APP

NMES Contraindications

• Complete denervation of the pelvic floor
• Dementia
• Unstable or serious cardiac arrhythmia
• Pregnancy
• Broken/irritated peri-anal skin
• Rectal bleeding
• Active infection (e.g. UTI, vaginal)
• Unstable seizure disorder
• Swollen, painful hemorrhoids

NMES Adverse Effects

• Abdominal cramps
• Diarrhea
• Anal pain or bleeding
• Vaginal irritation, pain or bleeding

NMES Use in Specific Populations

• Stress Urinary Incontinence (SUI)
• Urgency Urinary Incontinence (UUI)
• Fecal Incontinence (FI)
• Chronic Pelvic Pain Syndrome (CPP)

91

NMES for Stress Urinary Incontinence

• NMES of the pudendal nerve

• Can cause PFM contraction through a pudendal nerve reflex loop
• Majority of urethral nerve fibers operate at high frequencies (50-100HZ)
• Causes a direct motor response to the muscle
• A reflex widespread contraction of the pelvic floor musculature

• NMES improves function of the urethral and levator ani muscles

• Includes smooth and striated muscle types

Postulated that NMES in Patients with SUI

• Increases the proportion of fast twitch fibers
• Increases the number and strength of slow twitch fibers,

improving resting urethral closure
• Improves recruitment of pelvic muscle fibers when performing

voluntary muscle contractions

Worsening SUI with NMES

• Patient with SUI initially experiences increased UI after NMES
• May be due to muscle fatigue
• To decrease muscle fatigue

• Reduce the amount of time/session length NMES
• Select a less aggravating duty cycle (time on/time off) ratio

• Instead of 1:1 select 1:2

• Do not reduce the intensity as this could reduce the therapeutic effect

• The intensity level (amplitude) must elicit a muscle contraction

92

NMES for Urgency Urinary Incontinence

• Pudendal nerve

• Pelvic nerve reflex inhibits bladder contractions

• Frequencies of < 15HZ induce bladder inhibition due to
pudendal to hypogastric nerve reflex

• Sacral afferent sensory nerves

• Innervate the bladder
• Tend to be poorly myelinated C fibers
• Conduct at a slow rate

• Rationale for using the frequency rate of 13HZ for UUI

NMES Decreases Detrusor Overactivity
in the Following Manner

• Stimulation of the reflex systems which influence the urethra
and PFM during detrusor contractions

• Improved reflex inhibition of the bladder due to stronger PFMs
• Reorganization or reeducation of neural pathways which

provide central or peripheral control

NMES for Chronic Pelvic Pain Syndrome

• Provides pain relief
• Used to produce rhythmic contraction and relaxation of the PFMs
• May reduce muscle spasm and trigger points by fatiguing PFMs
• Repeated contractions may help to disperse products of

inflammation caused by chronic muscle spasm

93

NMES for Chronic Pelvic Pain Syndrome

• Monitor PFM EMG resting tone before and after NMES
• Recommend home treatments if patient prefers
• 12/50HZ setting can be used for chronic pelvic pain
• 15 minutes at 12HZ followed by 15 minutes at 100HZ
• Use in conjunction with myofascial release/physical therapy
• Can recommend use of heat therapy and daily stretches/yoga

Pelvic Muscle Rehabilitation (PMR)
in the Treatment of Pelvic Floor Disorders

• Purpose

• Eliminate or reduce symptoms of pelvic muscle disorders
• Improve quality of life

• Key components

• Behavioral and lifestyle moderation
• EMG muscle evaluation
• Biofeedback-assisted Electromyogram (EMG)
• Pelvic floor muscle exercise or training program
• Bladder training
• NMES of the pelvic floor and detrusor

5-8 Treatment Sessions

weekly or every other week

94

PMR Modalities

• Anal manometry

• Measure muscle strength

• Vaginal EMG

• Measure resting tone

• Abdominal (accessory muscle) EMG

• Measure use of accessory muscles

• NMES

• Passive physiotherapy PFM and detrusor

Accessory Muscle EMG

• Purpose:

• Monitor contraction of abdominal muscle as an accessory muscle
• To assist in isolation of pelvic floor muscle

Pelvic Floor Muscle EMG

Rectal/Vaginal/surface EMG Sensors
Purpose: PFM biofeedback

95

Anal Manometry

• Air filled balloon placed in the anus
• Records squeeze pressure of levator ani muscles
• Measured from zero
• Measurement of true muscle strength

3 Channel Pelvic Floor Biofeedback

NMES Treatment Protocols

• UUI: 12.5HZ 5:5 15-30 minutes
• SUI: 50-100HZ 5:5 15-30 minutes
• MUI: 50HZ 5:5 15-30 minutes
• FI: 50HZ 5:5 15-30 minutes
• Hypertonic PFM 50 or 100HZ continuous 30 min
• Patient with urinary symptoms 5-8 weekly tx or qoweek
• Patient with high tone pelvic floor biweekly tx for up to 8 weeks

96

Diagnosis & Treatment Algorithm

Diagnosis Treatment

Clinical History EMG Pelvic ~ PMR Strength & conditioning
Exam: I&O cath & muscle ~ NMES
weakness ~ muscle isolation
POPQ Manometry
PFM exam Poor ~PMR for endurance training
Endurance ~NMES
~Muscle isolation
Spasm
~PMR for muscle down-training
Accessory ~NMES
muscle ~Physical therapy
overuse ~Muscle isolation

~PMR for muscle isolation
~NMES
~Physical therapy

Coding and Billing

• Varies in different areas of the USA
• Medicare coverage can vary from private insurers
• Coverage can change annually

Treatment CPT Code

• 90911 Biofeedback training, perineal muscles, anorectal or
urethral sphincter, perineal muscles, anorectal or urethral
sphincter, including EMG and/or Manometry

• 91122 Anal Manometry
• 97032 NMES (timed code 15 minutes) often bundled
• Billing for biofeedback (90911) and 97032 on the same day

require a 59 modifier on the 97032 as it is bundled with 90911
• 51784 Accessory muscle EMG
• 97750 Abdominal EMG

97

Modifier 59

• Used to identify that a procedure was distinct and independent
from other services performed on the same day. Could be a
different procedure.

• Often used for surgical procedures

Modifier 25

• Used for a significant, separately identifiable E/M service.
• Documentation needs to be available in the patient’s record to

support the distinct, significant, separately identifiable nature of
the evaluation and management service.

Modifier 26

• Used to indicate the professional component of the service
being billed was "interpretation only," and it is most commonly
submitted with diagnostic tests

• Include with 91122 (anal manometry), 97750 and 51784

98

ICD 10 Codes

• N39.3 Stress incontinence
• N39.41 Urge incontinence
• N39.46 Mixed incontinence
• M62.20 Muscle weakness and disuse atrophy
• M62.838 Spasm of muscle
• K59.4 Anal spasm
• R15.9 Incontinence of feces
• K59.00 Constipation (if performing anal manometry)

ICD 10 Codes

• N36.42 Intrinsic sphincter deficiency (ISD)
• R32 Unspecified urinary incontinence
• N32.81 Overactive bladder
• R39.15 Urinary urgency
• N39.43 Post-void dribbling
• R35.1 Nocturia
• N39.44 Nocturnal enuresis
• R39.14 Incomplete bladder emptying
• R33.9 Urinary retention

Key Points

• NMES is a practical alternative with few side-effects, and is
effective for treating female urinary incontinence

• PMR including biofeedback & vaginal NMES had a high rate of
satisfaction and should be considered in patients
with pelvic floor dysfunction.

• Better methodological quality studies are needed to obtain a
higher level of scientific evidence and to know the optimal
current modality, type and parameters for each type of UI and
OAB

99

Case Studies

Arnold Kegel, M.D

Combined vaginal pelvic floor electrical stimulation (PFS) and local vaginal
estrogen for treatment of overactive bladder (OAB) in perimenopausal females.
Randomized controlled trial (RCT)

OBJECTIVE: To evaluate the efficacy of combined vaginal NMES and local vaginal estrogen in treatment of female OAB.
MATERIAL AND METHODS:
RCT 315 perimenopausal females with OAB who were randomly allocated into 3 equal groups.
Group A Vaginal NMES twice weekly for 12 sessions. Group B received local vaginal estrogen, whereas group C received both NMES and
local estrogen. All patients were evaluated by a voiding diary, quality-of-life questionnaire, vaginal examination, UA, blood sugar,
ultrasonography, and UDS before and after therapy. Patients were followed up 1 week, 3, and 6 months post-therapy.
The analyzed variables included day and night time frequency, incontinence episodes, urgency, quality of life, detrusor overactivity, and
functional bladder capacity. Outcome measure was urge incontinence.
RESULTS:
Within each group, there was a statistically significant improvement in all variables after treatment. Improvement of urgency was better in
group C than in groups A and B (P = .000, .009). Improvement of incontinence was better in groups A and C than in group B (P = .005, .004).
Follow-up showed worsening of symptoms within 6 months in all groups except incontinence in group C.
CONCLUSION:
Vaginal NMES and estrogen found to be effective in treating OAB symptoms in perimenopausal females.
Estrogen seems to augment the effect of PFS especially in the treatment of urgency incontinence and can delay its recurrence.

Abdelbary AM, El-Dessoukey AA, Massoud AM, Moussa AS, Zayed AS, Elsheikh MG, Ghoncima W, Agdela R, Yousef M. (2015) Combined vaginal
pelvic floor electrical stimulation (PFS) and local vaginal estrogen for treatment of overactive bladder (OAB) in perimenopausal females.
Randomized controlled trial (RCT). Urology. Sep;86(3):482-6

Comparison of the effects of electrical stimulation and posterior
tibial nerve stimulation in the treatment of overactive bladder
syndrome

AIM:
To compare the effects of transvaginal electrical stimulation (ES) and posterior tibial nerve stimulation (PTNS) in
the treatment of overactive bladder syndrome (OAB).
METHODS:
Women applying with symptoms of urgency, frequency, and nocturia with or without incontinence and diagnosed with OAB
were divided into an ES or PTNS group. Bladder diary, urodynamics, 1-hour pad test, and King's Health Questionnaire
were performed before and after treatment. ES was applied for 20 min, 6-8 weeks with pulses of 10-50 Hz square waves
at a 300-µs or 1-ms pulse duration and a maximal output current of 24-60 mA with 5-10 Hz frequency, three times per
week. PTNS was applied for 30 min once a week for 12 weeks.
RESULTS:
Thirty-five patients received ES, 17 patients received PTNS. Pad test, urinary diary, and quality of life parameters after
both treatments decreased significantly; the decrease in the ES group was greater. The number of patients who describe
themselves as cured was higher in the ES group.
CONCLUSION:
PTNS and ES are both effective in the treatment of OAB with significant improvement in objective and subjective
parameters. Objective results show no significant difference between the two groups; however, the number of patients
who describe themselves as cured in the ES group was significantly higher

Gungor Ugurlucan F., Onal M., Aslan E., et al: Comparison of the effects of electrical stimulation and posterior tibial nerve stimulation in the treatment
of overactive bladder syndrome. Gynecol Obstet Invest 2013; 75: pp. 46-52

100

Pelvic floor electrostimulation in women with urinary incontinence
and/or overactive bladder syndrome: A systematic review

CONTEXT:
Electrostimulation (ES) is one of the techniques employed in conservative treatment of urinary incontinence (UI) and/or overactive
bladder syndrome (OAB). Nevertheless, there is controversy in the scientific literature regarding its effectiveness as monotherapy.
OBJECTIVE:
To evaluate the scientific evidence on ES of the pelvic floor in women with UI and with/without OAB.
EVIDENCE ACQUISITION:
A systematic review of clinical trials was carried out in the following databases: PubMed, Cochrane, PEDro, Elsevier (Doyma) and EnFisPo
(1980-2011). Quality of study registries was evaluated and information was obtained from those that presented the inclusion criteria
established in the review.
EVIDENCE SYNTHESIS:
The 27 clinical trials were included in the review: 13 randomized controlled trials, 11 randomized non-controlled trials and 3 non-randomized
trials.
CONCLUSION:
Most of the clinical trials conclude that ES is effective in the treatment of UI and OAB in women. However, better methodological quality
studies are needed to obtain a higher level of scientific evidence and to know the optimal current modality, type and parameters for each type
of UI and OAB
Jerez-Roig, J., et. al. (2012). Pelvic floor electrostimulation in women with urinary incontinence and/or overactive bladder syndrome: A systematic review. Actas Uro Esp. 37:429-444

Transvaginal electrical stimulation in the treatment of
urinary incontinence

OBJECTIVE:
To determine the effectiveness of transvaginal electrical stimulation (TES) in treating urinary incontinence, and to assess
the clinical improvement 6 months after ending the treatment.
PATIENTS AND METHODS:
In a double-blind randomized controlled clinical trial, 36 women (24 patients and 12 controls) with stress, urge or
mixed urinary incontinence were chosen to use TES or placebo (identical equipment but with no electrical current). The
patients had their treatment at home twice a day (20-min sessions) for 12 weeks. They completed a voiding diary and had
a urodynamic study at the beginning and end of treatment. They were clinically re-evaluated after 6 months.
RESULTS:
The mean time of use of TES was similar in both groups (approximately 40 h); the treatment group had a significant
increase in maximum bladder capacity (P < 0.02), a significant reduction in the total number of voids (over 24 h; P < 0.02),
in the number of episodes of voiding urgency (P < 0.001) and, importantly, in the number of episodes of urinary
incontinence (P < 0.001). At the first evaluation, after ending the treatment, 88% of the patients had a significant reduction
in symptoms or went into remission. At the 6-month re-evaluation, a third of the patients required another therapeutic
approach.
CONCLUSION:
TES is a practical alternative with few side-effects, and is effective for treating the main forms of female urinary
incontinence

Barroso JC, Ramos JG, Martins-Costa S, et al. Transvaginal electrical stimulation in the treatment of urinary incontinence. BJU INT 2004;93(3)319-323.

Cochrane Review: Anticholinergic drugs versus non-drug active
therapies for non-neurogenic overactive bladder syndrome in
adults

AUTHORS' CONCLUSIONS:
The use of anticholinergic drugs in the management of overactive bladder syndrome is well
established when compared to placebo treatment. During initial treatment of overactive
bladder syndrome there was more symptomatic improvement when (a) anticholinergics
were compared with bladder training alone, and (b) anticholinergics combined
with bladder training were compared with bladder training alone.
Limited evidence from small trials might suggest electrical stimulation is a better option in
patients who are refractory to anticholinergic therapy, but more evidence comparing
individual types of electrostimulation to the most effective types of anticholinergics is
required to establish this.
These results should be viewed with caution in view of the different classes and varying
doses of individual anticholinergics used in this review. Anticholinergics had well recognized
side effects, such as dry mouth

Rai, B., Cody, J., Alhasso, A., & Steward. L. (2012). Cochrane Review: Anticholinergic drugs versus non-drug active therapies for non-neurogenic
overactive bladder syndrome in adults. The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Issue 12

101

Intravaginal electrical stimulation: a randomized, double-blind
study on the treatment of mixed urinary incontinence

BACKGROUND:
The aim of this study was to compare effective and sham intravaginal electrical stimulation (IES) in treating mixed urinary incontinence.
METHODS:
Between January 2001 and February 2002, 40 women were randomly distributed, in a double-blind study, into two groups: group G1 (n=20),
effective IES, and group G2 (n = 20), sham IES, with follow up at one month. Different parameters was studied: 1. clinical questionnaire; 2.
body mass index; 3. 60-min pad test; 4. urodynamic study. The protocol of IES consisted of three 20-min sessions per week over a seven-
week period. The Dualpex Uro 996 used a frequency of 4 Hz.
RESULTS:
There was no statistically significant difference in the demographic data of both groups. The number of micturitions per 24 h
after treatment was reduced significantly in both groups. Urge incontinence was reduced to 15% in G1 and 31.5% in G2; there was no
significant difference between the groups. In the analog wetness and discomfort sensation evaluations were reduced significantly in both
groups. The pretreatment urodynamic study showed no statistical difference in urodynamic parameters between the groups. Ten percent of
the women presented involuntary detrusor contractions. In the 60-min pad test, there was a significant reduction in both groups. In regards to
satisfaction level, after treatment, 80% of G1 patients and 65% of G2 patients were satisfied. There was no statistically significant difference
between the groups.
CONCLUSION:
Significant improvement was provided by effective and sham electrostimulation, questioning the effectiveness of electrostimulation as a
monotherapy.
Amaro J.L., Gameiro M.O., Kawano P.R., et al: Intravaginal electrical stimulation: a randomized, double-blind study on the treatment of mixed

urinary incontinence. Acta Obstet Gynecol Scand 2006; 85: pp. 619-622

Randomized, double-blind study of electrical stimulation
for urinary incontinence due to detrusor overactivity

