Clinical trial NCT03061760: Effects of Urinary Bladder Hypertrophy on Urge Urine Incontinence After Radical Prostatectomy
Official title: Could Urinary Bladder Hypertrophy Influence on Urge Urine Incontinence Development in Patients After Radical Prostatectomy: A Multi-center Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Urinary Incontinence, Urge
Incontinence
Prostatectomy
Overactive Bladder
Keywords: Prostate cancer
Incontinence
Radical prostatectomy
Urge urinary incontinence
Lead sponsor: Collegium Medicum w Bydgoszczy
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 250
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Increased incidence OAB - Ultrasonography of bladder wall
timeFrame: 12 months
measure: Increased incidence OAB - Questioners
timeFrame: 12 months
Secondary outcomes:
measure: Continence
timeFrame: 12 months
measure: Qmax-Uroflowmetry
timeFrame: 12 months.
measure: Bladder volume during normal desire.
timeFrame: 12 months
measure: Quality of life.
timeFrame: 12 months
measure: Quality of urination.
timeFrame: 12 months
measure: Increased incidence OAB - Ultrasonography - Calculated Bladder weight
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Collegium Medicum w Bydgoszczy
name: Tomasz A Drewa, Prof.
role: PRINCIPAL_INVESTIGATOR
References: