Prostate CancerNCT03061760
Effects of Urinary Bladder Hypertrophy on Urge Urine Incontinence After Radical Prostatectomy
An observational study of Prostate Cancer and Urinary Incontinence, Urge, run by Collegium Medicum w Bydgoszczy.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 40 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Urinary Incontinence, Urge, Incontinence
- What is being tested?
- Radical prostatectomy, Initial evaluation and Evaluation after 1,3,6,9,12 months
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men with prostate cancer aged over 40 years old (usually 50-75) undergoing radical prostatectomy before the surgery and observed for 12 months. Control group formed from healthy volunteers aged 20-40 years.
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
Radical prostatectomy remains the standard treatment in case of organ-confined and in selected cases of locally advanced prostate cancer. Radical prostatectomy consists of removing the prostate gland and seminal vesicles, ideally with negative surgical margins.
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
- Prostate Cancer, Urinary Incontinence, Urge, Incontinence, Prostatectomy, Overactive Bladder
- Being tested
- Radical prostatectomy, Initial evaluation, Evaluation after 1,3,6,9,12 months
- Keywords
- Prostate cancer, Incontinence, Radical prostatectomy, Urge urinary incontinence
- Medical subject headings
- Prostatic Neoplasms, Urinary Incontinence, Urge, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical prostatectomyProcedure or surgery
Radical prostatectomy due to prostate cancer.
Initial evaluationDiagnostic test
Questioners, Ultrasound, Uroflowmetry
Evaluation after 1,3,6,9,12 monthsDiagnostic test
Questioners, Ultrasound, Uroflowmetry
| Study group | Role | What they receive |
|---|---|---|
| 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'. Receives: Procedure: Radical prostatectomy; Diagnostic Test: Initial evaluation; Diagnostic Test: Evaluation after 1,3,6,9,12 months | |
| 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'. Receives: Procedure: Radical prostatectomy; Diagnostic Test: Initial evaluation; Diagnostic Test: Evaluation after 1,3,6,9,12 months | |
| 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'. Receives: Procedure: Radical prostatectomy; Diagnostic Test: Initial evaluation; Diagnostic Test: Evaluation after 1,3,6,9,12 months | |
| 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'. Receives: Procedure: Radical prostatectomy; Diagnostic Test: Initial evaluation; Diagnostic Test: Evaluation after 1,3,6,9,12 months | |
| 5.Control group | Healthy volunteer individuals aged 20-40. 'Initial evaluation' made only once. Receives: Diagnostic Test: Initial evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
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.
Measured: 12 months
Secondary outcomes (6)
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.
Measured: 12 months
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.
Measured: 12 months.
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Mar 2017 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Collegium Medicum w Bydgoszczy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Drewa, Collegium Medicum w Bydgoszczy
- Investigators
- Tomasz A Drewa, Prof., Principal investigator, Collegium Medicum w Bydgoszczy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061760
- Sponsor's protocol ID
- CMBydgoszczy
- Status last verified
- Feb 2017
- First submitted
- 15 Feb 2017
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The summary of all the results will be provided on ClinicalTrials.gov . Individual patient data may be provided after individual request to the extant needed for the requesting researcher.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Could Urinary Bladder Hypertrophy Influence on Urge Urine Incontinence Development in Patients After Radical Prostatectomy: A Multi-center Study
- ClinicalTrials.gov ID
- NCT03061760
- Acronym / sponsor ID
- CMBydgoszczy
- Conditions
- Prostate Cancer, Urinary Incontinence, Urge, Incontinence, Prostatectomy, Overactive Bladder
- Keywords
- Prostate cancer, Incontinence, Radical prostatectomy, Urge urinary incontinence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Collegium Medicum w BydgoszczyUniversity, hospital or other
- Study start
- 1 Mar 2017 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Radical prostatectomy remains the standard treatment in case of organ-confined and in selected cases of locally advanced prostate cancer. Radical prostatectomy consists of removing the prostate gland and seminal vesicles, ideally with negative surgical margins.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1. OAB (-) BOO (-) | – | Procedure: Radical prostatectomy, Diagnostic Test: Initial evaluation, Diagnostic Test: Evaluation after 1,3,6,9,12 monthsPatients 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'. |
| 2. OAB (-) BOO (+) | – | Procedure: Radical prostatectomy, Diagnostic Test: Initial evaluation, Diagnostic Test: Evaluation after 1,3,6,9,12 monthsPatients 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'. |
| 3. OAB (+) BOO (+) | – | Procedure: Radical prostatectomy, Diagnostic Test: Initial evaluation, Diagnostic Test: Evaluation after 1,3,6,9,12 monthsPatients 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'. |
| 4.OAB (+) BOO (-) | – | Procedure: Radical prostatectomy, Diagnostic Test: Initial evaluation, Diagnostic Test: Evaluation after 1,3,6,9,12 monthsPatients 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'. |
| 5.Control group | – | Diagnostic Test: Initial evaluationHealthy volunteer individuals aged 20-40. 'Initial evaluation' made only once. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men with prostate cancer aged over 40 years old (usually 50-75) undergoing radical prostatectomy before the surgery and observed for 12 months. Control group formed from healthy volunteers aged 20-40 years.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radical prostatectomyRadical prostatectomy due to prostate cancer. | Procedure or surgery | 1. OAB (-) BOO (-), 2. OAB (-) BOO (+), 3. OAB (+) BOO (+), 4.OAB (+) BOO (-) |
| Initial evaluationQuestioners, Ultrasound, Uroflowmetry | Diagnostic test | 1. OAB (-) BOO (-), 2. OAB (-) BOO (+), 3. OAB (+) BOO (+), 4.OAB (+) BOO (-), 5.Control group |
| Evaluation after 1,3,6,9,12 monthsQuestioners, Ultrasound, Uroflowmetry | Diagnostic test | 1. OAB (-) BOO (-), 2. OAB (-) BOO (+), 3. OAB (+) BOO (+), 4.OAB (+) BOO (-) |
Primary outcome
Increased incidence OAB - Ultrasonography of bladder wall
Time frame: 12 months
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.
Increased incidence OAB - Questioners
Time frame: 12 months
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.
6 secondary outcomes
Continence
Time frame: 12 months
Qmax-Uroflowmetry
Time frame: 12 months.
Bladder volume during normal desire.
Time frame: 12 months
Quality of life.
Time frame: 12 months
Quality of urination.
Time frame: 12 months
Increased incidence OAB - Ultrasonography - Calculated Bladder weight
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: No. The summary of all the results will be provided on ClinicalTrials.gov . Individual patient data may be provided after individual request to the extant needed for the requesting researcher.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomasz A Drewa, Prof. principal investigator
Collegium Medicum w Bydgoszczy
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Urinary Incontinence, Urge, run by Collegium Medicum w Bydgoszczy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adam Ostrowski, MD (+48525854500, adostro@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increased incidence OAB - Ultrasonography of bladder wall (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.