Bladder Training in Radical Prostatectomy

Study Overview
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Brief Summary
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Radical prostatectomy is the gold standard in the treatment of patients with localized prostate cancer. Urinary incontinence, which is common after surgery, can affect the quality of life of men negatively. There are various attempts to prevent and treat urinary symptoms after radical prostatectomy.The aim of this study is to evaluate the effect of the structured bladder training program on lower urinary tract symptoms and quality of life in patients undergoing radical prostatectomy.

Official Title
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The Effect of Structured Bladder Training Program on Lower Urinary System Symptoms and Quality of Life After Radical Prostatectomy

Conditions
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Urinary Incontinence, Quality of Life, Lower Urinary Tract Symptoms

Intervention / Treatment
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* Behavioral: Bladder Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being over the age of 40 years Being male Being with localized prostate cancer Undergoing open radical prostatectomy No preoperative urinary incontinence Being body mass index> 30 kg/m2 Agreeing to participate in the research Being literate Exclusion Criteria: Having a congenital disorder of the urinary system Having neurological disorders Having a history of transurethral resection of the prostate Having communication and mental impairment Inability to do pelvic floor muscle exercises

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bladder Training<br>Patients in the structured bladder training group were trained on lifestyle changes (nutrition, fluid management, exercise), pelvic floor muscle exercises and bladder control techniques. | Behavioral: Bladder Training<br>* Patients in the structured bladder training group were trained on lifestyle changes (nutrition, fluid management, exercise), pelvic floor muscle exercises and bladder control techniques.<br>|
| No Intervention: Control Group<br>Routine patient training was given to the patients in the control group by a nurse working in the clinic. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary incontinence-related quality of life assessed by the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) | The primary endpoint of this study was the difference between groups in terms of International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) scores 3 months after. This scale consists of 6 questions.The range of scores obtained from the scale varies between 0-21 points. High scores on the scale indicate that the quality of urinary incontinence is severely affected. | 3 months after from baseline (0 month) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower urinary tract symptoms assessed by the International Consultation on Incontinence Questionnaire-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) | The secondary endpoint is the difference between the groups in terms of International Consultation on Incontinence Questionnaire-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) scores after 3 months. This scale consists of 13 questions. Each question has a 4-point severity scale (0-4) and a 10-point visual analog scale (0-10) measuring quality of life. As the scores obtained from the scale increase, complaints about urinary system symptoms increase and the quality is negatively affected. | 3 months after from baseline (0 month) |