1-objective: to get insight in objective (urodynamic) and subjective (questionnaire) changes of the lower urinary tract after laparoscopic robot assisted radical prostatectomy, Intensity modulated radiotherapy, I-125 brachytherapy.2-To create…
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Urodynamic changes in comparison with the baseline:
• Maximum flow rate
• Volume of the first muscle instability.
• Amplitude of the first instable contraction
• Amplitude of the maximal instable contraction
• Volume of the maximal instable contraction
• Volume of the first desire to urinate
• Bladder compliance before and after brachytherapie
• Maximale urethral closure pressure (MUCP)
• Urethrale pressure profile-length
• Urethrale resistance/URA_BOOI
• Schafer graad
• Bladder contractility index:PQmax+5xQmax, Wmax, WQmax
* Post-void residue
* 24 uur padtest
Secondary outcome
The subjetive changes of parameters in comparison with the baseline:
International Prostate Symptom Score (IPSS)
• Frequentie- volume Chart
• EPIC-MICTURATION
• EPIC-INTESTINAL SYMPTOMS
• EPIC-SEXUALITY
Background summary
The treatment of organ confined prostate cancer is radical
prostatecomy/external beam radiotherapy or I-125 brachytherapy.In umc utrecht
we offer Laparoscopic robot assisted radical prostatectomy, Intensity modulated
radiotherapy, I-125 brachytherapy.
Each modality has its own complication profile.
The objective effects of these modalities have never prospectively been
studied. The complication profile of each modality plays an important role in
the therapy decision making process. The choice of therapeutic modality is
often based on guidlines and less based on evidence in the literatuur.
This research makes it possible(Theoretically) to recognize the patient at risk
of complication. To create a selection criteria and to tailored an adequate
treatment for the patient with locally confined prostate cancer a prospective
study on the (objective and subjective)effects of each therapy on urinary tract
is a justified.
Study objective
1-objective: to get insight in objective (urodynamic) and subjective
(questionnaire) changes of the lower urinary tract after laparoscopic robot
assisted radical prostatectomy, Intensity modulated radiotherapy, I-125
brachytherapy.
2-To create selection criteria to tailored an adequate treatment option for the
patient with locally confined prostate cancer.
Study design
An observational, prospective cohort research on functional effects of
different therapeutic modalities of locally confined prostate cancer on lower
urinary tract.
Study burden and risks
Urodynamic study of the lower urinary tract is fairly comparable with inserting
catheter. It may result in lower urinary tract infection. This may occur in 2%
of patients ondergoing this test. To reduce the chance of infection, the
patients with high risk will be profylactically treated with antibiotics.
Heidelberglaan 100
3584 CX
Nederland
Heidelberglaan 100
3584 CX
Nederland
Listed location countries
Age
Inclusion criteria
Proven organ confined prostate cancer with indication for curative treatment
Exclusion criteria
(locally) advanced prostaat carcinoom
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL17075.041.07 |