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The Spanner®

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Improving Clinical Outcomes.
  • Temporarily de-obstruct the prostatic urethra
  • Reduce PVR
  • Improve voiding symptoms
  • Natural filling and emptying of bladder

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


How It Works




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.



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.



An Introduction to The Spanner

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 to the left.


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 coudé-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.

ContraindicationsCollapse
FDA Labeling CE Labeling
Positive urine culture or active urinary tract infection Prostate medial lobe enlargement
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 Positive urine culture or active urinary tract infection
Surgery altering the normal uro-genital anatomy or abnormal urethral anatomy that affects the function of the lower urinary tract History of urinary tract disease including urethral stricture, bladder neck contracture, bladder or kidney stones, other significant urological condition or abnormal urethral anatomy
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) Prior pelvic irradiation therapy
Prostatic urethra length > 6.6 cm or < 2.5 cm

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 CE Labeling
Temporary use (up to 30 days) following minimally invasive BPH treatment and after post-treatment catheterization(3, 5, 6, 7, 9) 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(6, 8, 9)
Pre-treatment / Patients diagnosed with BOO(2)
Unfit for Surgery(4)
Following minimally invasive treatment of localized prostate cancer (brachytherapy, cryotherapy)(6, 7, 8)
Chronic Catheterization (Foley / Superpubic)(2, 6)
Acute Urinary Retention / Failed Voiding Trial(6)
Prostatic Stenosis / Bladder Neck Contracture(6, 7)
Postoperative retention, non-urology surgery(6)

Instructions For Use

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 2013[AW1] 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 2014 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:


Tel:   1-866-850-7607 or 1-218-338-6700
Fax:   1-218-338-6710
Email:   

Technical Literature

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.

Peer Review Publications

ABSTRACT

Purpose

Assessment of the Spanner™, a new temporary urethral stent to relieve bladder outflow obstruction and urinary symptoms after brachytherapy.


Methods and Materials

Five patients with unusually severe urinary morbidity after 125I brachytherapy were recruited. The mean time after implant was 40 days (range 25–90). Spanner™ intraprostatic stents were introduced using topical anesthetic without complication.

Results

All patients were able to void spontaneously with no post-void residual volume of urine. The flow rates increased in all cases (p=0.03) and the International Prostate Symptom Scores were significantly improved after stent insertion in all patients (p=0.03). All patients experienced some degree of pain or dysuria during stent use.

Conclusions

Bladder outflow obstruction was effectively treated with the Spanner™ intraprostatic stent, however pain limited the use of the device in the early post-brachytherapy patient group. Pharmacotherapy, stent design modification, or smaller stent diameter may increase the utility of stents after brachytherapy.
ABSTRACT

Objectives

To determine the effect of a novel temporary prostatic stent (The SpannerTM, AbbeyMoor Medical, Inc., Minnesota, USA) on variables of voiding function and quality of life among patients with prostatic urethral obstruction.


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 (VV), 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 VVs 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.

Conclusions

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.
ABSTRACT

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.


Materials and 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.

Conclusions

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.
ABSTRACT

Objectives

Prostatic stents offer a third clinical option for patients with bladder-outlet obstruction who are unfit for surgical relief and wish to avoid long-term catheterization. We report our experience with the Abbey-Moor Spanner™ temporary prostatic stent in patients with acute and chronic symptoms of bladder-outlet obstruction secondary to benign or malignant disease who were unfit for surgery because of age or cardiorespiratory disease.


Patients and Methods

A series of 43 consecutive patients stented March 2004 through November 2005 were reviewed retrospectively. Stents were removed and replaced every 3 months if tolerated.

Results

More than half of the patients (63%) had an unsatisfactory outcome, namely, immediate or delayed retention or elective removal because of unbearable symptoms. The remaining 37% of patients had a satisfactory outcome and either continue to have the stent in situ after a mean of five changes or are stent free after a successful voiding trial.

Conclusions

Only 21% of the patients in whom stenting was indicated continued to have a stent in situ at the end of the study. We suggest that in such patients, a temporary stent such as the AbbeyMoor Spanner should be used for only 3 months as a trial of stenting followed by a trial of stent-free voiding, with the patient converted to permanent prostatic stenting if voiding is unsuccessful.
ABSTRACT

Objectives

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).

Conclusions

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.
Summary
The authors describe their experience with the Spanner as a management option for a diverse patient population of 206 men suffering from BOO. Their patient experience includes:


Unfit for BPH surgery

We have found the temporary stent to perform well in this population; however, while CE-mark approval permits its use in patients for up to 90 days, FDA labeling restricts stent placement to 30 days.


After minimally invasive surgery for BPH

In our clinical experience, stent use markedly improves quality of life in patients who undergo minimally invasive BPH treatments by decreasing the need for indwelling catheterization and leg bag usage.


After minimally invasive therapy for cancer

In our clinical observations, these patients realize the stent’s benefit of improved quality of life similar to that of post-TUMT patients.


Protracted catheter wear

These patients, more than any other, expressed their appreciation for a new-found ability to void volitionally and improved quality of life.


LUTS of unknown etiology

Temporary stenting allows the urologist and patient to evaluate objective voiding parameters and patient-perceived LUTS.
CONCLUSION
In conclusion, the Spanner prostatic urethral stent is a new device that benefits the urologic patient with poor urinary stream and/or urinary retention due to a variety of conditions. It is much more comfortable than having to wear either a suprapubic or indwelling urethral catheter with a drainage bag, and certainly is more convenient than having to intermittently catheterize oneself. The Spanner is easily placed and removed in the office. To this author, the utility and ease of use make the Spanner the “Swiss Army knife” of urologic outlet obstruction. Currently, no other such device with these specific characteristics and advantages is available in the world. Furthermore, this device is FDA approved and currently available and covered under Medicare.
ABSTRACT

Objectives

To evaluate the usefulness of a temporary prostatic urethral stent to determine which complex surgical patients would benefit from definitive surgical management of their benign prostatic hyperplasia


Methods

We retrospectively analyzed our benign prostatic hyperplasia database and identified all patients that received at least one temporary prostatic urethral stent between April 2008 and December 2010.

Results

Forty Spanner stents were placed in 20 patients. Mean age was 78.1 years and prostate size was 62.1 cm3. Urinary retention was present in 60% (12/20) of patients. No statistically significant changes in mean maximal flow rate, average flow rate, and post void residual was noted. Seven patients (35%) did well with the stent and progressed to definitive surgical management whereas 10% of the cohort (2/20) leaked urine with the stent in place and subsequently went back to catheter management. Another 30% (6/20) were unable to tolerate the stent while 1 patient passed away unrelated to the stent.

Conclusions

The use of the temporary prostatic urethral stent provided a good provocative test that enabled patients to experience what their voiding status would be if they were to undergo definitive surgical management.
SUMMARY
In the last few years we have been using Spanner™ as a diagnostic tool in patients with urinary retention. Patients with urinary retention who also have detrusor hypo-contractility are particularly challenging to manage. The conventional management is to perform a pressure-flow study or cystometric study, sometimes with cystoscophic evaluation. Detrusor hypo-contractility in the presence of bladder outlet obstruction poses a management challenge. The outcome of surgical intervention to unobstruct the bladder outlet is not predictable. The use of the temporary prostatic urethral stent, Spanner™, has helped us evaluate the detrusor function independent of bladder outlet obstruction. The experience with this approach is so encouraging that bypassing expensive urodynamic studies, and utilizing cystoscopy and Spanner™ placement instead, is under consideration. If patients with urinary retention are able to successfully empty their bladder with Spanner™, they have a very high chance of responding successfully to a debulking prostate surgery. Spanner™ malfunction and migration are, however, some issues that need improvement.
ABSTRACT

Purpose

Using Kunin and McCormick’s landmark article, the rate of bacterial colonization at 7 days for men wearing a Foley catheter is 17.4%. At 14 days, the number increases to 52.7%. We evaluate the rate of colonization of a temporary prostatic stent, an alternative to catheterization for men with obstructed prostates.

Methods

A literature review was conducted to supplement Kunin and derive valid sources of colonization rates to use as comparators to rates documented in the US IDE trial of The Spanner™ temporary stent for the prostate. Terminology was analyzed to insure comparisons were drawn only when definitions were identical to the IDE trial. Studies were further eliminated if the catheter was in place for ≤ 7 days since the stent’s indication is for longer-term use, ≤ 30 days. Since 4 meta-analyses describing trials of Foley catheters with antimicrobial coatings find no effect of the coating on colonization rate in men and insufficient evidence that systemic antibiotics impact the rate, article selection for this review was not restricted on the basis of gender or systemic antimicrobial use. Six studies identified via the meta-analyses plus Kunin were found to be applicable for comparison to the stent data. All studies utilized a standardized definition of a colony count of ≥ 105 colony-forming units per ml to refer to a positive event. All studies excluded patients with positive colonization prior to device insertion to allow direct comparison of “clean” patients across all studies. Colonization data for 676 patients wearing a Foley catheter were available from Kunin, segregated by gender and use of systemic antibiotics. Six other studies provided 779 patients. The IDE trial consisted of 100 men. Weighted means were used to account for the sample size differences among the studies.

Results

At 7 days, the stent rate of colonization is 5.4% versus Kunin 17.4% for men (p=0.015) and 14.7% for patients with antibiotics (p=0.045). At 14 days the rate is 10.5% for the stent versus Kunin 51.7% for men (p<0.001) and 51.0% for patients with antibiotics (p<0.001). Results for the remaining 6 studies are shown in Table 1.

Conclusions

Colonization rates of indwelling catheterization reported in the literature are statistically higher than the rates seen with the use of a temporary prostatic stent for up to 28 days.
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