Author's Accepted Manuscript

Improving Male Sling Selectivity and Outcomes‐‐ A Potential Role for Physical
Demonstration of Stress Urinary Incontinence Severity?

Boyd R. Viers, Maia E. VanDyke, Travis J. Pagliara, Nabeel A. Shakir, Jeremy M.

Scott, Allen F. Morey

PII: S2352-0779(17)30237-6
DOI: 10.1016/j.urpr.2017.10.002
Reference: URPR 324

To appear in: Urology Practice

Accepted Date: 6 October 2017

Please cite this article as: Viers BR, VanDyke ME, Pagliara TJ, Shakir NA, Scott JM, Morey AF,
Improving Male Sling Selectivity and Outcomes‐‐ A Potential Role for Physical Demonstration of Stress
Urinary Incontinence Severity?, Urology Practice (2017), doi: 10.1016/j.urpr.2017.10.002.

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 ACCEPTED MANUSCRIPT

IMPROVING MALE SLING SELECTIVITY AND OUTCOMES--

A POTENTIAL ROLE FOR PHYSICAL DEMONSTRATION OF STRESS URINARY

INCONTINENCE SEVERITY?

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Boyd R. Viers, Maia E. VanDyke, Travis J. Pagliara, Nabeel A. Shakir,

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Jeremy M. Scott, and Allen F. Morey*

Department of Urology

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University of Texas Southwestern Medical Center, Dallas, TX

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Keywords: male stress urinary incontinence, transobturator sling, Advance, artificial
urinary sphincter, standing cough testAN
Abstract word count: 240
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Manuscript word count: 2487

Figures: 2
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Tables: 3
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Supplemental: 1
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Address for correspondence:

Allen Morey, MD
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Department of Urology, University of Texas Southwestern Medical Center

5323 Harry Hines Blvd.
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Dallas, TX 75390-9110
Phone: 214-648-0202
Fax: 214-648-8786
Email: [email protected]

Disclosure: Dr. Allen Morey receives honoraria for being a guest lecturer/ meeting
participant for Boston Scientific and Coloplast Corp.
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ABSTRACT

INTRODUCTION:

We reviewed our 9-year experience with male AdVance sling cases to determine

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clinical features associated with treatment success and refine procedure selectivity. We

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hypothesized that preoperative physical demonstration of stress urinary incontinence

(SUI) by standing cough test (SCT) improves patient selection for male sling surgery.

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METHODS:

Retrospective review of primary AdVance sling surgeries between 2008-2016 was

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performed. Patients without SCT were excluded. Success was defined as ≤1 PPD
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postoperatively and no further intervention. SCT was performed during preoperative

consultation and objectively graded using the Male Stress Incontinence Grading Scale
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(MSIGS).
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RESULTS:
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Of the 203 male sling patients, 80 (39%) failed during a median follow-up of 63.5

months. From 2008-2016, the proportion of AdVance slings performed as a surgical

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treatment modality for SUI declined from 66% to 13%. Increasing selectivity correlated

with greater treatment success. Success was greater among men using ≤2 PPD
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preoperatively (77% vs 36%; p<0.0001), having physical findings of mild SUI (MSIGS
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grade 0-2 on SCT; 67% vs 26%; p<0.0001), without history of radiation (64% vs 41%;

p=0.02). In combination, non-irradiated men with mild SUI and favorable SCT were

“ideal patients” having an 81% success rate. Incremental increases in PPD usage (OR
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1.8 per pad; p<0.0001) and MSIGS grade (OR 1.7 per grade; p=0.005) were

independently associated with treatment failure.

CONCLUSIONS:

Increasing selectivity has improved sling outcomes for men with SUI. Ideal sling

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patients are non-irradiated and have both history and physical findings suggestive of

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mild SUI.

