The Spanner® | Healthcare Professionals

The Spanner®

The Spanner Prostatic Stent is a temporary stent inserted into the urethra at the neck of the bladder to maintain urine flow. The Spanner benefits men with bladder outlet obstruction (BOO) by reducing elevated post void residual (PVR), improving voiding symptoms, and allowing for voluntary urination. As an alternative to a Foley Catheter, it allows your patients to naturally fill and empty their bladders.

Key Benefits of The Spanner

  1. Clinically proven to accurately measure voiding pressure.
  2. Normal micturition achieved with bladder and sphincter.
  3. Simple and quick to perform.
  4. Improves urination efficiency by decreasing urine left in the bladder.
  5. Reduces rate of bacterial colonization compared to the Foley catheter.
  6. Well tolerated by patients.
  7. Improves IPSS scores.
  8. Greatly preferred by patients over catheterization.

How It Works

The Spanner® Prostatic Stent has been designed to open the prostatic urethra and allow patients to maintain urine flow and allow volitional voiding by reducing urethral resistance within the prostate. As shown in the figure to the left The Spanner has a proximal balloon that is seated in the bladder neck to properly position the stent in the prostatic urethra. The stent extends from the bladder to just above the external sphincter. Device tethers (suture material) traverse the external sphincter to allow normal sphincter function, thus providing patients the ability to volitionally void. The distal anchor of the device is positioned in the bulbar urethra, just below the sphincter, to prevent device movement and migration into the bladder.

The Spanner Placement

The Spanner is inserted and positioned tactilely using a detachable introducer (no cystoscopy required). The Spanner has been designed for administration in the office setting with use of a numbing agent for patient comfort.

The Spanner Removal

The stent is removed using the retrieval tether (retrieval suture) that provides for the deflation of the balloon and withdrawal of the stent.

For more details about The Spanner, and to view an animation showing how the stent is inserted and removed by your healthcare professional, please take a few minutes to review the video above.

How The Spanner Is Provided

The stent and introducer are provided together in a sterile package. The Spanner is currently available in 20F diameter, six sizes (4, 5, 6, 7, 8 and 9 cm) with a coude-tip. The Spanner size selection is enabled by the use of an accessory, The Surveyor™ urethral measurement device. The Surveyor is designed to assess the length of the urethra from the bladder neck to the bottom side of the external sphincter in order to select the appropriate Spanner size.

Click here for more information on The Surveyor™

Indications For Use

FDA Approved Indications for Use:

The Spanner 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.

CE Approved Indications for Use:

The Spanner is indicated for temporary use (≤90 days) in men with bladder outlet obstruction (BOO) to reduce elevated post void residual (PVR) and improve voiding symptoms.

Contraindications

FDA Labeling

Positive urine culture or active urinary tract infection.

History of symptomatic urinary tract disease such as urethral stricture, bladder stones, or other significant urological conditions (e.g. gross hematuria) that could affect the function of the stent.

Surgery altering the normal uro-genital anatomy or abnormal urethral anatomy that affects the function of the lower urinary tract.

A prostatic urethral length less than 4 cm or greater than 9 cm (combined length from the top (proximal side) of the bladder neck to the bottom (distal side) of external sphincter).

Patient Populations who may benefit from The Spanner:

There are several patient populations who may benefit from The Spanner as an alternative to a Foley catheter. These populations are listed in the table directly below. The table identifies the limitations in US labeling and provides literature citations for each of the patient populations.

A temporary prostatic stent is a versatile clinical tool. The Spanner stents the bladder neck and prostatic urethra while allowing the patient to maintain a full and normal lifestyle. Temporary stenting can be used to: (1) diagnose symptom etiology and predict treatment success, (2) reduce PVR and improve voiding symptoms in patients with bladder outlet obstruction, and (3) post-surgically to prevent the scarring that may occur at the bladder neck from obstructing the bladder outlet.

FDA Labeling

Temporary use (up to 30 days) following minimally invasive BPH treatment and after post-treatment catheterization

CE Labeling

Temporary use (up to 30 days) following minimally invasive.

BPH treatment and after post-treatment catheterization.

Temporary use (≤ 90 days) in men with bladder outlet obstruction (BOO) to reduce elevated post void residual (PVR) and improve voiding symptoms.

Differential Diagnosis of detrusor hypo-contractility.

Pre-treatment / Patients diagnosed with BOO.

Unfit for Surgery.

Following minimally invasive treatment of localized prostate cancer (brachytherapy, cryotherapy).

Chronic Catheterization (Foley / Superpubic).

Acute Urinary Retention / Failed Voiding Trial.

Prostatic Stenosis / Bladder Neck Contracture.

Postoperative retention, non-urology surgery.

