urinary frequency, voided volume, UUI, number

degree of peripheral denervation of the pelvic

of leakage episodes, pad usage, bladder capacity,

floor striated musculature and the ability to

and quality of life. Literature supports the effi-

void spontaneously or with self-catheterization

cacy of Botox at doses of 10 U per injection site

(without electrical stimulation). Patient may

(total of 100–300 U). Procedure-related UTI are

have transient discomfort at initial skin punc-

the most common side effects. The lowest mean

ture site, but there is little pain with needle

duration of effect for Botox in patients with neu-

advancement or delayed pain. Initial results of

rogenic detrusor overactivity was 5.3 months.

posterior tibial nerve stimulation in 22 patients

Duration is typically ³6 months. Up to 16% of

with primarily urgency and UUI revealed 80%

patients with idiopathic detrusor overactivity

with at least a 75% reduction in incontinence

may need clean intermittent catheterization for

and 45% to be completely dry.

several weeks after BTX treatment.63 In a multi-

institutional, randomized,

double-blind,

pla-

Stress Urinary Incontinence

cebo-controlled clinical trial comparing 200 U

intra-detrusor BTX-A and placebo in women

with refractory idiopathic

UUI, 60%

who

The International Continence Society (ICS)

received BTX-A had a clinical response. BTX-A

defines SUI as the complaint of involuntary leak-

was effective and durable, yet 43% experienced a

age on effort or exertion, or on sneezing or

coughing3 Unlike men who develop SUI follow-

Sacral nerve stimulation (SNS) or neuromod-

ing an iatrogenic cause, SUI in women is an

ulation has been approved by the FDA for the

indolent process and may take much longer to

treatment of UUI since 1997. The mechanism of

present for management.

action remains unclear, yet numerous studies

note long-term success and safety. SNS is usually

Male SUI Therapies

performed in two stages: first a temporary or

permanent external lead is placed into the S3

Following prostate surgery or radiation, men are

foramen for external stimulation; and second a

subcutaneous impulse pulse generator is

encouraged to attempt active conservative man-

implanted. A prospective, multicenter 5-year

agement with fluid restriction, medication man-

trial of 163 patients (87% female) was performed

agement(forurgencyandUUIrelatedsymptoms),

to assess the efficacy and safety of SNS. They

and pelvic floor exercises. Parekh et al. reported

reported a significant decrease in mean leaking

on pre-op pelvic floor exercises aiding in earlier

episodes per day (9.6 ± 6 to 3.9 ± 4) and no life-

achievement of urinary continence, yet pro-

threatening or irreversible adverse events

longed conservative management has question-

occurred.65 Sutherland et al.reported on 11 years

able merit.67,68 Periurethral bulking agents are a

of experience with SNS performed in 103

minimally invasive treatment option for male

patients (87% female). Statistical significant

SUI, but have extremely low cure rates, 5–8%.69-71

improvement post implantation was noted in

Surgical intervention is indicated for treating

leaks per 24 h and pads per 24 h. There was

male SUI that is persistently bothersome despite

60.5% improvement based on quality of life.66

12 months of active conservative management.

Central sacral neuromodulation has been

The severity of incontinence and magnitude of

successful in treatment of urgency and urge

the effect on the patient’s quality of life is bal-

incontinence, yet a significant drawback is that

anced against the risks of surgery. The male sling

placement of the stimulator is invasive, there is

and artificial urinary sphincter (AUS) are the two

moderate complication rate, and up to 50%

most common surgical procedures for the man-

require reoperation. Thus, various approaches

agement of PPI.This choice is based on the sever-

to minimally invasive, peripheral transcutane-

ity of leakage, comfort with implantation and

ous nerve stimulation (PTNS) have been tested,

manipulation of an artificial device,patient phys-

including stimulation of the posterior tibial

ical limitations, and need for continuous inter-

nerve and pudendal (dorsal penile/ clitoral)