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INTRODUCTION

Although urinary control improves up to 12 months following prostatectomy1,

persistent bothersome stress urinary incontinence (SUI) occurs in up to 33% of men1-3

and is associated with a significant decrease in quality of life.4 While the AUS remains

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the gold standard for men with moderate to severe SUI, it requires manual dexterity and

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carries the risk of infection, cuff erosion, and mechanical failure. 5, 6 Alternatively, the

male transobturator sling has demonstrated durable treatment outcomes in appropriate

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patients. 7-15 Many men prefer a sling over an AUS since it avoids the need for pump

manipulation and allows for immediate spontaneous voiding.2

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Because clinical definition of the “ideal” sling candidate remains unknown,
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affected patients may often be susceptible to surgical treatment delays of many years.16

Although many men with mild SUI are specifically referred for sling consideration,
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adverse prognosticators such as radiation13, 17 and higher degrees of measurable SUI
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are important considerations. 8-12 In an effort to facilitate treatment selection in a single

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office visit, we have emphasized the objective, physical demonstration of SUI with a

standing cough test (SCT) and graded SUI severity using the Male Stress Incontinence
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Grading Scale (MSIGS)16 during initial consultation in lieu of more elaborate testing.

We hypothesized that “ideal” treatment candidates would have no history of radiation

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and both history and physical findings suggestive of mild SUI. We reviewed our 9-year
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experience with AdVance male sling surgery to determine whether incorporation of the

SCT into existing diagnostic strategies may enhance sling selectivity and treatment

outcomes.
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MATERIALS & METHODS

After Institutional Review Board approval, we retrospectively reviewed all men

undergoing first-time AdVance (American Medical Systems, Minnetonka, MN) male

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sling placement for SUI with at least 6 months of follow-up between 2008–2016. During

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the study timeframe, a total of 608 primary anti-incontinence procedures were

performed (219 Advance slings and 389 AUS). Men with previous anti-incontinence

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surgery and those without preoperative SCT documentation were excluded. SUI

etiology included: 164 radical prostatectomy, 22 radical prostatectomy + radiation, 7

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radiation, and 10 transurethral endoscopic procedures. Advance sling procedures were
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performed by a single-surgeon through a standardized midline perineal technique which

remained constant over the study interval.

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SCT was routinely performed in order to physically demonstrate and document
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the degree of SUI. Verbal confirmation was obtained that patients had not voided for at
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least 60 minutes before examination. During a series of 4 forceful coughs by the

patient, the examiner evaluated the urethral meatus to objectively quantify urine
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leakage. Towels were held several inches from the meatus during coughs to collect

urinary leakage. Degree of SUI was graded during initial office consultation by the
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examiner according to the standardized Male Stress Incontinence Grading Scale (Table
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1).16 During the first 5-years of the study period, SCT findings were recorded without

strictly influencing procedure selection. During the last 4 years of the study period, SCT

findings were stratified into favorable (MSIGS grade 0-2) and unfavorable (MSIGS

grade 3-4) and used as an additional major criterion to guide eligibility for sling surgery.
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In general, preoperative cystoscopy was only performed in those with clinical symptoms

concerning for urinary obstruction (rare), but as recommended by others18 was routinely

performed intraoperatively to document improved coaptation.

Patients were evaluated via office exam at 3 months and then as determined by

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the complexity of their condition. Patient-reported outcome measures included the

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Patient Global Index of Improvement (PGI-I) score19 and overall percentage of

improvement. Details regarding sling success were obtained from last office

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examination, any subsequent operative report, and written and/or telephone

correspondence. Complications were characterized by the Clavien-Dindo classification

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system. Primary treatment failure was defined as >1 PPD incontinence post-operatively
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or subsequent anti-incontinence procedure: AUS, repeat sling, or injection of urethral

bulking agents.
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Continuous variables were evaluated using nonparametric Wilcoxon rank-sum
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test; and categorical variables were assessed with Fischer’s exact test. Forward
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stepwise logistic regression models were used to identify variables associated with sling

failure and AUCs for each model were calculated. P<0.05 was considered statistically
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significant. Statistical analyses were performed using the SAS software package (SAS

Institute, Cary, NC).