Instructions For Use:

The physicians guide to inserting and removing The Spanner®.

Patient Emergency Removal Card:

The patient is provided with an emergency removal card which he is required to keep on his person at all times. It contains step by step removal instructions for healthcare professionals in the event of an emergency.

Patient Information Booklet:

An optional, informational resource which may be provided to the patient.

Coding & Reimbursement

The reimbursement information provided is gathered from third-party sources and is intended to provide general information for reference purposes only. As such, SRS Medical makes no guarantee of coverage or payment. Reimbursement policies change frequently and can vary considerably from one insurer to another. SRS Medical strongly recommends that you consult your payers for interpretation of local coverage and reimbursement policies. Every reasonable effort has been made to ensure the accuracy of this information, however, the ultimate responsibility for coding and claims submission lies with the physician, clinician, hospital or other facility.

Please refer to the 2019 CPT ® manual for specific guidance (CPT is a registered trademark of the American Medical Association).

How do I code for the insertion of The Spanner?

You should use CPT code 53855 – Insertion of a temporary prostatic urethral stent, including urethral measurement. Read more about CPT and ICD-9-CM coding for The Spanner in the 2019 Quick Code Guide provided to the right.

Can I charge for supplies used during the insertion of The Spanner?

No, the supplies are included in the procedure. The practice expense portion of the RVU includes the materials and equipment necessary to perform the procedure.

Can we bill for a separate evaluation and management service in addition to the insertion of the stent?

The physician will need to indicate that on the day of the procedure the patient’s condition required a significant, separately identifiable E/M service above and beyond the services usually associated with the procedure that was performed. This circumstance may be reported by adding the modifier -25 to the appropriate level of E/M service.

How do I code for removal of The Spanner?

If the stent is removed by pulling on the tether you should code the appropriate Evaluation & Management level. There is no specific CPT code for the removal of a temporary prostatic urethral stent done in this manner.

If a cystoscopy is required to remove The Spanner you may bill using the appropriate CPT code.

The Spanner Reimbursement Support Line provides assistance for obtaining coverage and payment of The Spanner stent for the prostate. It is staffed by highly trained reimbursement professionals who are available from 9:00-6:00 PM EST to help a urologist office staff get started down the road to successful reimbursement. A Spanner reimbursement professional will respond to all inquiries within one business day regarding any of the following areas:

  • Answer questions regarding coding, coverage, and payment.
  • Answer questions about preparing claims.
  • Resolve problem claims.
  • Appeal denied claims.

Tel: 1-866-850-7607 or 1-978-932-0350

Email: reimbursement@srsmedical.com

Technical Literature

Peer Review Publications

The Spanner® is widely written about with positive attestation in peer-reviewed clinical literature. Individual citations along with abstracts and links to the complete documents are provided below.

Using Temporary Prostatic Stents to Eliminate Bacterial Colonization in Men with Chronic Indwelling Catheters: A Pilot Study Sabharwal S, Sabharwal S. Cureus (2018).

Background

Chronic urinary catheterization is commonly associated with chronic bacterial colonization and high rates of symptomatic infection that increase morbidity and mortality. This study describes the results of replacing chronic catheters with temporary prostatic stents (TPS) to reduce bacterial colonization rates.

Methods and Materials

Twenty-two chronically catheterized adult male patients were enrolled. Upon removal, the indwelling urinary catheter (IUC) was cultured to identify the presence and type of bacterial flora. The IUC was replaced with a TPS. All patients had five consecutive TPS placed on a 30-day cycle. TPS cultures were obtained at removal of each TPS.

Results

All patients (100%) demonstrated bacterial colonization at baseline (removal of the IUC). After the third month with TPS, the colonization had fallen to 5% and remained at 5% for the final two months of TPS placement.

Conclusion

This pilot study suggests that replacing an IUC with a TPS interrupts the cycle of bacterial colonization in the urinary tract. This approach could be a strategy for eliminating multi-drug resistant organisms from the urinary tract of men with urinary retention.

 

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Infectious complications associated with the use of temporary prostatic urethral stents in patients with benign prostatic hyperplasia. Abdul-Muhsin HM, Jakob NJ, McLemore RM, McAdams SB, Humphreys MR. The Canadian Journal of Urology (2016).

Introduction

To examine the infectious outcomes after the insertion of the temporary prostatic urethral stent (TPUS) in benign prostatic hyperplasia (BPH) patients.

