Prostate Cancer Clinical Trial
Official title:
Could Urinary Bladder Hypertrophy Influence on Urge Urine Incontinence Development in Patients After Radical Prostatectomy: A Multi-center Study
This study is designed to evaluate men before radical prostatectomy for the incidence of Overactive Bladder (OAB), as well as urge urine incontinence (UUI) development after the surgery. Patients will be evaluated for signs of OAB and for signs of Bladder Outlet Obstruction (BOO). Afterwards they will be divided into four observational groups. Follow up period is designed to be 12 months.
Status | Not yet recruiting |
Enrollment | 250 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - Adult men over 40 years old with prostate cancer qualified for radical prostatectomy - 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: - Neoadjuvant (any time before) or adjuvant radiotherapy or brachytherapy (within the follow-up period of 12 months). - 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). |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Collegium Medicum w Bydgoszczy |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Increased incidence OAB - Ultrasonography of bladder wall | Measuring the incidence of overactive bladder and urge urinary incontinence development after radical prostatectomy in patients - characterized by increased urinary wall thickness (changes of urinary bladder wall in ultrasound evaluation measured in sagittal section in millimeters). Measurement: Bladder wall thickness, Detrusor Muscle thickness on each follow up visit. |
12 months | |
Primary | Increased incidence OAB - Questioners | Measuring the incidence of symptoms of overactive bladder and urge urinary incontinence development after radical prostatectomy in patients - characterized by changes found in OABSS survey (Questioners). Measurement: OABSS survey on each follow up visit. |
12 months | |
Secondary | Continence | Defined as number of pads used per day during the follow up period. Measurement: Number of pads, that patient claims he is using per day at the moment of each follow up visit. |
12 months | |
Secondary | Qmax-Uroflowmetry | The change of Maximal urine flow in the uroflowmetry test is a good predictor of the quality of urination. The change in Qmax will be observed after radical prostatectomy. Measurement: Uroflowmetry on each follow up visit. |
12 months. | |
Secondary | Bladder volume during normal desire. | This outcome is designed to check whether and to what extent bladder volume (decreased) influences the development of OAB, worsens the continence and affects quality of life (QoL). Measurement: Ultrasound measuring bladder capacity during normal desire on each follow up visit. |
12 months | |
Secondary | Quality of life. | This outcome is designed to check how much incontinence and development of OAB affects the quality of life. King's Quality of Life Questioner will be assessed during each follow up visit. Measurement: King's Quality of Life Questioner on each follow up visit. |
12 months | |
Secondary | Quality of urination. | This outcome is designed to check how much the surgery affects the quality of urination itself. IPSS questioner will be assessed during each follow up visit. Measurement: IPSS on each follow up visit. |
12 months | |
Secondary | Increased incidence OAB - Ultrasonography - Calculated Bladder weight | Measuring the incidence of overactive bladder and urge urinary incontinence development after radical prostatectomy in patients - characterized by calculated bladder weight (changes of calculated bladder weight in grams). Measurement: Calculated Bladder weight on each follow up visit. |
12 months |
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