Bladder Training in Radical Prostatectomy

Sponsor
Saglik Bilimleri Universitesi (Other)
Overall Status
Completed
CT.gov ID
NCT04628351
Collaborator
(none)
60
1
2
12.9
4.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Bladder Training
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Structured Bladder Training Program on Lower Urinary System Symptoms and Quality of Life After Radical Prostatectomy
Actual Study Start Date :
Oct 10, 2019
Actual Primary Completion Date :
Mar 10, 2020
Actual Study Completion Date :
Nov 7, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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".

Behavioral: 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".

No Intervention: Control Group

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 85 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Elif Gezginci Istanbul Turkey

Sponsors and Collaborators

  • Saglik Bilimleri Universitesi

Investigators

  • Principal Investigator: Elif Gezginci, RN, PhD, Saglik Bilimleri Üniversitesi

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Elif Gezginci, RN, PHD, Asst Prof, Saglik Bilimleri Universitesi
ClinicalTrials.gov Identifier:
NCT04628351
Other Study ID Numbers:
  • 19/37
First Posted:
Nov 13, 2020
Last Update Posted:
Nov 17, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 17, 2020