OBJECTIVES:
To evaluate the usefulness of electrical stimulation for urinary incontinence due to detrusor overactivity in a randomized, double-
blind manner.
METHODS:
Sixty-eight patients (29 men, 39 women, 70.0 +/- 11.2 years) were studied. Detrusor overactivity was urodynamically defined as
involuntary detrusor contractions of more than 15 cm H(2)O during the filling phase. Ten-hertz square waves of 1-ms pulse duration were
used. A vaginal electrode was used in the women and an anal or surface electrode in the men. The stimulation was given for 15 minutes
twice daily for 4 weeks. The efficacy was evaluated on the basis of a frequency/volume chart and urodynamic study before and after
treatment.
RESULTS:
Thirty-two patients in the active group and 28 in the sham group completed the study. The patient impressions were very good or good in
59% and 39% of the active and the sham group, respectively (P = 0.0354). On the cystometrogram, the bladder capacity at the first desire to
void and the maximum desire to void increased significantly (P = 0.0104 and P = 0.0046, respectively) in the active group, but not in the
sham group. Seven patients in the active group and 1 patient in the sham group were cured (P = 0.0324); 26 patients (81.3%) in the active
group and 9 (32.1%) in the sham group improved (P = 0.0001). Of 17 patients in the active group, 13 remained cured or improved for an
average of 8.4 months after completion of the 4-week treatment; in the sham group, 3 of 6 patients were cured or improved for an average of
4.7 months after completion of the 4-week treatment.
CONCLUSIONS:
Electrical stimulation was useful in treating urinary incontinence due to detrusor overactivity.
Yamanishi T., Yasuda K., Sakakibara R., et al: Randomized, double-blind study of electrical stimulation for urinary incontinence due to detrusor

overactivity. Urology 2000; 55: pp. 353-357

Prospective Outcomes of a Pelvic Floor Rehabilitation Program Including
Vaginal Electrogalvanic Stimulation for Urinary, Defecatory, and Pelvic
Pain Symptoms

OBJECTIVES:
This study evaluated our experience after implementing a pelvic floor rehabilitation program including behavioral modification, biofeedback,
and vaginal electrogalvanic stimulation (EGS).
METHODS:
This prospective cohort study evaluated outcomes of patients with pelvic floor dysfunction
(urinary or defecatory dysfunction, pelvic pain/dyspareunia) who underwent pelvic floor rehabilitation. Patients received 4 to 7 sessions (1
every 2 weeks) including biofeedback and concluded with 30 minutes of vaginal EGS. Surveys assessed subjective changes in symptoms;
success was evaluated using a 10-point visual analog scale (VAS) at the final session (10 = most successful). Paired comparisons of
responses at baseline and final treatment were evaluated.
RESULTS:
Ninety-four patients were followed up through therapy completion. Treatment indications included urinary (89.4%), defecatory(33.0%),
and pelvic pain or dyspareunia (30.9%); 44.7% of patients had a combination of indications. Among women with urinary symptoms, the
percentage reporting leakage decreased from 92.9% to 79.3% (P = 0.001), leakage at least daily decreased from 69.0% to 39.5% (P <
0.001), daily urgency with leakage decreased from 42.7% to 19.5% (P = 0.001), daily urgency without leakage decreased from 41.5% to
18.3% (P < 0.001), and median VAS rating (0 = not at all, 10 = a great deal) of daily life interference decreased from 5 to 1.5 (P < 0.001). The
median success ratings were 8, 8, and 7 for treatment of urinary symptoms, pelvic pain/dyspareunia, and bowel symptoms, respectively.
CONCLUSIONS:
An aggressive pelvic rehabilitation program including biofeedback with vaginal EGS had a high rate of self-reported subjective success and
satisfaction and should be considered a nonsurgical treatment option in patients with pelvic floor dysfunction.
Schmitt J, Ruchira S, Harvey-Springer R, Fick F, Occhino R. Prospective Outcomes of a Pelvic Floor Rehabilitation Program Including Vaginal Electrogalvanic

Stimulation for Urinary, Defecatory, and Pelvic Pain Symptoms. Female Pelvic Med Reconstr Surg. 2017 Mar/Apr;23(2):108-113

102

References

Davis K, Kumar D, Stanton SL. Pelvic floor dysfunction: the need for a multidisciplinary team approach. J Pelvic Med Surg.
2003;9(1):23-36.

Butrick CW. Pathophysiology of pelvic floor hypertonic disorders. Obstet Gynecol Clin North Am. 2009;36(3):699-705.
Finamore PS, Goldstein HB, Whitmore KE. Pelvic floor muscle dysfunction: a review. J Pelvic Med Surg. 2008;14(6):417-422.
Butrick CW. Pelvic floor hypertonic disorders: identification and management. Obstet Gynecol Clin N Am. 2009;36(3):707-722.
Bump RC, Norton PA 1998 Epidemiology and natural history of pelvic floor dysfunction. Obstet Gynecol Clin North Am. 25(4):723-746.
Hay-Smith J, Herderschee R, Dumoulin C, et al. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in

women: an abridged Cochrane systematic review. Eur J Phys Rehabil Med. 2012;48(4):689-705.
Jerez-Roig, J., et. al. (2012). Pelvic floor electrostimulation in women with urinary incontinence and/or overactive bladder syndrome: A

systematic review. Actas Uro Esp. 37:429-444

References

Hay-Smith J, Herderschee R, Dumoulin C, et al. Comparisons of approaches to pelvic floor muscle training for urinary
incontinence in women: an abridged Cochrane systematic review. Eur J Phys Rehabil Med. 2012;48(4):689-
705.

Barroso JC, Ramos JG, Martins-Costa S, et al. Transvaginal electrical stimulation in the treatment of urinary incontinence.
BJU INT 2004;93(3)319-323.

Rai, B., Cody, J., Alhasso, A., & Steward. L. (2012). Cochrane Review: Anticholinergic drugs versus non-drug active
therapies for non-neurogenic overactive bladder syndrome in adults. The Cochrane Collaboration. Published by
John Wiley & Sons, Ltd. Issue 12

Starr JA, Drobnis EZ, Lenger S, Parrot J, Barrier B, Foster RT. Outcomes of a comprehensive nonsurgical approach to
pelvic floor rehabilitation for urinary symptoms, defecatory dysfunction and pelvic pain. J Pelvic Med Surg.
2013;95(5)260-265.

Shamliyan, T., et al. (2008). Systematic review: Randomized, Controlled Trials of nonsurgical treatments for urinary
incontinence in women. Annals of Internal Medicine. 148:6; 459-474

References

Amaro J.L., Gameiro M.O., Kawano P.R., et al: Intravaginal electrical stimulation: a randomized, double-blind study on the
treatment of mixed urinary incontinence. Acta Obstet Gynecol Scand 2006; 85: pp. 619-622

Smith J.J.: Intravaginal stimulation randomized trial. J Urol 1996; 155: pp. 127-130
Abel I, Ottesen B, Fischer-Rasmussen W, et al. Maximal electrical stimulation of the pelvic floor in the treatment of urge

incontinence: A placebo controlled study. Proceedings of The 26th Annual Meeting International Continence
Society. 1996;15:283-284.
Yamanishi T., Yasuda K., Sakakibara R., et al: Randomized, double-blind study of electrical stimulation for urinary
incontinence due to detrusor overactivity. Urology 2000; 55: pp. 353-357
McGuire E.J., Zhang S.C., Horwinski E.R., et al: Treatment of motor and sensory detrusor instability by electrical
stimulation. J Urol 1983; 129: pp. 78
Gungor Ugurlucan F., Onal M., Aslan E., et al: Comparison of the effects of electrical stimulation and posterior tibial nerve
stimulation in the treatment of overactive bladder syndrome. Gynecol Obstet Invest 2013; 75: pp. 46-52

103

Arnold Kegel, M.D.-Obstetrician & Gynecologist

104

Notes

Third‐Line OAB Therapies

Brian J. Linder, MD, MS
@brianjlinder

Assistant Professor of Urology, OB/Gyn
Mayo Clinic, Rochester, MN

Disclosures

None
I use all three treatments clinically

Objectives

• Discuss the utility of an OAB care pathway
• Describe the available third‐line OAB therapies
• Recognize the unique risk/benefit profiles to each of the third‐line

therapy options and how they impact treatment selection

105

OAB Management Options

• Lots of guidelines:
• AUA Guideline (updated 2014)
• EAU Guideline (updated 2014)
• CUA Guideline (updated 2012)
• International Consultation on Incontinence Guideline (updated 2013)
And now…

Overactive Bladder

• Urinary urgency, +/‐ incontinence, without obvious pathology 1
• Presence of bother 2

1 Haylen BT et al, Neurourol Urodyn, 2010
2 Gormley EA et al, J Urol, 2015

AUA guideline

Gormley EA et al, J Urol, 2015

106

Third‐Line Therapies

• Options: 1
• Sacral neuromodulation 
• Botox™(intradetrusor onabotulinumtoxin A)
• Percutaneous tibial nerve stimulation (PTNS)

• ~3% of OAB patients 2
• Use of a care pathway may increase this

1 Gormley EA et al, J Urol, 2015
2 Moskowitz D et al, J Urol ,2017

Percutaneous Tibial Nerve Stimulation: PTNS

(Peters KM et al. J Urol 2010)

107

PTNS in Practice

• 12 weekly office sessions
• 34 G (acupuncture) needle 
• Inserted near medial malleolus 
• Stimulation level adjusted to appropriate setting
• 30 min. treatment
• Pts can drive themselves to/from appt

• If benefit, go on to maintenance (~q3 weeks)

PTNS Risks and Contraindications

• Risks
• Minor bleeding
• Transient leg pain

• Contraindications
• Bleeding tendency
• Pregnant or considering becoming pregnant
• Cardiac pacemaker 
• Peripheral neuropathy

PTNS vs Placebo or Meds

• RCT compared to Tolterodine (n=84), 3mo
• PTNS (79.5%) 
• Tolterodine (54.8%; p=0.01)

• RCT compared to sham procedure (n=220), 3mo
• PTNS (54.5%) 
• Sham (20.9%; p<0.01)

1 Peters KM et al, J Urol, 2009
2 Peters KM et al, J Urol, 2010

108

PTNS vs Sacral neuromodulation

• 5 randomized trials for SNM, 4 for PTNS….
• Pooled success rates 

• Sacral neuromodulation: 61% to 90% 
• PTNS: 54% to 79% 

1 Tutolo M et al, Eur Urol Focus, 2018

Future Applications

• Implantable tibial lead 1

• One available study: 34 patients‐ 71% had  > 50% improvement, 

27.6% dry 2 1 Guzman-Negron KM et al, Curr Urol Rep, 2017
2 Abstract- ICS 2016, Neurourol Urodynam, 2016;35(S4):S45–6.

Intradetrusor onabotulinumtoxinA

Allergan, 2013

109

In Practice

• Cystoscopic procedure (office or OR)
• Topical lidocaine instilled in bladder
• Injection scope and needle
• injeTAK® needle (depth of 3mm)
• Can be done with rigid or flexible cystoscopy

Clinical Procedure

• 3 days of ppx abx pre‐procedure
• Negative UA prior to procedure
• At procedure: 2% Lidocaine Hydrochloride (Hcl)  (URO‐Jet) instilled via urethra

• Lidocaine 1% 30cc instilled into bladder via Foley catheter 
• Medication dwells 20‐30 min, bladder drained, catheter removed
• 100 Units of Botox in 10mL NS for idiopathic OAB
• 1 day of ppx abx post‐procedure

OnabotulinumtoxinA Injection

• Significant improvements in QoL 1‐2
• 60‐70% significant improved, 25% dry1‐2
• Median response is 6 mo 1‐2

• Takes 1‐2 wks before onset

• Contraindications

• Active infection
• Elevated PVR
• Unwilling/able to catheterize
• Dysphagia
• Pre‐existing neuromuscular disorder (myasthenia gravis)

1 Nitti VW et al, J Urol, 2013
2 Chapple C et al, Eur Urol, 2013

110

OnbotulinumtoxinA Risks

• UTI
• Hematuria
• Urinary retention

• 7%‐20% 1,2
• Risk factors

• Pt must be able/willing to do CIC if needed
• Frail patients, hand function (e.g. rheumatoid 
arthritis), obesity, etc.
• Length of retention: median 8 wks 2

1 Liberman D et al, FPMRS, 2018
2 Nitti VW et al , J Urol, 2016

Sacral Neuromodulation

• Implantable, programmable neuromodulation system

111

Sacral Neuromodulation

• Two stage therapy
• Lead Implant: Placement of lead and trial period
• Proceed if >50% improvement in sx
• Assessed via bladder diary

Sacral Neuromodulation

• Basic evaluation (PNE)
• Office based lead placement, 3‐7 d trial
• Fluoroscopy preferred
• If successful proceed to full implantation under anesthesia

• Advanced evaluation (under anesthesia x 2)
• Lead Implant: Placement of tined lead, 1‐2 wk trial
• If successful proceeds to IPG placement

Neuromodulation Indications

• Refractory OAB
• Failed or not sufficiently improved by drugs and behavioral 
therapy
• Non‐neurogenic etiology

• Urinary Retention
• Idiopathic non‐obstructive

• Accidental Bowel Leakage (FI)

112

Interstim Lead Placement

AP View Lateral View

Sacral Nerve Responses

Sacral Nerve Motor Response Sensory Response

Foot plantar flexion, lateral 

S2 rotation Leg and buttock

Great toe dorsiflexion,  Paresthesias or sensation of 

S3 Bellows reflex * pulling in vagina, rectum

Sensation of pulling in 

S4 Bellows reflex rectum only

*Bellows before toe response is ideal

Technical Considerations

• No muscle relaxants in the OR

• Use of curved stylet 1

• As high and medial in S3 foramen as possible 2,3

• Thresholds under 2V for all 4 contacts 2‐4
• Longer battery life
• Better efficacy
• More options for reprogramming
• Decreased peripheral stimulation

1 Jacobs SA et al, Neurourol Urodynam, 2014 3 Goldman HB et al, Neurourol Urodynam, 2018
2 Libermann D et al, Urology, 2016 4 Pizzaro J et al, J Urol, 2018

113

Technical Considerations

• IPG pocket no deeper than 2.5 cm
• Distance for wireless communication
• Infection risk 1

1 Myer EB et al, Am J Obstet Gynecol, 2018

Randomized Data at 6 mo

80

70

60 Percent of UI Responders

50 71% p<0.05 50 – 99%
Therapeutic

Improvement

40

30 47% 100% Therapeutic
Improvement (Dry)
39%

20

21%

10

0 Standard
Medical
SNM Therapy
n=38
n=57

Success is ≥ 50% improvement in average leaks/day from baseline

Siegel SW, et al. Neurourol Urodyn. 2015

5‐year Data (INSITE)

Siegel SW et al, J Urol, 2018

Overall, how much do your urinary symptoms interfere with your everyday life?
*272/340 (80%) went on to implant from test

114

Sacral Neuromodulation vs Botox

• Randomized Trial‐ ROSETTA 1,2
• 386 women randomized
• Primary outcome was change from baseline in mean daily UUI over a 6‐mo
• Secondary outcomes included quality of life, satisfaction, and adverse events
• Interventions were:

• Sacral neuromodulation (two stages) 
• Intradetrusor onabotulinumtoxinA injection (200 U)

Amundsen CL et al, Contemp Clin Trials, 2014
Amundsen CL et al, J Urol, 2016 Vol. 195, No. 4S, e949‐50

Outcome data were available for 260/298 (87%) clinical responders

Randomized Data‐ Botox vs SNM

• Slightly higher pt satisfaction w/ Botox
• Higher retention and UTI w/ Botox

• Caveat: Botox 200 U
• SNM revision and removals occurred in 3%  and 9%
• “…both therapies offer sustained reduction in daily incontinence over 2 yr”

115

Other Considerations

• MRI limitations with SNM*

• Can get head MRI with 1.5T magnet
• Developing topic: 11 pts underwent lumbosacral MRI 1

• No change in device efficacy
• No significant adverse events

• Less frequent retreatment than with Botox
• 3‐5 yrs for battery, though may need other revision
• ~6 mo for onabotulinumtoxinA

1 Guzman‐Negron JM et al. J Urol, 2018

MRI details

• According to the manufacturer's labeling (2012 manufacturer’s instructions for use [IFU]), non‐
clinical testing has demonstrated that InterStim Therapy systems have been found to be MR 
Conditional. If a patient is implanted with an InterStim II Model 3058 Neurostimulator or an 
eligible serial number of an InterStim Model 3023 Neurostimulator (when implanted as a system 
including a neurostimulator, lead, and extension as applicable), MRI examinations of the head 
only may be safely performed under the following conditions:

• 1.5‐Tesla (T) horizontal closed bore
• Maximum spatial gradient of 19 T/m (1900 gauss/cm)
• RF transmit/receive head coil only (no RF transmit body coil)
• Gradient slew rate limited to 200 T/m/s
• Normal operating mode (Scanning frequency of approximately 64 MHz only)
• If possible, do not sedate the patient
• Model 3058 and eligible Model 3023 Neurostimulators: Turn the neurostimulator off
• Eligible Model 3023 Neurostimulators only: Disable the magnet switch
• Also see Medtronic product information, instructions on website

Goldman HB et al, Neurourol Urodynam, 2018

Post SNM Troubleshooting

Goldman HB et al, Neurourol Urodynam, 2018

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SUFU Care Pathway

Summary

PTNS Pros Cons Retreatment
OnabotulinumtoxinA
Sacral neuromodulation Least invasive, lowest risk  Likely lowest efficacy.  Maintenance therapy ~q3 
(no retention, UTI, device  12 wkly treatments wks

revision)

Office procedure, no  Retention, UTI risks ~ 6mo
restriction on MRIs, 
approved for neurogenic 

population

Durable, no risk of  Implanted device,  Battery exchange (~3‐5 
retention, also treats  limits MRI*, yrs), device infection, 

FI/bowel issues,  anesthestic, can be  revision
reversible damaged with a fall, pt

programmer

* Head MRI with 1.5T magnet conditional approval

117

Thank you

Email: [email protected]
@brianjlinder

118

Notes

Landmark Research

Rebecca G Rogers, MD
Professor
Dell Medical School
University of Texas,
Austin, TX

Disclosures

• Uptodate Royalties
• Travel and Stipend from ABOG, ACOG and IUGA

“If we knew what we were doing, it 
wouldn’t be called Research”
‐A Einstein

119

Landmark #1

How do we decide what evidence to believe?

Relevant to your practice
Intervention reproducible
Outcome important in clinical practice
Design minimizes biases

ATLAS Trial: A Trial of Continence Pessary vs. Behavioral 
Therapy vs. Combined Therapy for Stress Incontinence
• RCT
• Women with stress alone or stress 

predominant incontinence
• Comparison groups‐

• Behavioral therapy ‐ 4 visits

• Pelvic floor muscle training with 
individualized prescriptions

• Pessary ‐ continence ring or dish
• Combined‐ both

Richter. Obstet Gynecol 2010

120

What makes for good outcome measures?

What is the primary outcome?
When was it measured?
How measured?

ATLAS – Outcome Measures

• 1o  Outcomes‐

• Patient Global Impression of Improvement‐ success 
“much better” or “very much better”

• UDI ‐ stress ‐ no bothersome stress incontinence

• 3, 6 and 12 months
• Masked interviewers 

Other important issues in trial design…POWER
•150 women/group ‐ 80% power; 
15% difference in PGI‐I at 3 
months, as well as 80% power to 
detect whether combined 
therapy was superior to both 
treatments alone

121

Landmark #2

ATLAS ‐ Results

• 446 women randomized

Other important issues in trial design…Intent 
to treat and per protocol
•Intent to treat – remain in 
assigned category 
•Per protocol – compare only 
those who receive 
intervention

122

ATLAS – Outcomes‐ PGI‐I at 3 months

• 446 women randomized
• ITT 

• 46% reported that they were “much better” or 
“very much better” (pessary 40%, behavioral 49%, 
combined 53%) 

• Combined not better than single therapy

• Per protocol analysis 

• 54–68% reported that they were “much better” or 
“very much better” no differences among groups 

ATLAS – Outcomes 12 months

• ITT –
• PGI‐I ‐32% “much better” or “very much better” 
• PFDI – 36% no bothersome stress incontinence 
• Bladder diary ‐ 35% had at least a 75% reduction of 
incontinence episodes 
• Satisfaction 50–54% 

• Per protocol analysis
• PGI – I and PFDI ‐ 41–61%
• Satisfaction 85–91%

Landmark #3

123

How do we decide what evidence to believe?

Relevant to your practice
Intervention reproducible
Outcome important in clinical practice
Design minimizes biases

So What?

• How this trial changed my practice

• Quote reasonable outcomes
• Stopped offering PT and pessary at the same time
• Patient choice

Landmark #4 – Driskill Bar and Hotel

124

ROSETTA – OnabotulinumtoxinA (BTX) vs 
Sacral Neuromodulation (SNS) on Refractory 
Urgency Urinary Incontinence(UUI)

• RCT

• Refractory UUI‐

• Failed 1 supervised physical therapy and 
2 anticholinergics 

• 6 UUI episodes on 3 day diary

• Comparison Groups:

• 200 U BTX – in clinic

• SNS – in OR Amundsen JAMA 2016

ROSETTA

• 1o  Outcome –Bladder diary ‐ change in daily episodes 
of UUI 

• Other outcomes ‐

• Overactive Bladder Questionnaire Short Form (SF)

• Masked interviewers
• Power ‐ 190 participants per group ‐ 80% power to 

detect a difference of 2 or more UUI/per day  

Do we believe?

Relevant to your practice
Intervention reproducible
Outcome important in clinical practice
Design minimizes biases

125

ROSETTA ‐ Results

• 480 women enrolled, 386 randomized and 364 were 
available for primary outcome analysis 

126

Adverse Events

How were they collected?
Are they important events?
Do they outweigh the good of the intervention?

