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GALAPAGOZ

 

Grading quAlity of Life And Pelvic floor function after treAtment of Gynaecologic Oncological disease and helpSeeking behaviour

 

Objective

Can pelvic physiotherapy improve bladder function and pelvic floor related quality of life after radical hysterectomy for cervical cancer.

 

Study design

Randomised controlled trial

 

Study population

All women who will undergo a radical hysterectomy and lymph-adenectomy for cervical cancer, who never had bladder or bowl surgery

 

Interventions

Pelvic physiotherapy in combination with written information about pelvic floor behaviour versus written information only.

 

Outcome measures

Primary outcome:

Pelvic floor related quality of life

Secondary outcome:

General quality of life

Bladder function

Provided hours of physiotherapy additional to the standard intervention

Health care consumption for pelvic floor problems in the first year after radical hysterectomy

 

Power / data analysis

Based on mean domain scores of a population and patient based sample we considered the obstructive micturition domain to be the most important outcome measurement. We consider a difference of 6 points in the domain score between both treatment groups to be clinical relevant. With a power of 80%, level of 0.05 and standard deviation of 9, the calculated sample size is 36 in each group.

 

Time schedule

Inclusion, September 2007 until September 2009, follow-up 12 months

 

Participating hospitals

Academic Medical Center (AMC) , Amsterdam

Other hospitals are very welcome to participate in this trial.

 

Projectleaders

M.H. Hazewinkel, AMC, Amsterdam

Dr J.P. Roovers, AMC, Amsterdam

Dr. M.R. Buist, AMC, Amsterdam

 

Subsidy

None