Effects of Urinary Bladder Hypertrophy on Urge Urine Incontinence After Radical Prostatectomy

• Conditions: Prostatectomy; Prostate Cancer; Incontinence; Urinary Incontinence, Urge; Overactive Bladder
• Interventions: Procedure: Radical prostatectomy; Diagnostic Test: Initial evaluation; Diagnostic Test: Evaluation after 1,3,6,9,12 months

• Registration Number: NCT03061760
• Lead Sponsor: Collegium Medicum w Bydgoszczy

Brief 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). 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 Timeline

• Status Verified: 2017-02
• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-02-21
• Last Update Submitted: 2017-02-21
• Study First Posted: 2017-02-23
• Last Update Posted: 2017-02-23
• Study Start: 2017-03-01
• Primary Completion: 2018-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 250

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1. OAB (-) BOO (-)	Radical prostatectomy	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'.
4.OAB (+) BOO (-)	Initial evaluation	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'.
4.OAB (+) BOO (-)	Radical prostatectomy	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'.
1. OAB (-) BOO (-)	Initial evaluation	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'.
1. OAB (-) BOO (-)	Evaluation after 1,3,6,9,12 months	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'.
3. OAB (+) BOO (+)	Radical prostatectomy	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'.
3. OAB (+) BOO (+)	Evaluation after 1,3,6,9,12 months	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'.
2. OAB (-) BOO (+)	Radical prostatectomy	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'.
2. OAB (-) BOO (+)	Initial evaluation	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'.
2. OAB (-) BOO (+)	Evaluation after 1,3,6,9,12 months	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'.
3. OAB (+) BOO (+)	Initial evaluation	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'.
4.OAB (+) BOO (-)	Evaluation after 1,3,6,9,12 months	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'.
5.Control group	Initial evaluation	Healthy volunteer individuals aged 20-40. 'Initial evaluation' made only once.

Primary Outcome Measures

Name	Time	Method
Increased incidence OAB - Ultrasonography of bladder wall	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	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.

Secondary Outcome Measures

Name	Time	Method
Continence	12 months	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.
Qmax-Uroflowmetry	12 months.	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.
Bladder volume during normal desire.	12 months	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.
Quality of life.	12 months	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.
Quality of urination.	12 months	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.
Increased incidence OAB - Ultrasonography - Calculated Bladder weight	12 months	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.