ROSETTA Adverse Events

AE Type BOTOX SNS P 

Urinary Tract Infection (%) 35 11 <.001

Device Revision or Removal (%) 0 3

Intermittent Catheterization (%) 20 0

BTX Wins? 2 year outcomes…

• 260/298 (87%) clinical responders
• Bladder diary ‐ UUIE ‐3.88 vs ‐3.50 /d (P=0.15)
• BTX satisfaction higher (mean difference=‐9.14, 95% CI=‐14.38‐

‐3.90; (P<0.001), 
• Treatment endorsement higher (mean difference=‐12.16, 95% 

CI=‐17.7‐‐6.63 (P<0.001) 
• UTIs were higher after BTX (24% vs 10%; p<0.01)
• 6% required intermittent catheterization post second injection
• SNM 3% revision and 9% removals

Amundsen Eur Urol 2018

127

So What?

• More likely to offer BTX
• Counseling is more refined
• If woman has recurrent UTI – less likely to offer BTX

Landmark #5

“I don’t want that mesh they are talking 
about on TV”

128

Long‐term Rate of Mesh Sling Removal Following 
Midurethral Mesh Sling Insertion Among Women 
With Stress Urinary Incontinence

• Retrospective Cohort Study
• Exposures: Retropubic or transobturator mesh sling
• Outcomes

• 1o ‐mesh removal (partial or total) 
• 2o ‐ reoperation for SUI and any reoperation

• Setting: NHS in England‐April 1, 2006 until April 1, 
2016.

Gurol‐Urganci JAMA 2018

Do we believe?

Relevant to your practice
Intervention reproducible
Outcome important in clinical practice
Design minimizes biases

Results

• 95,057 women –

• 60,194 retropubic
• 34,863 transobturator

• Median follow‐up 5.5 years 
• Removal ‐ 3.3% (95% CI, 3.2‐3.4%) at 9 years

• Removal higher (at all time points) for retropubic insertion 
(3.6 vs 2.7% at 9 years after insertion)

• Reoperation ‐ 4.5% (95% CI, 4.3%‐4.7%) at 9 years

• Reoperation higher (at all time points) for transobturator
(5.3 compared with 4.1% at 9 years after insertion)

• Any operation ‐ 6.9% (95% CI, 6.7%‐7.1%) at 9 years

129

Results – Reoperation and Mesh Removal

TRANSOBTERATOR

RETROPUBIC REOPERATION
RETROPUBIC REMOVAL

TRANSOBTERATOR

Biases

More common in retrospective studies

So What?

• How this trial changed my practice

• Retropubic less likely to resolve SUI
• Transobturator less likely to be removed
• Rates are low

130

Landmark #5 – 6th Street

POP Surgery

• OPTIMAL at 5 years –

• RCT
• Interventions

• SSLS vs USLS

• Failure –

• Point C descends more than one‐
third of the total vaginal length

• Prolapse beyond the hymen
• Bothersome bulge symptoms 
• Surgery or pessary use

Jelovsek JAMA 2018

Amundsen J Urol 2003 Wheeless Atlas of pelvic 
surgery 2018

131

OPTIMAL

• 285 participants (76.2%) 
• Surgical Failure ‐ 61.5% ULS and 70.3% SSLF group 
• Anatomic failure ‐ 47.5% ULS and 61.8% SSLF group
• Bothersome bulge symptoms ‐37.4% ULS and 41.8% 

SSLF group
• No Differences between groups

POP Surgery

• CARE Long term follow‐up

• Cohort study
• Interventions

• ASC (ALL) RCT Burch vs no Burch

• Failure –

• Point C descends more than one‐third of the total vaginal 
length

• Prolapse beyond the hymen
• Bothersome bulge symptoms 
• Surgery or pessary use

Nygaard JAMA 2013

CARE

Brubaker NEJM 2008

132

Landmark #6

CARE

• 181/302 (60%) women 
• Treatment failure 48% in the Burch group and 34% in 

the no Burch group for POP composite
• Mesh erosion ‐ (6.18 years) was 10.5% (95% CI, 6.8%‐

16.1%)

What do we tell women?

• Repairs are imperfect
• Surgery can be successful, but can fail
• Most women are happy with their surgery, and do not 

have another operation
• We have a lot to do to find the perfect solution

133

134

Notes

Irritable Bowel Syndrome

John A. Occhino, MD, MS

John A. Occhino, MD, MS

@JohnOcchinoMD
• Mayo Clinic

• Associate Professor of ObGyn
• Program Director: FPMRS Fellowship

• Education:

• BA: Miami University, Oxford OH
• MD: University of Cincinnati College of Medicine, Cincinnati OH
• ObGyn Residency: Good Samaritan Hospital, Cincinnati OH
• FMPRS Fellowship: Mayo Clinic, Rochester MN

• Masters of Biomedical Sciences

• Board Certified

• Obstetrics and Gynecology
• FPMRS

Disclosures

• None

135

Objectives

• Define the different subtypes of IBS
• List the 2 major symptoms associated with IBS
• Describe at least 3 pathophysiologic theories for IBS

Overview

• Epidemiology
• Pathophysiology
• Diagnostic Criteria
• Evaluation
• Treatment

Bowel Dysfunction

Ask the question

136

What is IBS?

• Functional disorder of the GI tract

• Chronic abdominal pain
• Altered bowel habits
• Absence of organic disease

Epidemiology

• Prevalence in US – 10-15%

• Less common in patients > 50yo
• Women (14%) > men (9%)

• Up to 40% who meet criteria  no formal diagnosis
• Accounts for 25-50% of GI referrals

Clinical Manifestations & Subtypes

• Chronic abdominal pain • IBS Subtypes

• Cramping, bloating • IBS with predominant constipation (IBS-C)
• Variable intensity • IBS with predominant diarrhea (IBS-D)
• Periodic • IBS with mixed bowel habits (IBS-M)
• IBS unclassified (IBS-U)
• Altered Bowel habits

• Diarrhea - *not bloody
• Constipation – hard pellets
• Alternating
• +/- normal with above symptoms

137