Value of Urodynamics prior to Stress Incontinence Surgery
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Results: we randomly allocated 59 women to the two groups (28 without urodynamics, 31 with urodynamics). The mean improvement on the subscale urinary incontinence showed no difference between the groups after one year. The group without urodynamics was more likely to receive surgical management primarily (RR 1.15 95% CI 0.97-1.36). The total subjective cure rate of urinary incontinence (subscale score 0) was higher in the group without urodynamics (RR 1.36 95% CI 0.97-1.36). Omission of urodynamics did not result in a higher occurrence of de novo overactive bladder complaints (RR 0.22 95% CI 0.03-1.72).
Conclusions: The addition of urodynamics did not change the outcome of treatment in women with SUI. Cure rates are high and comparable to literature. Omission of urodynamics resulted in a higher rate of surgical interventions and higher subjective cure rates. Unfortunately, the inclusion proved to be difficult which limits the strength of our findings.
To test the value of preoperatively performed urodynamics with regard to outcome of surgery for stress urinary incontinence (SUI) and to examine whether not performing urodynamics preoperatively is more cost effective than performing urodynamics preoperatively using the non-inferiority assumption.
Multicentre prospective randomised controlled multidisciplinary trial.
Women with symptomatic stress urinary incontinence in whom conservative measures failed and in whom surgical treatment is considered.
Stress urinary incontinence therapy based on history, clinical examination, pad test and 48h voiding diary versus therapy based on the same parameters AND urodynamic findings.
Primary outcome: Non inferiority of the improvement of the Urinary Distress Inventory (UDI) two years after treatment in the non urodynamics group.
POWER / DATA ANALYSIS:
The mean improvement in UDI in both groups is expected to be 35 with standard deviation 10. A difference in mean improvement of 8 or less is considered non-inferior. 130 Women in each group are needed to reach a power of 70% using one-sided testing at 0.05. With a drop-out rate of 10% 145 women in each arm of the study are needed. A total of 290 women will be included in this study.
For each patient, utilisation of health care services will be recorded prospectively, including urodynamic testing, surgery for SUI, re-operations, medical treatment for detrusor instability, care for urinary incontinence, and care for urinary retention.
Start inclusion march 2007. Inclusion period 12 months. Follow up 24 months.
M.E. Vierhout, MD, PhD, Dept. of Gynaecology, UMC St Radboud
J.P.F.A. Heesakkers, MD, PhD, Dept. of Urology UMC St Radboud
Sanne van Leijsen, MD, Dept. of Gynecology, UMC St. Radboud
J.C.M. Hendriks, PhD, Dept. of Epidemiology UMC St Radboud
UMC St Radboud, Nijmegen
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Alant Vrouw, Bilthoven
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Canisius-Wilhelmina Ziekenhuis, Nijmegen
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VieCuri Medisch Centrum, Venlo
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St Antonius Ziekenhuis Nieuwegein