit the Foley catheter that had been placed at the time of surgery was removed and patients were then randomized to receive the stent or standard of care if they had a successful voiding trial.  (A successful trial was defined as a post-void residual (PVR) < 250 ml with a mean voided volume of at least 100 ml.)  A total of 186 subjects (100 (54%) to the SpannerTM and 86 (46%) to SOC) were randomized at 9 clinical sites.  The investigation compared the two approaches during the post-TUMT recovery period.  
 
Primary effectiveness was measured by the change in the IPSS score from baseline (pre-procedure) to the average IPSS score at visits 1 and 2 weeks after insertion.  (IPSS: The International Prostate Symptom Score is based on 7 questions, total scores range from 0 – 35 points; 0-7 is mildly symptomatic, 8-19 is moderately symptomatic; 20-35 is severely symptomatic.)  Compared to preoperative scores of about 22 points, the score decreased by 7.28 points in the SpannerTM group compared to 4.42 points in the SOC group, a difference of 2.86 points (P=0.019).  (At 2 weeks after insertion, 14% of the experimental group and 6% of the control group were not available for follow-up.)  At 4 weeks after insertion, scores in the spanner group had decreased by 9.1 points versus 7.7 points in the control group (p=0.290) and at 4 weeks after removal (8 weeks after randomization and insertion), scores decreased by 14.1 versus 12.3 points, respectively, with p=0.234.  
 
Safety was measured by changes in post-void residual (PVR) from the PVR at randomization to the average of the PVR values at visits 1, 2, and 4 weeks after insertion.  Compared to PVR of ~60 cc at insertion, the volume decreased by 6.5mL in the SpannerTM group compared to an increase of 28.6 ml in the SOC group (P=0.001).  (At the time of stent removal, 18% of the experimental group and 9% of the control group were not available to follow-up.)  At 1 week after removal of the stent, volumes in the Spanner™ group had increased by 9.1 ml from baseline versus 12.8 ml in the control group, a difference that was not statistically significant (p=0.736).  
 
During the study there were 385 adverse events reported by 99 members of the Spanner™ group and 273 by 80 SOC patients.  For urologic adverse event requiring treatment, bacteriuria occurred in 16.0% of the SpannerTM group compared to 10.5% of the SOC group.  Micturition-burning was noted in 9.0% and 5.8%; perineal pain in 5.0% and 2.3%, respectively.  Urinary retention (not otherwise defined) occurred in 10% and 15.1%, respectively.  In the Spanner group, 2 of these occurred after removal of the temporary stent and 3% were associated with “migration.”  (Note: The FDA review did not include p-values for these results.)  
 
The FDA summary indicates the majority of adverse events (>75%) for both groups occurred during the weeks 1-4 following insertion, adverse events also occurred after removal of the device and included bleeding and hematuria, urinary frequency-urgency, perineal pain, and symptomatic UTI.   
 
Based on these results, the FDA indicates that “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 benign prostatic hyperplasia (BPH) and after initial post-treatment catheterization.”  
 
The FDA review also indicated that a number of other minimally invasive treatments for BPH that use different types of energy produce the same post-treatment necrotic process and temporary edema causing lower urinary tract symptoms as does TUMT.  They therefore concluded that the results of the current trial using TUMT would be applicable in patients who had received other types of minimally invasive treatments of BPH.
 
The FDA website indicates that quality of life measures are one of the secondary endpoints, although information on these measures is not provided.
 
2009 Update
A search of the MEDLINE database was performed through June 2009.
 
Dineen et al conducted a randomized study to evaluate the ability of a temporary prostatic stent (Spanner [Sp]) to manage voiding symptoms, irritative symptoms, and bother after transurethral microwave thermotherapy (TUMT) (Dineen, 2008).  Patients were randomized to the Sp or standard of care 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 shows 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 can occur 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.
 
Kijvikai et al 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 (Kijvikai, 2006).  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, and 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.
 
Vanderbrink et al conclude that “….a major disadvantage of temporary prostatic stents is that they have a small lumen that can result in an urinary retention secondary to clot–induced impairment of catheter patency, when placed in the immediate post-TUMT treatment” (Vanderbrink, 2007).
 
The American Urological Association guideline for the management of BPH includes the following statement regarding stents: “Because stents are associated with significant complications, such as encrustation, infection and chronic pain, their placement should be considered only in high-risk patients, especially those with urinary retention.” No specific language for temporary stents is included in the guideline.
 
Summary
Data are inconclusive regarding the role of temporary prostatic stents for prostatic obstruction conditions. This procedure has not been shown to improve net health outcome.  The policy statement remains unchanged.
 
2012 Update
A search of the MEDLINE database was conducted through August 2012.  There was no new information identified that would prompt a change in the coverage statement.
 
2013 Update
A literature search conducted using the MEDLINE database did not reveal any new information that would prompt a change in the coverage statement. A search of the clinicaltrials.gov website did not reveal any ongoing controlled trials located in the US assessing the clinical utility of the use of prostatic stents. The policy statement is unchanged.
  
 
2014 Update
 
A literature search conducted through August 2014 did not reveal any new information that would prompt a change in the coverage statement
 
2017 Update
A literature search conducted through August 2017 did not reveal any new published results of  randomized controlled trials that would prompt a change in the coverage statement.
 
2018 Update
A literature search was conducted through August 2018.  There was no new information identified that would prompt a change in the coverage statement.  

CPT/HCPCS:
53855Insertion of a temporary prostatic urethral stent, including urethral measurement

References: American Urological Association.(2009) Guideline on the management of benign prostatic hyperplasia. Available at: http://www.auanet.org/content/guidelines-and-quality-care/clinical-guidelines.cfm?sub=bph.

Corica AP, Larson BT, et al.(2004) A novel temporary prostatic stent for the relief of prostatic urethral obstruction. BJU Int 2004; 93:346-48.

Dineen MK, Shore ND, Lumerman JH et al.(2008) 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.

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

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

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

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


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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