mittent catheterization.There are no prospective,

nerves. PTNS like SNS requires a cooperative

randomized comparisons between these two

patient with a morphologically intact urinary

modalities, yet both techniques have been stud-

tract, normal sacral spinal reflex center, limited

ied and reported on extensively.72

444

PRaCtiCal URology: ESSEntial PRinCiPlES and PRaCtiCE

The AUS was first introduced in 1973 and has

or much improved. Rajpurkar et al. reported sat-

undergone numerous redesigns to the present

isfaction rates of 70% and 74% improvement in

date. It circumferentially occludes the urethra

leakage at a median of 24 months.80 There are no

(usually bulbar urethra) with continuous com-

reported cases of prolonged urinary retention

pression,controlled by an intra-abdominal pres-

or new onset UUI in the literature following a

sure regulating balloon (IPG) (with 22 cm3 of

male sling.70 The infection and erosion rates,

normo-osmotic mixture at 61–70 cm water pres-

2.1% and 4.2% respectively,79 are much lower

sure). During voiding, activation of a scrotal

than seen following AUS placement. There is

pump diverts the compressive fluid from the

limited published information on a new tran-

cuff to the balloon reservoir, relieving the occlu-

sobturator male sling. Thus far, reported data

sive effects of the cuff on the urethra. Primary

indicates a 40% success rate 6 weeks post-op.81

and double-cuff techniques have been utilized,

The AUS and male sling are both contraindi-

though double cuffs are associated with a higher

cated for patients requiring transurethral sur-

rate of erosion. Historically abdominal and

gery, due to higher risk of erosion and infection.

perineal incisions are made for placement of the

Unlike the AUS, a patient’s pre-op detrusor con-

IPG, cuff, and pump. There has also been success

tractility must be considered prior to male sling

with single scrotal incision approach for place-

surgery. Detrusor hypocontractility is a con-

ment of all three parts.73-77 In cases of an AUS

traindication for the male sling due to the risk of

revision for urethral atrophy or erosion, a

increased outlet resistance leading to upper uri-

transcorporeal approach may be used. With the

nary tract damage. In patients with detrusor

introduction of the narrow back cuff in 1987, the

hypocontractility, AUS implantation is recom-

success rates for the AUS are upwards of 90% in

mended. In patients with previous AUS or male

modern series for all levels of incontinence. The

sling surgery, primary radiation therapy, or

largest series to date, from the Mayo Clinic,

severe or total incontinence, the AUS is pre-

included 323 patients with a mean follow-up of

ferred. The male sling is preferred in patients

6 years and reported a 90% success rate. Their

with poor manual dexterity or insufficient men-

revision rate was 17% with a narrow back cuff.78

tal faculties to cycle AUS, those patients wanting

Infection and urethral erosion are often related

to spontaneously void without manipulation,

and range from 0% to 25% when reported as a

and those requiring intermittent catheteriza-

single entity. When reported separately, infec-

tion. The male sling is better selected in those

tion rates with initial AUS surgery is 0–3%, and

patients with mild SUI and good detrusor con-

as high as 10% in patients who underwent radi-

tractility due to a lower infection and revision

ation therapy or in cases of repeat AUS surgery.

rate.72

Revision rates are approximately 8% and 9% for

nonmechanical and mechanical failure and

Female SUI Therapies

15–25% for recurrent ISD (from urethral atro-

phy) at 5 years with the narrow-backed cuff.72,78

Patients and physicians can choose between

The male sling was devised in response to the

conservative, nonsurgical, pharmacological, and

risks of infection and urethral erosion associ-

surgical treatment options for female SUI.

ated with the AUS, and to allow for voiding with-

Conservative therapy is the first-line therapy,

out device manipulation. The modern male

especially when the SUI is less severe. Lifestyle

sling has gone through many versions prior

modifications such as weight loss, smoking ces-

to the commonly used transperineal bone-

sation, and fluid intake adjustments are often

anchored, minimally invasive approach. Six

initially recommended as early measures. Many

titanium bone screws suspend a piece of sili-

patients make these changes in order to cope

cone-coated polyester mesh to the medial aspect

with their condition.82 In addition, patients are

of either descending ramus, creating approxi-

encouraged to perform timed voiding,prompted

mately 60 cm of water compression on the ure-

voiding or bladder training, Kegel exercises, and

thra. Two large prospective studies reported

maintain a voiding diary. These measures ide-

success rates of 70–80%. In the first, with a

ally help increase effective bladder capacity.

median follow-up of 48 months, symptom score

Voiding logs are essential in understanding the

and pad use were significantly improved.79 Two-

patient’s fluid intake in relationship to their out-

thirds were made pad free and 80% were cured

put and the voiding interval. The log therefore

can act as a reminder to void (timed voiding)

to urination. There is a meatal plate to prevent

and also provide a schedule to increase their

migration of the device into the bladder and a

voiding interval. Fantl et al. reported a 57%

string to enhance removal. Adverse effects

reduction in incontinence episodes and a 54%

include hematuria, UTIs, and discomfort.83,85

reduction in quantity of urine loss in older

Pessaries or intravaginal support devices are

women attempting conservative measures,

often used for symptomatic prolapse, but may

which was similar in patients with UUI and

be used to treat SUI, especially in those patients

SUI.83 Pelvic floor muscle training (PFMT)

with mild to moderate anterior vaginal wall pro-

incorporates repeated high-intensity, pelvic

lapse, associated with hypermobility. Pessaries

muscle contractions of both slowand fast-

act by mechanically supporting the bladder

twitch muscle fibers. PFMT is believed to

neck.83

strengthen the pelvic floor muscles (PFM), par-

There is no globally used or widely successful

ticularly the levator ani, and enhance the ability

pharmacological treatment available for SUI,

to produce an increase in urethral resistance.

due to the large variability in success rates and

Combination therapies involving PFMT and

significant adverse effects. Pharmacologic ther-

adjuncts, such as vaginal cones, biofeedback,

apy has included: a-adrenergic agonists, imip-

and electrical stimulation, do not have addi-

ramine, duloxetine, ß-adrenergic agonists and

tional benefit, except to assist a woman to learn

antagonists, and hormonal therapy. The bladder

how to perform a correct PFM contraction.82,83

neck and urethra contain a large number of

A multicenter trial of behavioral measures,

a-adrenergic receptors that induce muscle con-

PFMT, and combination therapy was conducted

traction and increase outlet resistance. Multiple

in 204 women over 3 months. The combination

a-adrenergic agonists (phenylpropanolamine)

arm reported significantly fewer incontinence

have been tested with poor cure rates (0–14%)

episodes, better quality of life, and greater treat-

and side effects ranging from 5% to 33%.86

ment satisfaction. Yet, 3 months after comple-

Caution must be utilized in patients with hyper-

tion of the trial, there were no differences noted.

tension, cardiovascular disease, or hyperthy-

This confirms the importance of patient compli-

roidism. Phenylpropanolamine was withdrawn

ance and reinforcement in achievement of suc-

from market after an increased risk of hemor-

cess.84 Compliance is in fact the main drawback

rhagic stroke was documented. TCA antidepres-

of conservative therapy.

sants have central and peripheral anticholinergic

Nonsurgical, occlusive, or supportive devices

effects at some sites, block the active transport

are utilized in a group of women for manage-

in presynaptic nerve endings preventing

ment of SUI. There are some comfort issues

reuptake of norepinephrine and serotonin, and

related to size, suppleness of device, and patient

act as a sedative. Imipramine theoretically

willingness to manipulate their genitals to uti-

decreases bladder contractility and increases

lize these devices. Additionally, a number of the

outlet resistance.83 In an open label study of imi-

occlusive devices are single or disposable prod-

pramine, a 35% cure rate by pad test and addi-

ucts, making cost substantial. Sexual activity

tional 25% subjective improvement was

may be affected if the device needs to be removed

reported.87 TCAs are associated with dry mouth,

before or after coitus, resulting in inconvenience

constipation,retention,orthostatic hypotension,

and coital incontinence. Extra-urethral, intrau-

and falls.33

rethral and intravaginal (pessaries) supportive

Duloxetine was the first widely available phar-

devices have been used. The extra-urethral

macological treatment option licensed for the

device (Miniguard®, FemAssist®, or CapSure™)