Methods and Materials

Between November 2007 and September 2012, ninety TPUS were used in 33 patients with BPH at our institution. All patients had negative urine cultures prior to the first stent insertion. TPUS were sent for cultures at time of removal or exchange. Stents were removed at the time of definite surgical intervention, at 4-6 weeks, or when patients elected another course of treatment. Colonization was defined as asymptomatic positive stent culture. Infection was defined as symptomatic positive stent culture requiring treatment. Infection and colonization rates are reported. Logistic regression was used to examine the predictors of infection at any point. Predictors examined were age, body mass index, history of prostate cancer, diabetes mellitus, hyperlipidemia, coronary artery disease, neurologic disorder, erectile dysfunction and the sequence of stent placement.

Results

The majority of the subjects, 72% (24/33) had 1-2 stents, 9.0% (3/33) had 3-4 stents, 6.0% (2/33) had 5-6 stents, and 12% (4/33) of patients had more than 6 stents. From the 69 available culture results, the symptomatic infection rate was 16% (11/69) (95% CI: 8.2%-26.7%). The colonization rate was 58% (40/69) (95% CI: 45.5%-69.7%). None of the predictors examined were identified as a predictor of infection. There was no colonization detected when stents were removed in the first 20 days.

Conclusion

Infection rates with TPUS in BPH patients are acceptable and early removal may prevent colonization.

 

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Treating male retention patients with temporary prostatic stent in a large urology group practice. Roach RM. Canadian Journal of Urology (2017).

Background

Men with either chronic or temporary urinary retention symptoms are common patients treated in a urology practice. Both indwelling and intermittent catheterization are widely used to treat this condition. These approaches are associated with significant complications including infection and reduced quality-of-life. Infection is a target for quality improvement and cost reduction strategies in most care settings today.

Methods

We use a temporary prostatic stent (TPS) to address these issues in our practice.

Results

In this report, we describe our approach to patient selection, sizing, placement and follow up of 214 TPS placed in 56 men with chronic or temporary urinary retention in an office setting. With the first stent placement, average indwelling time was 27 days. Thirty-two patients had multiple stents placed. Replacement was performed routinely and was generally required because underlying comorbidities precluded surgery. In these patients, an average of six stents were placed (range 2-18) with average dwell times of 31 days. Symptomatic urinary tract infections (SUTI) occurred in only 6 of 214 TPS placements (2.8%), resulting in an incident rate of 0.93 SUTI per 1,000 TPS days.

Conclusion

TPS is a safe and efficacious means of alleviating symptoms of urinary retention. TPS does not share the same infection risk profile or quality-of-life drawbacks associated with urinary catheters; this makes TPS use relevant as a urinary catheter alternative or when a urinary catheter is not recommended.

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Temporary prostatic stents as a replacement for urinary catheters following transurethral microwave thermotherapy: A retrospective review. Kessaris D, Bellas A. Cogent Medicine (2017).

Background

Benign prostatic hyperplasia (BPH) is a common cause of lower urinary tract symptoms (LUTS) in men. In our practice, we employ Transurethral Microwave Thermotherapy (TUMT) as an effective and minimally invasive means of treating BPH for patients presenting with small to moderate prostate size. TUMT utilizes the transfer of heat to necrotize prostatic tissue in the treatment zone, resulting in prostatic edema that can temporarily exacerbate symptoms during the post-procedure recovery period.

Methods

Management of post-procedure voiding symptoms often requires the use of an indwelling urinary catheter (IUC), in some cases, for an extended period. We systematically replace post-TUMT IUC with temporary prostatic stents (TPS) to alleviate voiding symptoms, reduce infection risk and improve the quality of life during recovery. The purpose of this study is to assess the clinical efficacy of TPS using The Spanner® Temporary Prostatic Stent in men with BPH, post initial catheterization following TUMT. This review documents the effects of TPS on post-void-residual (PVR), infection rate, and complication rate in 25 consecutive men treated with our TUMT/TPS protocol.

Results

Our data demonstrates that TPS had effectively reduced edema-related urethral resistance in the post-TUMT recovery period, resulting in reduced PVR and no incidence of infection.

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A novel temporary prostatic stent for the relief of prostatic urethral obstruction. Corica AP, Larson BT, Sagaz A, Corica AG, Larson TR. BJU International (2004).

Purpose

To determine the effect of a novel temporary prostatic stent on variables of voiding function and quality of life among patients with prostatic urethral obstruction.

Patients & Methods

The stent design is very similar to the proximal 4-6 cm of a Foley catheter; this includes 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. There is also a distal anchor mechanism attached by sutures, and a retrieval suture which extends to the meatus and deflates the proximal balloon when pulled. The stent was inserted under topical anaesthesia in 30 patients. The maximum flow rate (Qmax), voided volume (W), postvoid residual (PVR), the International Prostate Symptom Score (IPSS) and stent position were assessed.

