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CATH Trial

 

Gerandomiseerd vergelijk tussen een verblijfscatheter en intermitterend catheteriseren ter behandeling van een postoperatieve blaasretentie na vaginale prolapschirurgie

 

Go to the CATH website.

 

Objective:

After vaginal prolapse surgery urinary retention is the most frequently encountered complication. Applying long term initial catheterisation has shown to be unnecessary in the majority of cases. With a maximum of 24 hours of initial postoperative catheterisation the incidence of urinary catheterisation has shown to be acceptable (approximately 25%). No evidence exists about the risk factors for developing urinary retention after vaginal prolapse surgery. Furthermore, there is little evidence about the optimal treatment strategy for urinary retention in this group of patients.

The aim of this study is to determine potential predictors for the development of urinary retention and to determine the optimal treatment strategy when retention has occurred.

 

Study Design:

Multicentre prospective cohort study and multicentre prospective randomised controlled trial.

 

Study population:

All women requiring surgical correction for vaginal prolapse.  

 

Intervention:

Randomised comparison between an indwelling cather for the duration of three days and intermittent catheterisation with a maximum interval of 6 hours.

 

Outcome measures:

Total duration of catheterisation, hospitalisation, development of bacteriuria, patient satisfaction, cost effectiveness


Power/data analysis:

Based on the primary outcome measure total duration of catheterisation we find a resumption of normal voiding 12 hours earlier in the intermittent catheterisation group clinically significant. Based on a standard deviation of 0.6 days a total of 32 patients will be  randomised in each group (alpha 0.05, power 0.90).

 

Time schedule:

Total expected study time 12 months

 

Participating hospitals and projectmembers:

Spaarne Ziekenhuis Hoofddorp

Waterland Ziekenhuis Purmerend

Gelre Ziekenhuizen Apeldoorn,

Twee steden Ziekenhuis Tilburg

Maxima Medisch Centrum Veldhoven

Mesos Medisch Centrum Utrecht

Flevo ziekenhuis Almere

 

Projectleaders:

R.A. Hakvoort , Spaarne Ziekenhuis Hoofddorp 

Dr. J.P. Roovers, AMC Amsterdam

Dr. M.H. Emanuel, Spaarne Ziekenhuis Hoofddorp 

 

Subsidy:

None