treatment of SUI. Duloxetine is a combined

must be removed prior to voiding.While subjec-

serotonin and norepinephrine reuptake inhibi-

tive and objective (pad test) outcomes have

tor, with no affinity for neurotransmitter recep-

shown slight improvement, there is associated

tors. Duloxetine increases the concentration of

transient vulvar and lower urinary tract irrita-

both serotonin and noradrenaline in the synap-

tion, vaginal irritation, and urinary tract infec-

tic cleft in Onuf’s nucleus, which promotes

tions. Single-use, disposable intraurethral

enhanced activity of the striated urethral

devices (FemSoft®) are inserted directly into the

sphincter.83,88 Duloxetine appeared to have great

urethra, obstructing the flow of urine into the

promise on initial use, but has since shown on

proximal urethra. They must be removed prior

multiple studies to have high discontinuation

PRaCtiCal URology: ESSEntial PRinCiPlES and PRaCtiCE

rates from adverse effects. Vella et al. reported

agents: UTI, hematuria, and transient elevation

on 1-year follow-up of duloxetine treatment for

of postvoid residuals.82,83

SUI in 228 women.Only 9% of patients remained

Sling procedures can be divided into the clas-

on duloxetine for 1 year and 82% had a tension-

sic pubovaginal sling and the minimally invasive

free vaginal tape. The majority of women dis-

mid-urethral polypropylene sling. As opposed

continued use due to adverse effects (56%) or

to an urethropexy, sling surgery may not only

lack of efficacy (33%).89Adverse effects include

provide a “backboard” of support for the vesi-

nausea, fatigue, dry mouth, insomnia, and sui-

courethral junction, but also create some degree

cidal ideation or behavior in individuals under

of urethral coaptation or compression. The clas-

the age of 24 years.83

sic sling is used for women with ISD and may be

ß-adrenergic agonists (clenbuterol) may have

used as a primary option or in patients who

some efficacy through an action agonism result-

failed initial anti-incontinence surgery. Slings

ing in smooth muscle relaxation of the bladder

should be tied at the bladder neck (after passage

wall.Yasuda et al.90 reported on results of a dou-

through the endopelvic fascia and behind the

ble-blind, placebo-controlled trial with clen-

pubic bone) with minimal or no tension to pre-

buterol in 165 women in Japan and found

vent bladder outlet obstruction (Fig. 32.3).

significant improvement in frequency of incon-

Historically, autologous rectus fascia and fascia

tinence, pads per day, and overall global assess-

lata are the most commonly used sling materi-

ment of treatment. It is presently only approved

als. Other materials that are used include: vagi-

for SUI use in Japan. ß-adrenergic antagonists

nal wall, human cadaveric tissue, xenograft, and

theoretically enhance norepinephrine effects on

synthetic materials. Long-term studies note cure

a-adrenergic receptors in the urethra. Prop-

rates greater than 80% and rates of improve-

ranolol has shown some beneficial effect in

ment of greater than 90%.92,93 Autologous mate-

uncontrolled small numbers. This has not been

rials are generally associated with higher cure

reported in randomized, controlled trial.33,83

rates than cadaveric or synthetic materials.82,83

Estrogen receptors are present in the vagina,

In the mid-1990s, the TVT was introduced for

urethra, bladder, and pelvic floor, yet their role

treatment of SUI. This is a minimally invasive

remains controversial.Understanding estrogen’s

option mainly used for women with urethral

role is based on cytologic and clinical changes

hypermobility. The TVT is passed through the

observed after menopause and the high inci-

retropubic space and aims to reinforce puboure-

dence of incontinence reported by elderly, post-

thral ligaments and secure proper fixation of the

menopausal women. This literature has been

mid-urethra to the pubic bone for maintenance

reviewed extensively, and an evidence-based

of continence. Three small incisions are made

recommendation for the use of estrogens to

(two suprapubic and one on the anterior vaginal

treat SUI in women is not supported.4,33,83

wall at the mid-urethra).82 A prospective study

Manysurgicalprocedureshavebeendescribed,

comparing the TVT to the open Burch colposus-

which can be divided into three types: urethral

pension found the same effectiveness (TVT 81%

bulking agents (injectables), suburethral sling

and Burch 80%).94 Bladder perforation is the

procedures, and colposuspension. Bulking

most

agents were initially described to treat SUI

(intraoperative cystoscopy is required) occur-

caused by ISD, but have since been found to have

ring in 1 in 25 cases. Postoperatively, complica-

applicability in urethral hypermobility also.

tions

Most periurethral agents are injected in a retro-

de novo detrusor overactivity.82 The transobtu-

grade fashion under direct cystoscopic guidance

rator tape (TOT) was initially marketed to avoid

with local anesthesia. Various agents (GAX col-

the retropubic space and risk of bladder perfo-

lagen, Teflon®, silicone, fat, cartilage, Coaptite®,

ration associated with the TVT. Yet, there are

Durasphere®) have been used to increase outlet

numerous reports of bladder perforation with

resistance. Each of these agents has variable bio-

the TOT, making cystoscopy essential following

physical properties influencing tissue compati-

TOT placement. Three small incisions (two

bility,tendency for migration,density,durability,

groin incisions lateral to the inferior pubic

and safety. Success rates range from 40% to 86%

ramus and one vaginal incision in the mid-ure-

with continuous decline in efficacy over time.

thra) are made with the TOT. The complication

There is low morbidity associated with bulking

and cure rates are similar between the TOT and