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RESULTS

Among 203 men who underwent first-time AdVance sling placement, 123 (61%)

achieved durable primary treatment success with a median follow-up of 63.5 months

(IQR 38.9-94.3). Treatment delay between prostate cancer therapy and sling surgery

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was 33.6 months (IQR 20.4-82.8). Following sling surgery, the median overall patient

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reported percent improvement in urinary control was 90% (IQR 70-100). Of 50 patients

with PGI-I data, 74% indicated that their condition was “very much” or “much” better. A

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total of 23 complications occurred in 20 patients (10%) within 30 days of surgery

including 3 Clavien grade I, 19 grade II, and 1 grade IIIb. The most common

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complication was acute post-operative retention (N=13, 6%). No patient required sling
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removal for infection within 30 days of surgery.
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Transobturator Sling Success and Failures
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From 2008 to 2016, the proportion of male transobturator slings performed as a

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surgical treatment modality for SUI at our institution declined from 66% to 13% (Figure

1). This coincided with a lower preoperative PPD usage (p=0.03) and proportion of men
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with prior radiation (p=0.08). During this same timeframe, increasing sling selectivity

correlated with greater treatment success rates of 45% vs 85%.

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The median time to treatment failure was 8.7 months (IQR 2.2-39.0). Of these
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80 patients with unsatisfactory sling outcomes, 39 (49%) went on to further treatment,

with 30 (38%) undergoing AUS surgery at a median 16 months (IQR 7.4-32.3), 6 (8%)

sling replacement, 3 of which achieved continence, and 3 (4%) urethral bulking agents

despite using ≤1 PPD. AdVance sling failure was associated with a history of radiation
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(21% vs 10%; p=0.02), greater preoperative PPD usage (median 3 PPD vs. 1.5 PPD;

p<0.001), and increasing SCT MSIGS grade (p<0.0001) (Table 2). Patient reported

median percent improvement (50% vs 95%; p<0.0001) and the proportion of

satisfactory PGI-I responses (very much or much better) was lower among men defined

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as treatment failure (35% vs 94%; p=0.0003). All men using ≤1 ppd preoperatively with

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primary treatment success (42 of 50) reported >50% improvement in urine leakage.

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The “Ideal” Patient: Predictors of Advance Sling Success

An unfavorable SCT (MSIGS grade 3-4) correlated strongly with greater

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preoperative PPD usage (median 4 vs 2; p<0.0001) and the proportion of men using >2
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PPD (79% vs. 35%; p<0.0001) compared to men with favorable SCT (MSIGS grade 0-

2). There was a trend in greater incidence of radiation among those with unfavorable
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SCT (23% vs 13%; p=0.1). Patients with unfavorable SCT were also more likely to
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have a history of bladder neck contracture treatment (29% vs. 7%, p<0.0001), prior
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urethroplasty (3% vs. 0%, p=0.03), and were less likely to have a history of radical

prostatectomy (74% vs 94%; p=0.0003). SCT findings were not associated with age,
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BMI, or increasing time from prostate cancer treatment (Supplemental Table 1).

Advance sling treatment success was greater among men without prior radiation
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(64% vs 41%; p=0.02), and also in those who used ≤2 PPD (p<0.0001) or who had
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MSIGS grade 0-2 incontinence on SCT (p<0.0001) (Figure 2a-b). On multivariable

analysis (Table 3), an incremental increase in PPD usage (OR 1.8 per pad; p<0.0001)

and MSIGS grade (OR 1.7 per grade; p=0.005) were independently associated with

treatment failure, while radiation trended towards clinical significance. A model of PPD +
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radiation had an AUC 0.76. The use of all three in the model significantly increased the

ability to detect sling failure (MSIGS, AUC 0.71; radiation + MSIGS, AUC 0.72; MSIGS

+ radiation + PPD, AUC 0.79; p=0.003).

