Bladder Training in Radical Prostatectomy

Not Applicable

Completed

• Conditions: Urinary Incontinence; Quality of Life; Lower Urinary Tract Symptoms
• Interventions: Behavioral: Bladder Training

• Registration Number: NCT04628351
• Lead Sponsor: Saglik Bilimleri Universitesi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-10
• Primary Completion: 2020-03-10
• Status Verified: 2020-11
• Study Completion: 2020-11-07
• Study First Submitted: 2020-11-07
• Study First Submitted QC: 2020-11-07
• Study First Posted: 2020-11-13
• Last Update Submitted: 2020-11-13
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bladder Training	Bladder Training	Patients in the structured bladder training group were trained on "lifestyle changes (nutrition, fluid management, exercise), pelvic floor muscle exercises and bladder control techniques".

Primary Outcome Measures

Name	Time	Method
Urinary incontinence-related quality of life assessed by the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)	3 months after from baseline (0 month)	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.

Secondary Outcome Measures

Name	Time	Method
Lower urinary tract symptoms assessed by the International Consultation on Incontinence Questionnaire-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)	3 months after from baseline (0 month)	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.

Trial Locations

Locations (1)

Elif Gezginci; 🇹🇷 Istanbul, Turkey