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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