In God we trust, all others must have data

Incontinenza & Prolasso

Michele Meschia - Giancarlo VignoliMichele Meschia - Giancarlo Vignoli

Aims of urodynamics

1. To reproduce the patient’s symptomatic complaints

2. To provide a pathophysiological explanation for the patient’s problems

Role of urodynamics

• 25-30% of women with SUI do not have urodynamic 25-30% of women with SUI do not have urodynamic stress incontinencestress incontinence Glazener 1996Glazener 1996

• In almost half of the patients with OAB symptoms there In almost half of the patients with OAB symptoms there

is no detrusor overactivity on urodynamicsis no detrusor overactivity on urodynamics

Rosenzweig, 1992Rosenzweig, 1992

Stress incontinence & Urodynamics

• Indications:

- Always when surgery is planned

In particular when:• mixed urge and stress symptoms• associated voiding problems• pt with neurologic disorders

Use cystometry if appropriate

• Multi-channel filling and voiding cystometry is recommended before surgery if:– detrusor overactivity suspected– previous surgery has been done for stress UI or

anterior compartment prolapse– symptoms suggest voiding dysfunction

NICE guidelines 2006NICE guidelines 2006

Design of the Value of Urodynamic Evaluation (ValUE) trial:A non-inferiority randomized trial of preoperativeurodynamic investigations.

Background: UDS are routinely obtained prior to surgery for SUI despite a lack of evidence that UDS have an actual impact on outcomePrimary aim: to determine whether women with symptomatic uncomplicated SUI without pre-op UDS have non-inferior treatment outcomes when compared to women with pre-op UDSSecondary aims:• to determine how often physicians use pre-op UDS results to alter clinical and surgical decision-making• to compare the amount of improvement in incontinence outcomes• to determine the incremental cost and utility of performing UDS compared with not performing UDSMethods: UDI and PGI-I responses will be use to measure the primary outcome at 12 months

Nager CW, Brubaker L et al. On behalf of theNager CW, Brubaker L et al. On behalf of theUrinary Incontinence Treatment Network, Contemp Clin Trials 2009Urinary Incontinence Treatment Network, Contemp Clin Trials 2009

Anytime ISD is suspected (higher risk of recurrence)

• Previous incontinence or prolapse surgery• Hypo-mobile or fixed urethra• Severe incontinence with minimal efforts

When are urethral pressure profilometry andleak point pressure measurements useful forevaluation of incontinence?

• MUCP: poor sensitivity and specificity• VLPP : poor reproducibility; techniques not standardized

Some evidence they can predict outcomes ICI 2009ICI 2009

Urodinamica

“Urodynamic investigation should be part of the diagnostic Urodynamic investigation should be part of the diagnostic workup in patients with POP who are candidates for workup in patients with POP who are candidates for surgical repair”surgical repair”

Genital Prolapse

Frequency / Urgency: 85% Frequency / Urgency: 85%

Voiding dysfunction: 34-62%Voiding dysfunction: 34-62%

Difficulty empting: 49% Incomplete voiding: 62% Hesitancy: 34%

POP and urinary symptoms

237 women with POP237 women with POP Urinary incontinence: 73% 73%

Stress: 13% Stress: 13% Urgency: 5%Urgency: 5% Mixed: 76%Mixed: 76%

Ellerkmann, 2001Ellerkmann, 2001

OAB and POP

Symptoms Pre-op Post-op P

Frequency 100% 41% 0.02

Urgency 100% 30% 0.001

Urge incont. 62% 17% 0.001

Diagnoses Pre-op Post-op

DO 61% 34%

Mixed incont 30% 23%

Normal urod. 9% 33%Digesu et al, 2007Digesu et al, 2007

Symptoms and diagnoses before and 1 year after POP surgery

Postoperative resolution of urinary retention in patients with advanced POP

Inclusion criteriaInclusion criteria

Postvoid residual volume > 100 mlPostvoid residual volume > 100 ml

Urodynamics with voiding study (POP reduced)

Results

89% had normal PVR after surgery89% had normal PVR after surgery

Pre-op voiding study as predictor of Pre-op voiding study as predictor of post-op PVR post-op PVR 66% sensitivity; 46% specificity66% sensitivity; 46% specificity 12% positive predictive value 12% positive predictive value 93% negative predictive value93% negative predictive value

FitzGerald, 2000FitzGerald, 2000

POP and SUI

• Women with severe pelvic organ prolapse may be Women with severe pelvic organ prolapse may be continent because of urethral kinking or continent because of urethral kinking or compressioncompression

• Without prolapse reduction only 3.7% of women with III-IV stage prolapse demonstrate urodynamic stress incontinence (Visco et al, 2008)

• OSUI can be suspected if the patient reported a history of SUI which has disappeared with the exacerbation of POP

Incidence of post-op SUIIncidence of post-op SUI

• 11% within 3 months of anterior colporraphy with and 11% within 3 months of anterior colporraphy with and without VH without VH (Stanton et al, 1982)(Stanton et al, 1982)

• 22% 3 months after ant/post colporraphy and cervical 22% 3 months after ant/post colporraphy and cervical amputation amputation (Borstad et al, 1989)(Borstad et al, 1989)

• At five years: 7.5% rate of surgery for SUI following At five years: 7.5% rate of surgery for SUI following successful prolapse surgerysuccessful prolapse surgery (Clark et al,2003) (Clark et al,2003)

Continent patients, no screening for occult SUI, no data on Continent patients, no screening for occult SUI, no data on the severity of prolapsethe severity of prolapse

Occult Stress Urinary IncontinenceOccult Stress Urinary Incontinence

36% to 80% of continent women with 36% to 80% of continent women with POP are at risk to develop SUI afterPOP are at risk to develop SUI after

reconstructive surgeryreconstructive surgery (Kleeman et al 2006; Reena et al 2007)

These women, considered to have occult These women, considered to have occult stress incontinence, can be identified by stress incontinence, can be identified by performing a barrier testperforming a barrier test

Screening for OSUI

• 58% POSUI in women with pre-op positive barrier test who underwent ASC without colposuspension (Brubaker et al, 2006)

• 64.7% of women with positive pre-op pessary test who did not underwent a TVT at the time of prolapse repair developed POSUI(Liang et al, 2004)

The Care TrialThe Care Trial

Women with pre-op positive barrier test were more Women with pre-op positive barrier test were more

likely to report POSUI regardless concomitant likely to report POSUI regardless concomitant

colposuspensioncolposuspension

Burch No Burch P

Total 23.8% 44.1% < .001

Pos barrier test 32% 58% .04

Neg barrier test 21% 38% .007

Incidence of post-op SUIIncidence of post-op SUI

Brubaker et al, 2006

Prolapse reductionProlapse reduction

• A pre-operative negative barrier test result is reliable in predicting patients who will remain stress-continent after prolapse repair (Klukte et al, 2000)(Klukte et al, 2000)

• A negative pre-op barrier test is associated with 2% post-A negative pre-op barrier test is associated with 2% post-op SUI op SUI (Kleeman et al, 2006)(Kleeman et al, 2006)

• Overall barrier tests have low positive predictive values Overall barrier tests have low positive predictive values with pessary having the lowest rate of detection of OSUI: with pessary having the lowest rate of detection of OSUI: 6%; PPV, 50% 6%; PPV, 50% (Visco et al, 2008)(Visco et al, 2008)

Role of urodynamicsRole of urodynamics

• Little evidence to show it is better than barrier methods alone Little evidence to show it is better than barrier methods alone (Roovers et al, 2007)(Roovers et al, 2007)

• Urethral pressure profile and leak point pressure have poor Urethral pressure profile and leak point pressure have poor predictability predictability ( Romanzi et al, 1999)( Romanzi et al, 1999)

• Urodynamics before surgery in women with POP and SUI does not Urodynamics before surgery in women with POP and SUI does not improve cure rates and is not cost-effective relative to basic office improve cure rates and is not cost-effective relative to basic office evaluationevaluation (Weber et al, 2000)(Weber et al, 2000)

• When planning concomitant surgery urodynamics is recommended When planning concomitant surgery urodynamics is recommended to ascertain coexisting problems such as detrusor overactivity or to ascertain coexisting problems such as detrusor overactivity or voiding disordersvoiding disorders. . (Togami et al, 2010)(Togami et al, 2010)

• Detrusor overactivity has been found in up to 30% of patients and Detrusor overactivity has been found in up to 30% of patients and persisted in most of them post-op persisted in most of them post-op (Araki et al, 2009)(Araki et al, 2009)

Does preoperative urodynamics change the Does preoperative urodynamics change the

management of prolapse?management of prolapse?

