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Stefano Salvatore Obstetrics and Gynaecology Unit, Functional Unit of Urogynaecology, Vita-Salute San Raffaele University and IRRCS San Raffaele Hospital, Milan, Italy URODINAMIC STUDY BEFORE SURGERY FOR STRESS URINARY INCONTINENCE

Urodinamic study before surgery for stress urinary incontinence

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Stefano Salvatore

Obstetrics and Gynaecology Unit, Functional Unit of Urogynaecology, Vita-Salute San Raffaele University and

IRRCS San Raffaele Hospital, Milan, Italy

URODINAMIC STUDY BEFORE SURGERY

FOR STRESS URINARY INCONTINENCE

URODINAMIC STUDY BEFORE SURGERY FOR STRESS URINARY INCONTINENCE

Obstetrics and Gynaecology Unit, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan, Italy

• 2010 - 2014 search• Keywords

– Urodynamics– Surgery/treatment– Stress incontinence

• Advances search– RCTs– Clinical trials– Review– Guideline

URODINAMIC STUDY BEFORE SURGERY FOR STRESS URINARY INCONTINENCE

Obstetrics and Gynaecology Unit, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan, Italy

• Non-inferiority RCT involving women with SUI to compare:– outcomes after preoperative office evaluation only– and UDS

A randomized trial of urodynamic testing before stress-incontinence surgery.

Nager CW, et al. Urinary IncontinenceTreatment Network. 2012

• Success rate was 77.2% in the urodynamic-testing group versus 78.9% in the evaluation-only group

URODINAMIC STUDY BEFORE SURGERY FOR STRESS URINARY INCONTINENCE

Obstetrics and Gynaecology Unit, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan, Italy

No significant between-group differences in: – secondary measures of incontinence

severity – quality of life– patient satisfaction – rates of positive provocative stress

tests – voiding dysfunction– or adverse events

URODINAMIC STUDY BEFORE SURGERY FOR STRESS URINARY INCONTINENCE

Obstetrics and Gynaecology Unit, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan, Italy

Finazzi-Agrò E, Serati M, Salvatore S, Del Popolo G.

• Conclusive analysis performed only on 523 of the initially screened 4083 female patients (less than 13%)

• The two study arms were imbalanced for: – duration and severity of symptoms, – previous treatment of incontinence, – absence of estrogen therapy, – and urethral hypermobility.

URODINAMIC STUDY BEFORE SURGERY FOR STRESS URINARY INCONTINENCE

Obstetrics and Gynaecology Unit, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan, Italy

• Multicenter non-inferiority RCT: Women with SUI were randomized to management based on a workup with or without UDS

• The trial stopped prematurely because of slow recruitment: randomly allocated 59 women to a strategy with (N = 31) or without (N = 28) UDS.

• The mean difference in improvement on the UDI-UI was 14 in favor of the group without UDS

• Addition of UDS did not result in a lower occurrence of de novo OAB

URODINAMIC STUDY BEFORE SURGERY FOR STRESS URINARY INCONTINENCE

Obstetrics and Gynaecology Unit, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan, Italy

• To estimate whether a strategy of immediate surgery was non-inferior to a strategy based on discordant UDS findings followed by individually tailored therapy in women with SUI

• A multicenter diagnostic non-inferiority RCT was carried out in 6 academic and 24 non academic Dutch hospitals.

• 578 women studied of whom – 268 (46%) had discordant findings– 126 gave consent and randomized to immediate surgery (64) or individually tailored therapy

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URODINAMIC STUDY BEFORE SURGERY FOR STRESS URINARY INCONTINENCE

Obstetrics and Gynaecology Unit, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan, Italy

• Immediate surgery is non-inferior to individually tailored treatment based on UDS

• UDS should no longer be advised routinely

Conclusion

URODINAMIC STUDY BEFORE SURGERY FOR STRESS URINARY INCONTINENCE

Obstetrics and Gynaecology Unit, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan, Italy

• Immediate surgery is non-inferior to individually tailored treatment based on UDS

• UDS should no longer be advised routinelyBUT

Conclusion

• The choice of sling in the surgery group was based on UDS parameters (MUCP and VLPP)

• DO was associated with an impaired postoperative cure

URODINAMIC STUDY BEFORE SURGERY FOR STRESS URINARY INCONTINENCE

Obstetrics and Gynaecology Unit, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan, Italy

The objective of this review was to assess whether the

performance of urodynamics altered the outcomes of cure or

complications in women undergoing surgery with isolated SUI or

stress-predominant MUI symptoms

Rachaneni and Latthe, BJOG, 2014

URODINAMIC STUDY BEFORE SURGERY FOR STRESS URINARY INCONTINENCE

Obstetrics and Gynaecology Unit, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan, Italy

Rachaneni and Latthe, BJOG, 2014

URODINAMIC STUDY BEFORE SURGERY FOR STRESS URINARY INCONTINENCE

Obstetrics and Gynaecology Unit, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan, Italy

