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Clinical Trials/NCT04628351
NCT04628351CompletedNot Applicable

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

Saglik Bilimleri Universitesi1 site in 1 country60 target enrollmentStarted: October 10, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Urinary incontinence-related quality of life assessed by the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
40 Years to 85 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Bladder Training

Experimental

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

Intervention: Bladder Training (Behavioral)

Control Group

No Intervention

Routine patient training was given to the patients in the control group by a nurse working in the clinic.

Outcomes

Primary Outcomes

Urinary incontinence-related quality of life assessed by the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)

Time Frame: 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 Outcomes

  • 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))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Elif Gezginci

RN, PHD, Asst Prof

Saglik Bilimleri Universitesi

Study Sites (1)

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