• 53% of women undergoing UDS had an abnormal result with POP reduction

• 19% had urodynamic SUI• 30% had DO either alone or as MI• The surgical management was altered in 7% of women The surgical management was altered in 7% of women

who had an additional continence procedurewho had an additional continence procedure

Toozs-Hobson, 2008Toozs-Hobson, 2008

• Correct the prolapse first and evaluate afterwards if Correct the prolapse first and evaluate afterwards if

this procedure has also resolved SUI this procedure has also resolved SUI

• Correct the prolapse and stress incontinence during Correct the prolapse and stress incontinence during

the same procedurethe same procedure

Treatment strategiesTreatment strategies

“The goal of treatment of SUI and pelvic prolapse is to correct incontinence and prolapse without creating outlet obstruction”

Prophylactic bladder neck plication is commonly

performed at the time of POP repair

OSUI and vaginal surgery Do nothing

BumpBump

19961996

Colombo Colombo 19971997

Meschia Meschia

20042004

Patient numberPatient number 2929 7373 5050

Type of studyType of study RandomRandom RandomRandom RandomRandom

ProcedureProcedure EPF plic EPF plic NeedleNeedle

PU lig plic PU lig plic NeedleNeedle

EPF plic TVTEPF plic TVT

Follow-up (mo.)Follow-up (mo.) 6 mo6 mo 5 y5 y 2 y2 y

Cure rate of SUI Cure rate of SUI 93% vs 86%93% vs 86% 50% vs 76%50% vs 76% 56% vs 92%56% vs 92%

““de novo urge”de novo urge” 1% vs 14%1% vs 14% 4% vs 2%4% vs 2% 4% vs 12%4% vs 12%

Surgery for POP and SUISurgery for POP and SUIDo a sling later onDo a sling later on

Comparing TVT at the time of POP surgery and TVT 3 months later

Results on women randomized to receive TVT after POP surgery

• 92 women with urodynamic SUI, mostly clinical• 28% were cured following POP surgery• 72% still had SUI but 1 out of four denied to undergo TVT later on

Borstad et al, IUJ 2010Borstad et al, IUJ 2010

GroutzGroutz

20042004

YamadaYamada

20012001

BarnesBarnes

20022002

ChaikinChaikin

20002000

KlutkeKlutke

20002000

Patient numberPatient number 100100 1010 3838 1414 5555

Type of studyType of study ProspectProspect ProspectProspect RetrospectRetrospect ProspectProspect RetrospectRetrospect

ProcedureProcedure TVTTVT SU slingSU sling PV SlingPV Sling PV slingPV sling BurchBurch

Follow-up (mo.)Follow-up (mo.) 27 mo27 mo 51 mo51 mo 15 mo15 mo 47 mo47 mo 3-5 y3-5 y

Cure rate of SUICure rate of SUI 98%98% 99%99% 93%93% 86%86% 96%96%

““de novo urge”de novo urge” 8%8% 10%10% 9.5%9.5% 7%7% 30%30%

POP and occult urodynamic SUIPOP and occult urodynamic SUI Concomitant proceduresConcomitant procedures

The high rate of POSUI legitimates the choice of a systematic anti-SUI procedure

POP and SUI surgeryPOP and SUI surgery

• No clear evidence of increased rate of complications No clear evidence of increased rate of complications when compared with TVT alonewhen compared with TVT alone

• Prolapse surgery alone Prolapse surgery alone

Intraoperative complicationsIntraoperative complications

Postoperative voiding dysfunctionPostoperative voiding dysfunction

ComplicationsComplications

The risk of post-op retention equals the rate of POSUI• 7.5% of obstruction requiring surgery• 8.3% of POSUI requiring intervention

Ballert et al, 2009Ballert et al, 2009

ConclusionsConclusions

• Barrier tests have low sensitivity but patients with pre-op Barrier tests have low sensitivity but patients with pre-op

leakages are at higher risk to develop POSUI leakages are at higher risk to develop POSUI

• Urodynamics does not predict outcome or which procedure is Urodynamics does not predict outcome or which procedure is

needed. needed. It may be helpful for counselling patientsIt may be helpful for counselling patients

• There is no clear evidence that concomitant SUI surgery in There is no clear evidence that concomitant SUI surgery in

occult SUI should be performed as quite half of the patients occult SUI should be performed as quite half of the patients

are continent of urine after prolapse repair by itself.are continent of urine after prolapse repair by itself.

• POSUI might be considered as a unsucessfull treatment but POSUI might be considered as a unsucessfull treatment but

warn patients about increased intraoperative morbidity and warn patients about increased intraoperative morbidity and

voiding dysfunctionvoiding dysfunction