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VUSIS-I

 

Value of Urodynamics prior to Stress Incontinence Surgery

 

Go to the Vusis page.

 

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. 

  

OBJECTIVE:

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.

 

STUDY DESIGN:

Multicentre prospective randomised controlled multidisciplinary trial.

 

STUDY POPULATION:

Women with symptomatic stress urinary incontinence in whom conservative measures failed and in whom surgical treatment is considered.

 

INTERVENTION:

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.

 

OUTCOME MEASURES:

Primary outcome: Non inferiority of the improvement of the Urinary Distress Inventory (UDI) two years after treatment in the non urodynamics group.
Secondary outcomes: Cure of incontinence as measured with pad test and voiding diary. Complications of surgery for stress incontinence in particular re-operation and overactive bladder symptoms of quality of life as measured by validated questionnaires.

 

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.

 

ECONOMIC EVALUATION:

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.

 

TIME-SCHEDULE:

Start inclusion march 2007. Inclusion period 12 months. Follow up 24 months.

 

PROJECTLEADER:

M.E. Vierhout, MD, PhD, Dept. of Gynaecology, UMC St Radboud

J.P.F.A. Heesakkers, MD, PhD, Dept. of Urology UMC St Radboud

 

STUDY COORDINATOR:

Sanne van Leijsen, MD, Dept. of Gynecology, UMC St. Radboud

 

METHODOLOGY:

J.C.M. Hendriks, PhD, Dept. of Epidemiology UMC St Radboud

 

PARTICIPATING HOSPITALS:

UMC St Radboud, Nijmegen

Ziekenhuis Rijnstate, Arnhem

Ziekenhuis Zevenaar, Zevenaar

Ziekenhuis Gelderse Vallei, Ede

Slingeland Ziekenhuis, Doetinchem

Catharina-Ziekenhuis, Eindhoven

Laurentius Ziekenhuis, Roermond

St.Elisabeth Ziekenhuis, Tilburg

Academisch Medisch Centrum, Amsterdam

Maxima Medisch Centrum, Veldhoven

Alant Vrouw, Bilthoven

Fransiscus Ziekenhuis, Roosendaal

Stichting Lievensberg ziekenhuis, Bergen op Zoom

Canisius-Wilhelmina Ziekenhuis, Nijmegen

Ikazia Ziekenhuis, Rotterdam

Meander Medisch Centrum, Amersfoort

Reinier de Graaf Groep, Delft

Gelre ziekenhuis, Apeldoorn

VieCuri Medisch Centrum, Venlo

 

CONTACT:

Sanne van Leijsen, arts-onderzoeker
UMC St Radboud Nijmegen

St Antonius Ziekenhuis Nieuwegein
Tel: 030-609 9111 pieper 839
Mobiel: 06-41520114
E-mail:
sannevanleijsen@hotmail.com