Results

Stents remained in situ for a mean (range) of 57 (1-98) days. The mean overall Qmax at baseline and after insertion were 8.2 and 11.6 mL/s, representing a 42% improvement (P < 0.001); the respective mean overall Ws were similar, at 219.7 and 221.6 mL (0.9% increase, not significant) and the PVRs were 312.1 and 112.3 mL, representing a 64% decrease (P = 0.004). The overall mean IPSS declined from 22.3 before to 7.1 after insertion, representing a 68% decrease (P < 0.001). There were only minor adverse events. The stability, patency and lack of migration of the device were confirmed radiographically up to 12 weeks of use.

Conclusion

This early study shows that this temporary prostatic stent is easily inserted and removed, remains anchored in position, and significantly improves the Qmax, PVR and IPSS while preserving volitional voiding and continence.

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A temporary intraurethral prostatic stent relieves prostatic obstruction following transurethral microwave thermotherapy. Shore ND, Dineen MK, Saslawsky MJ, Lumerman JH, Corica AP. The Journal of Urology (2007).

Purpose

The Spanner, a novel prostatic stent, was evaluated for safety, efficacy and patient tolerance when used to relieve prostatic obstruction following transurethral microwave thermotherapy.

Methods

Following transurethral microwave thermotherapy and routine post-procedure Foley catheterization at 1 of 9 clinical sites 186 patients meeting study criteria were randomized to receive a Spanner (100) or the standard of care (86). Baseline evaluations included post-void residual urine, uroflowmetry, International Prostate Symptom Score and International Prostate Symptom Score quality of life question. These evaluations were repeated at visits 1, 2, 4, 5 and 8 weeks after randomization (Spanner insertion) with the addition of the Spanner satisfaction questionnaire, ease of use assessment and adverse events recording. The Spanner was removed after 4 weeks, at which time the Spanner and standard of care groups underwent cystourethroscopy.

Results

At the 1 and 2-week visits the Spanner group showed significantly greater improvements from baseline in post-void residual urine, uroflowmetry and International Prostate Symptom Score compared to the standard of care group. The Spanner group experienced significantly greater improvements in quality of life at the 5 and 8-week visits. Patient satisfaction with the Spanner exceeded 86%. Cystourethroscopy findings in the Spanner and standard of care groups were comparable and adverse events associated with previous stents were rare.

Conclusion

The Spanner is a safe, effective and well tolerated temporary stent for severe prostatic obstruction resulting from therapy induced edema after transurethral microwave thermotherapy. It may be a needed addition to the armamentarium for managing bladder outlet obstruction in a broad group of urological patients.

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Use of a Temporary Prostatic Stent After Transurethral Microwave Thermotherapy Reduced Voiding Symptoms and Bother Without Exacerbating Irritative Symptoms. Dineen MK, Shore ND, Lumerman JH, Saslawsky MJ, Corica AP. Urology (2008).

Purpose

To evaluate the ability of a temporary prostatic stent (Spanner [Sp]) to manage voiding symptoms, irritative symptoms, and bother after transurethral microwave thermotherapy (TUMT) for prostatic obstruction.

Methods

Patients were randomized to the Sp (n = 100) or standard of care (SOC, n = 86) after TUMT with 3 to 10 days of routine catheterization. We evaluated International Prostate Symptom Score (IPSS) voiding subscore, IPSS irritative subscore, voiding diary data, and Benign Prostatic Hyperplasia Impact Index (BII) 7 to 10 days before TUMT and repeated them 1, 2, 4 (stent removal), 5, and 8 weeks after stent insertion.

Results

After 1 week of stent use, the Sp group experienced significantly greater improvements in the IPSS voiding subscore (Sp = -4.9 versus SOC = -2.3, P = 0.002) and individual voiding symptoms assessed by the IPSS (intermittency, weak stream, and straining) and voiding diary data (stream strength, and strain). After 2 weeks, the Sp group showed a trend toward greater improvements in IPSS voiding (P = 0.059) and irritative (P = 0.058) subscores and reported significantly less bother (BII, Sp = -2.1 versus SOC = -1.1, P = 0.033). After stent removal, the Sp group reported significantly greater improvements in the IPSS irritative subscore (5 weeks: Sp = -4.0 versus SOC = -2.7, P = 0.029; 8 weeks: Sp = -5.0 versus SOC = -4.0, P = 0.050), individual voiding (stream strength and dysuria), and irritative (frequency and urgency) symptoms and bother (5 weeks: Sp = -4.0 versus SOC = -2.3, P = 0.002; 8 weeks: Sp = -5.0 versus SOC = -3.1, P = 0.001).

Conclusion

The Spanner, a temporary prostatic stent, improved voiding symptoms and bother without exacerbating irritative symptoms. Improvements in symptoms and bother were sustained after stent removal.

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