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Bladder Training in Radical Prostatectomy

Primary Purpose

Urinary Incontinence, Quality of Life, Lower Urinary Tract Symptoms

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bladder Training
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Urinary Incontinence

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Elif Gezginci

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Bladder Training

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 7, 2020
Last Updated
November 13, 2020
Sponsor
Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT04628351
Brief Title
Bladder Training in Radical Prostatectomy
Official Title
The Effect of Structured Bladder Training Program on Lower Urinary System Symptoms and Quality of Life After Radical Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
March 10, 2020 (Actual)
Study Completion Date
November 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Quality of Life, Lower Urinary Tract Symptoms

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bladder Training
Arm Type
Experimental
Arm Description
Patients in the structured bladder training group were trained on "lifestyle changes (nutrition, fluid management, exercise), pelvic floor muscle exercises and bladder control techniques".
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Routine patient training was given to the patients in the control group by a nurse working in the clinic.
Intervention Type
Behavioral
Intervention Name(s)
Bladder Training
Intervention Description
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 Measure Information:
Title
Urinary incontinence-related quality of life assessed by the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
Description
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.
Time Frame
3 months after from baseline (0 month)
Secondary Outcome Measure Information:
Title
Lower urinary tract symptoms assessed by the International Consultation on Incontinence Questionnaire-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)
Description
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.
Time Frame
3 months after from baseline (0 month)

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Gezginci, RN, PhD
Organizational Affiliation
Saglik Bilimleri Üniversitesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Elif Gezginci
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22332815
Citation
Tienforti D, Sacco E, Marangi F, D'Addessi A, Racioppi M, Gulino G, Pinto F, Totaro A, D'Agostino D, Bassi P. Efficacy of an assisted low-intensity programme of perioperative pelvic floor muscle training in improving the recovery of continence after radical prostatectomy: a randomized controlled trial. BJU Int. 2012 Oct;110(7):1004-10. doi: 10.1111/j.1464-410X.2012.10948.x. Epub 2012 Feb 14.
Results Reference
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PubMed Identifier
24859671
Citation
Jarvis TR, Sandhu JS. Management of urinary incontinence after radical prostatectomy. Curr Urol Rep. 2014 Jul;15(7):421. doi: 10.1007/s11934-014-0421-6.
Results Reference
background
PubMed Identifier
31808408
Citation
de Lira GHS, Fornari A, Cardoso LF, Aranchipe M, Kretiska C, Rhoden EL. Effects of perioperative pelvic floor muscle training on early recovery of urinary continence and erectile function in men undergoing radical prostatectomy: a randomized clinical trial. Int Braz J Urol. 2019 Nov-Dec;45(6):1196-1203. doi: 10.1590/S1677-5538.IBJU.2019.0238.
Results Reference
background
PubMed Identifier
31061057
Citation
Hodges P, Stafford R, Coughlin GD, Kasza J, Ashton-Miller J, Cameron AP, Connelly L, Hall LM. Efficacy of a personalised pelvic floor muscle training programme on urinary incontinence after radical prostatectomy (MaTchUP): protocol for a randomised controlled trial. BMJ Open. 2019 May 5;9(5):e028288. doi: 10.1136/bmjopen-2018-028288.
Results Reference
background
PubMed Identifier
30916232
Citation
Bernardes MFVG, Chagas SC, Izidoro LCR, Veloso DFM, Chianca TCM, Mata LRFPD. Impact of urinary incontinence on the quality of life of individuals undergoing radical prostatectomy. Rev Lat Am Enfermagem. 2019 Mar 10;27:e3131. doi: 10.1590/1518-8345.2757.3131. Erratum In: Rev Lat Am Enfermagem. 2019 Dec 05;27:e3244.
Results Reference
background
PubMed Identifier
26610857
Citation
Chang JI, Lam V, Patel MI. Preoperative Pelvic Floor Muscle Exercise and Postprostatectomy Incontinence: A Systematic Review and Meta-analysis. Eur Urol. 2016 Mar;69(3):460-7. doi: 10.1016/j.eururo.2015.11.004. Epub 2015 Nov 21.
Results Reference
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Bladder Training in Radical Prostatectomy

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