When evaluating the predictive utility of these clinical features stratified by both

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favorable and unfavorable PPD (≤2 vs >2) and MSIGS (grade 0-2 vs 3-4), treatment

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success was significantly greater among those with favorable PPD usage (78% vs 36%;

p<0.0001) and MSIGS grades (68% vs 26%; p<0.0001). On multivariable analysis,

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both unfavorable PPD (OR 4.6; p<0.0001) and MSIGS grade (OR 4.0; p=0.002)

remained independently associated with treatment failure. In combination, non-radiated

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men with history (PPD usage ≤2) and physical findings suggestive of mild SUI
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(favorable SCT, MSIGS grade 0-2) had an 81% success rate, constituting what we

believe represents the “ideal” sling candidate. The success rate of non-radiated and ≤2
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PPD alone was 78%. After excluding men with prior radiation, the success rate of those
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with both unfavorable SCT and PPD dropped to 41%.

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DISCUSSION

This large male transobturator sling series is novel in its analysis of the association

between increasing patient selectivity and improvement of treatment outcomes over

nearly a decade of clinical practice. The SCT appears to be a useful confirmatory

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clinical tool for the evaluation of male SUI when combined with PPD usage and

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radiation history. Only one-quarter of men with unfavorable SCT on pretreatment

clinical exam experienced treatment success, and each incremental increase in SCT

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MSIGS grade was independently associated with a 1.7-fold increased risk of treatment

failure. Accordingly, we have implemented this practical algorithm incorporating the SCT

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into our clinical practice and believe that over time it has simplified patient selection and

improved sling outcomes.

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Physical exam is underemphasized in the clinical evaluation of male SUI.
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Contemporary diagnostic strategies often rely on varying combinations of clinical
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history, PPD usage, pad weights, cystoscopy findings, and urodynamics without any
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standardized consensus on what provides the greatest value.20 The SCT was initially

proposed >20 years ago to determine if a single versus tandem cuff should be
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implanted at time of AUS surgery;21 however, precise recommendations on how to

incorporate exam findings into male surgical management strategies are lacking.22, 23
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This is different from female SUI where physical demonstration of urine leakage with
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Valsava is a conerstone of surgical decision making.

Although previous studies incorporating full urodynamic patient assessments have

used variable criteria such as PGI-I or degree of subjective improvement to define sling

outcomes24, our outcomes in the latter half of our series appear to be similar to
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most.8,12,13, 14
In our series, we defined successful sling surgery as ≤1 PPD without

further incontinence intervention because men who wear ≤1 PPD are generally satisfied

with their urinary control.4 Our definition is more stringent than other reports, capturing

those with satisfactory post-sling urinary function and those who may pursue additional

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incontinence therapies despite a significant reduction in leakage, even among men

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using ≤ 1 PPD.

Endoscopic characterization of urinary sphincter function has been proposed as a

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valuable preoperative tool for male SUI stratification.7, 11, 12, 15 Incomplete closure of the

residual urinary sphincter (OR 29.0) and absence of elongation of the coaptive zone

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(OR 26.9) during the cystoscopic “repositioning test” have been strongly associated
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with treatment failure.15 On evaluation of the “repositioning test” alone, the success rate

of those with a positive response was 83% versus only 25% in those with a negative
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test7, results that are remarkably similar to our findings. Others advocating exclusion of
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any patient without satisfactory residual sphincter function on preoperative endoscopy

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found only 53% achieved satisfactory urinary control (≤1 PPD).11

We have reserved preoperative endoscopy for only those men where there is a
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concern for urinary obstruction, since this has proven to be extremely rare in among the

mild SUI population. In our tertiary practice, performing routine cystoscopic evaluations
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during initial consultation is often difficult and associated with undue treatment delay. It
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is our belief that the SCT exam provides an efficient, objective surrogate which gives a

functional evaluation of residual urinary sphincter function at the time of initial office

consultation. In the absence of previous perineal surgery or radiation therapy where

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peri-urethral scar limits urethral mobility, the SCT seems to obviate the need for the

“repositioning test”.