Rachaneni and Latthe, BJOG, 2014

In women undergoing primary surgery for SUI or stress-

predominant MUI without voiding difficulties,

urodynamics does not improve outcomes – as long as

the women undergo careful office evaluation

URODINAMIC STUDY BEFORE SURGERY FOR STRESS URINARY INCONTINENCE

Obstetrics and Gynaecology Unit, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan, Italy

• To determine if pre-operative urodynamic testing (UDS) affects physicians’ diagnostic confidence and if physician confidence affects treatment outcomes at 1 year

• After office evaluation, physicians completed a checklist of five clinical diagnoses: SUI, OAB wet and dry, voiding dysfunction and ISD, and reported their confidence in each

• Responses ranged from 1 to 5 with; 1: ‘‘not very confident’’ to 5: ‘‘extremely confident”

• After UDS, investigators again rated their confidence in these five clinical diagnoses

URODINAMIC STUDY BEFORE SURGERY FOR STRESS URINARY INCONTINENCE

Obstetrics and Gynaecology Unit, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan, Italy

Confidence improved after UDS in patients with baseline SUI (4.52–4.63, P < 0.005), OAB-wet (3.55–3.75, P < 0.001), OAB-dry (3.55–3.68 P < 0.005), VD (3.81–3.95, P < 0.005), and suspected ISD (3.63–3.92, P < 0.001)

URODINAMIC STUDY BEFORE SURGERY FOR STRESS URINARY INCONTINENCE

Obstetrics and Gynaecology Unit, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan, Italy

Increased confidence after UDS was not associated with higher odds of treatment success although mean changes in confidence were slightly higher for those who achieved treatment success

URODINAMIC STUDY BEFORE SURGERY FOR STRESS URINARY INCONTINENCE

Obstetrics and Gynaecology Unit, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan, Italy

• Influence of preoperative UDS studies on – diagnoses, – global treatment plans – and outcomes

in women treated with surgery for uncomplicated predominant SUI• Secondary analysis from a multicenter RCT of the value of

preoperative UDS studies

Sirls et al., J Urol, 2013

URODINAMIC STUDY BEFORE SURGERY FOR STRESS URINARY INCONTINENCE

Obstetrics and Gynaecology Unit, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan, Italy

Sirls et al., J Urol, 2013

• UDS changed – the office evaluation in 167 women (56.8%),

• decreased the diagnoses of:– OAB-wet (41.6% to 25.2%, p <0.001) – OAB-dry (31.4% to 20.8%, p= 0.002) – and intrinsic sphincter deficiency (19.4% to 12.6%, p = 0.003)

• increased the diagnosis of voiding dysfunction (2.2% to 11.9%, p <0.001)

URODINAMIC STUDY BEFORE SURGERY FOR STRESS URINARY INCONTINENCE

Obstetrics and Gynaecology Unit, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan, Italy

Sirls et al., J Urol, 2013

• After UDS physicians

– canceled surgery in 4 of 294 women (1.4%),

– changed the incontinence procedure in 13 (4.4%)

– planned to modify mid urethral sling tension (more or less obstructive) in 20 women (6.8%).

– Non operative tx plans changed in 40 of 294 women (14%).

URODINAMIC STUDY BEFORE SURGERY FOR STRESS URINARY INCONTINENCE

Obstetrics and Gynaecology Unit, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan, Italy

• In 263 women with pure SUI to identify – how many pts with pure SUI do not require any surgical treatment on the basis of UDS

and – how many pts still do not require surgery 1 year after UDS. – To assess the outcomes of these pts at 12-month follow-up.

• UDS showed that 18.6% pts with pure SUI present DO and 80% of them do not require surgery, even 1 year after UDS

• In these pts antimuscarinics appear to ensure a good cure rate

URODINAMIC STUDY BEFORE SURGERY FOR STRESS URINARY INCONTINENCE

Obstetrics and Gynaecology Unit, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan, Italy

At the level of specialised management (when primarytherapy failed, diagnosis is unclear, or symptoms and/orsigns are complex/severe), more elaborate assessmentis generally required, including imaging, endoscopy, andurodynamics

EAU guidelines on urinary incontinence

URODINAMIC STUDY BEFORE SURGERY FOR STRESS URINARY INCONTINENCE

Obstetrics and Gynaecology Unit, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan, Italy

URODINAMIC STUDY BEFORE SURGERY FOR STRESS URINARY INCONTINENCE

Obstetrics and Gynaecology Unit, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan, Italy

The people who do accurate simple clinical assessments are those who have gained extensive insight into LUTS-dysfunction by previously performing sophisticated

multichannel urodynamic studies

Paul Abrams Am J Obstet Gynecol 1994; 171:1472-9

URODINAMIC STUDY BEFORE SURGERY FOR STRESS URINARY INCONTINENCE

Obstetrics and Gynaecology Unit, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan, Italy

Take Home Messages

• Curious that all studies questioning UDS comes from Gynae Units

• Definition of success should not be focused just on SUI but include LUTS in general

• Exclusive office work-up might be limited to a very restricted group of pts although not entirely supported by complete clinical evidence

URODINAMIC STUDY BEFORE SURGERY FOR STRESS URINARY INCONTINENCE

Obstetrics and Gynaecology Unit, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan, Italy

GRAZIE