Effects of Urinary Bladder Hypertrophy on Urge Urine Incontinence After Radical Prostatectomy
NCT ID: NCT03061760
Last Updated: 2017-02-23
Study Results
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Basic Information
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UNKNOWN
250 participants
OBSERVATIONAL
2017-03-01
2019-12-31
Brief Summary
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Detailed Description
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Most of the patients who present urinary incontinence after radical prostatectomy have stress urinary incontinence. However in some cases the post-surgical urinary incontinence is also due to urgency caused by overactive bladder development defined as urge urinary incontinence. Recent clinical observations suggest that men can also develop overactive bladder after radical prostatectomy.
This study is designed to evaluate men before radical prostatectomy for the incidence of Overactive Bladder (OAB) and it's development after the surgery. Before surgery questionnaire assessment of lower urinary tract symptoms will be performed using International Prostate Symptom Score (IPSS) questionnaire. OAB symptoms will be analyzed using King's questionnaire, as well as using two different OAB symptom score (OABSS) designed by Blavis et al. and Homma et al. Each patient will have transabdominal ultrasonographic evaluation of the prostate and urinary bladder structure. Prostatic dimensions width (W), height (H), length (L) and volume will be recorded. The ultrasonography will be done in urinary bladder filling related to normal desire to void. Urinary bladder wall thickness (BWT) and detrusor muscle thickness (DWT) will be measured in sagittal plane in anterior bladder wall. The mean of three following measurements BWT and DWT will be obtained. The urinary bladder weight (UEBW: Ultrasound Estimated Bladder Weight) will be also estimated. After ultrasonography each patient will undergo uroflowmetry with post-void residual estimation.
On the results above 4 groups will be formed
Group 1 OAB (-) BOO (-)
Group 2 OAB (-) BOO (+)
Group 3 OAB (+) BOO (+)
Group 4 OAB (+) BOO (-)
The investigators will obtain detail information about the surgery (time, blood loss, histopathological outcome, nerve sparing, complications).
After the initial evaluation of the patients before surgery, the control evaluation is set on 1, 3, 6, 9, and 12 month after radical prostatectomy in groups 1-4 to define the lower urinary tract symptoms after radical prostatectomy related to pre-surgical patient clinical feature. During each of the following controls the investigator will not have the access to previously obtained data from the patient.
In addition, healthy volunteers aged 20 to 40 will be assigned as a control group.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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1. OAB (-) BOO (-)
Patients diagnosed with prostate cancer, undergoing radical prostatectomy, with no overactive bladder (OAB) symptoms and without bladder outlet obstruction (BOO). 'Initial evaluation' before the surgery and follow up - 'Evaluation after 1,3,6,9,12 months'.
Radical prostatectomy
Radical prostatectomy due to prostate cancer.
Initial evaluation
Questioners, Ultrasound, Uroflowmetry
Evaluation after 1,3,6,9,12 months
Questioners, Ultrasound, Uroflowmetry
2. OAB (-) BOO (+)
Patients diagnosed with prostate cancer, undergoing radical prostatectomy, with no overactive bladder (OAB) symptoms and with bladder outlet obstruction (BOO). 'Initial evaluation' before the surgery and follow up - 'Evaluation after 1,3,6,9,12 months'.
Radical prostatectomy
Radical prostatectomy due to prostate cancer.
Initial evaluation
Questioners, Ultrasound, Uroflowmetry
Evaluation after 1,3,6,9,12 months
Questioners, Ultrasound, Uroflowmetry
3. OAB (+) BOO (+)
Patients diagnosed with prostate cancer, undergoing radical prostatectomy, with overactive bladder (OAB) symptoms and with bladder outlet obstruction (BOO). 'Initial evaluation' before the surgery and follow up - 'Evaluation after 1,3,6,9,12 months'.
Radical prostatectomy
Radical prostatectomy due to prostate cancer.
Initial evaluation
Questioners, Ultrasound, Uroflowmetry
Evaluation after 1,3,6,9,12 months
Questioners, Ultrasound, Uroflowmetry
4.OAB (+) BOO (-)
Patients diagnosed with prostate cancer, undergoing radical prostatectomy, with overactive bladder (OAB) symptoms and without bladder outlet obstruction (BOO). 'Initial evaluation' before the surgery and follow up - 'Evaluation after 1,3,6,9,12 months'.
Radical prostatectomy
Radical prostatectomy due to prostate cancer.
Initial evaluation
Questioners, Ultrasound, Uroflowmetry
Evaluation after 1,3,6,9,12 months
Questioners, Ultrasound, Uroflowmetry
5.Control group
Healthy volunteer individuals aged 20-40. 'Initial evaluation' made only once.
Initial evaluation
Questioners, Ultrasound, Uroflowmetry
Interventions
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Radical prostatectomy
Radical prostatectomy due to prostate cancer.
Initial evaluation
Questioners, Ultrasound, Uroflowmetry
Evaluation after 1,3,6,9,12 months
Questioners, Ultrasound, Uroflowmetry
Eligibility Criteria
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Inclusion Criteria
* Control group formed from 20 healthy men aged 20-40 years old without any urological conditions and no lower urinary tract symptoms (LUTS).
Exclusion Criteria
* Macroscopic infiltration of the bladder (pT4).
* Neurological deficiencies, such as stroke, spinal cord injury, multiple sclerosis etc. causing inability to have any control of the bladder.
* Urethral strictures.
* Transurethral resection of the prostate or Adenomectomy performed within 12 months prior to Radical Prostatectomy.
* Any form of constant catheterisation (indwelling catheter, clean intermittent catheterisation).
40 Years
MALE
Yes
Sponsors
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Collegium Medicum w Bydgoszczy
OTHER
Responsible Party
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Tomasz Drewa
Prof. dr hab. n. med.
Principal Investigators
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Tomasz A Drewa, Prof.
Role: PRINCIPAL_INVESTIGATOR
Collegium Medicum w Bydgoszczy
Central Contacts
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Other Identifiers
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CMBydgoszczy
Identifier Type: -
Identifier Source: org_study_id
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