Undoubtedly, the degree of measurable SUI remains one of the most important

predictors of male sling outcomes. Even in men using up to 4 PPD, Rehder et al

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reported “cure” rates of 58.6%.11 In combination with other inclusion criteria, Sturm et al

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recognized <4 PPD as an optimal cutpoint to define “ideal” sling candidates.12 We

prefer AUS over sling implantation in men using >2 PPD as we noted success rates of

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only 36% relative to a more favorable 77% among those using ≤2 PPD.

While pad weights have been advocated as a precise method to quantify degree of

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SUI, with sling thresholds of 200-400 gm on 24 hour pad testing,8-10, 12 Nitti et al have
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called into question its routine use and demonstrated excellent correlation between

perceived pad use and actual urine loss.25 We have previously established a similar
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strong correlation between SCT results and perceived pad use16, and thus have not
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routinely used pad weights in our clinical decision process.

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Although up to 50% of men undergoing urodynamic evaluation for SUI demonstrate

abnormal findings such as urgency incontinence26, these findings do not correlate with
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poor outcomes following anti-incontinence surgery.27,28 Weak correlations have further

been noted between abdominal leak point pressures and degree of male SUI (r=0.19).29
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Some major referral centers have thus recently abandoned the routine use of
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urodynamic evaluation for male SUI.30

The SCT appears to be an independent, objective, and confirmatory measure of SUI

severity and treatment success. MSIGS grade demonstrates a strong correlation with

preoperative PPD (r=0.74). We propose that further invasive studies aside from the
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immediate physical demonstration of SUI in most cases may be unnecessary and may

delay definitive treatment. Room for improvement is clearly indicated since prior reports

have shown an average treatment delay of nearly 6 years among men with SUI after

prostatectomy.16

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This 9-year single-surgeon retrospective experience has several limitations. While

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we attribute greater sling success to refinements in patient selection, increasing surgical

experience is potential component of reproducible and favorable outcomes. While we

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require that patients refrain from voiding for at least 1 hour prior to SCT, it is

conceivable that variable bladder volumes may influence the degree of demonstrable

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SUI at any point in time. Ultrasound bladder volumes in these men are not routinely
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obtained prior to SCT since we have found them to be unhelpful, with volumes in the

30-100cc range.
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It remains unclear how the SCT correlates with or reduces associated costs
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compared with centers routinely obtaining pad weights, preoperative cystoscopy, or

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multi-channel urodynamics--although we suspect cost savings are likely significant, they

are beyond the scope of this analysis. Although interobserver reliability for the MSIGS
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grading system has not been formally established, we have found the physical

demonstration of SUI by the SCT to be reliable. An ideal evaluation of sling outcomes

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would prospectively capture patient reported outcomes in combination with objective

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measures of residual urinary leakage to define treatment success. Nevertheless, this

simple office-based incontinence grading strategy may enable health care providers to

identify and refer men those men with bothersome SUI who want treatment, by
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functioning as a conformational test, thereby avoiding unnecessary testing and

treatment delay.

CONCLUSION

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Increasing selectivity resulted in better transobturator sling outcomes for men

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with SUI. The vast majority of non-radiated men with history (PPD usage ≤2) and

physical findings (favorable SCT, MSIGS grade 0-2) of mild SUI can be expected to

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achieve excellent results following sling surgery.

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FIGURE LEGENDS:

Figure 1. Proportion and success of male slings performed per year for male SUI
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Figure 2. Success of male transobturator sling surgery stratified by degree of SUI (a)
and SCT (b)
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Bauer, R. M., Gozzi, C., Roosen, A. et al.: Impact of the 'repositioning test' on
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Table 1. Male Stress Incontinence Grading Scale (MSIGS)

Grade Definition
0 Leakage reported on history but not demonstrable on exam
1 Delayed drops only
2 Early drops, no stream

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3 Drops initially, delayed stream
4 Early and persistent stream

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Table 2. Patient characteristics stratified by sling success

Primary Failure Success p-Value

(N=80) (N=123)

Baseline Characteristics
Median Age (IQR) 67.6 (62.6-73.3) 66.5 (62.5-71.3) 0.43

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Median BMI (IQR) 27.4 (25.2-30.8) 27.6 (24.6-29.9) 0.50
Comorbidities, no. (%)
Hypertension 42 (53) 62 (50) 0.77

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Diabetes 14 (18) 19 (15) 0.70
Smoker 42 (53) 62 (50) 0.77
Urologic History, no. (%)

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XRT 17 (21) 12 (10) 0.02
ADT 4 (5) 4 (3) 0.53
ED 57 (71) 90 (73) 0.76
NGB 0 (0) 2 (2) 0.25
Prior BNC 10 (13) 11 (9) 0.42

U
Prior Urethroplasty 1 (1) 0 (0) 0.21
Prior Sling 2 (3) 3 (2) 0.98
Prior IPP
Concurrently Placed IPP
Radical Prostatectomy
AN 4 (5)
21 (26)
70 (88)
5 (4)
37 (30)
114 (93)
0.75
0.55
0.22
Median Months Since CaP Treatment (IQR) 29.3 (17.2-83.3) 34.07 (20.3-80.5) 0.38
M
Standing Cough Test MSIGS grade, no. (%) <0.0001
Grade 0 7 (9) 26 (21)
D

Grade 1 8 (10) 33 (27)

Grade 2 39 (49) 55 (45)
Grade 3 9 (11) 8 (7)
TE

Grade 4 17 (21) 1 (1)

Standing Cough Test Classification, no. (%) <0.0001
Favorable (MSIGS 0-2) 54 (68) 114 (93)
Unfavorable (MSIGS 3 or 4) 26 (33) 9 (7)
EP

Baseline PPD
Median PPD (IQR) 3 (2-4) 1.5 (1-2.5) <0.0001
PPD >2, no. (%) 54 (68) 31 (25) <0.0001
Interquartile range, IQR; body mass index, BMI; radiation therapy, XRT; androgen deprivation treatment, ADT; erectile
C

dysfunction, ED; neurogenic bladder, NGB; bladder neck contracture, BNC; prostate cancer, CaP; Male Stress Incontinence
Grading Scale, MSIGS; standing cough test, SCT; pads-per-day, PPD.
AC
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Table 3. Clinical features associated with male transobturator sling failure:

multivariable analysis

PT
RI
U SC
AN
M
D
TE
C EP
AC
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PT
RI
U SC
AN
M
D
TE
EP
C
AC
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Figure 2. Success of male transobturator sling surgery stratified by degree of SUI

(a) and SCT (b)

a.)

100

PT
% Sling Treatment Success

90 84
80 73

RI
70
60

SC
50 45
40 33

U
30 22
20
10
AN
0
M
0 to 1 1 to 2 2 to 3 3 to 4 >4
Preoperative Pad Per Day Usage
D
TE

b.)
EP

100
% Sling Treatment Success

90 80
79
80
C

70
AC

59
60
50 47
40
30
20
10 6
0
0 1 2 3 4
Preoperative MSIGS Grade
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Key of Definitions of Abbreviations:

• Stress urinary incontinence (SUI)

• Standing cough test (SCT)
• Male Stress Incontinence Grading Scale (MSIGS)

PT
• Pad per day (PPD)
• Artificial Urinary Sphincter (AUS)
• Patient Global Index of Improvement (PGI-I)

RI
U SC
AN
M
D
TE
C EP
AC