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EFFECT ON QUALITY OF LIFE AFTER PROSTATECTOMY

Primary Purpose

PROSTATECTOMY, URINARY INCONTINENCE

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
PELVIC FLOOR EXERCISES
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for PROSTATECTOMY focused on measuring Radical Prostatectomy, Pelvic Floor Exercises, Urinary Incontinence, Quality of life

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Being literate, Having the mental competence to understand the questions, Radical prostatectomy was performed due to the diagnosis of localized prostate cancer, Continuing post-operative follow-up, No incontinence problem before surgery, Anatomically free of genito-urinary system pathology, Those who volunteered to participate in the study were recruited. Exclusion Criteria: - With bladder insufficiency (dysfunction), • Individuals with a different type of incontinence problem such as stress incontinence, neurogenic bladder were not included in the study.

Sites / Locations

  • ERciyes University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Intervention Group

Arm Description

Patients in this group continued their routine medicaltreatmentprogram without any treatment

Pelvic floor exercises (PTE) training in the preoperative period, regular PTE was performed three times a day for 6 months in the postoperative period, and the continuity of the exercises was checked by telephone

Outcomes

Primary Outcome Measures

Quality of life Scale(SF-36)
It measures the quality of life of individuals in 7 dimensions. These dimensions are physical function, social function, role limitations due to physical functions, role limitations due to emotional problems, mental health energy/vitality, pain and general perception of health. Instead of giving only a single total score, the scale is for each subscale. gives a total score separately. Subscales evaluate health from 0 to 100. "0 points" denotes the worst health condition, and "100 points" denotes the best health condition.
Quality of life Scale(SF-36)
It measures the quality of life of individuals in 7 dimensions. These dimensions are physical function, social function, role limitations due to physical functions, role limitations due to emotional problems, mental health energy/vitality, pain and general perception of health. Instead of giving only a single total score, the scale is for each subscale. gives a total score separately. Subscales evaluate health from 0 to 100. "0 points" denotes the worst health condition, and "100 points" denotes the best health condition.
Quality of life Scale(SF-36)
It measures the quality of life of individuals in 7 dimensions. These dimensions are physical function, social function, role limitations due to physical functions, role limitations due to emotional problems, mental health energy/vitality, pain and general perception of health. Instead of giving only a single total score, the scale is for each subscale. gives a total score separately. Subscales evaluate health from 0 to 100. "0 points" denotes the worst health condition, and "100 points" denotes the best health condition.
Quality of life Scale(SF-36)
It measures the quality of life of individuals in 7 dimensions. These dimensions are physical function, social function, role limitations due to physical functions, role limitations due to emotional problems, mental health energy/vitality, pain and general perception of health. Instead of giving only a single total score, the scale is for each subscale. gives a total score separately. Subscales evaluate health from 0 to 100. "0 points" denotes the worst health condition, and "100 points" denotes the best health condition.

Secondary Outcome Measures

The Overactive Bladder (OAB-V8 )
Used to determine clinical incontinence. The OAB- V8 inquiry form determined the severity of the patients' complaints, none (0); very few (1); a little (2); quite a few (3); many (4); and it consists of 8 questions that can be graded as too many (5). The total score ranges from 0 to 40.
The Overactive Bladder (OAB-V8 )
Used to determine clinical incontinence. The OAB- V8 inquiry form determined the severity of the patients' complaints, none (0); very few (1); a little (2); quite a few (3); many (4); and it consists of 8 questions that can be graded as too many (5). The total score ranges from 0 to 40.
The Overactive Bladder (OAB-V8 )
Used to determine clinical incontinence. The OAB- V8 inquiry form determined the severity of the patients' complaints, none (0); very few (1); a little (2); quite a few (3); many (4); and it consists of 8 questions that can be graded as too many (5). The total score ranges from 0 to 40.
The Overactive Bladder (OAB-V8 )
Used to determine clinical incontinence. The OAB- V8 inquiry form determined the severity of the patients' complaints, none (0); very few (1); a little (2); quite a few (3); many (4); and it consists of 8 questions that can be graded as too many (5). The total score ranges from 0 to 40.

Full Information

First Posted
January 17, 2023
Last Updated
January 26, 2023
Sponsor
TC Erciyes University
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1. Study Identification

Unique Protocol Identification Number
NCT05700487
Brief Title
EFFECT ON QUALITY OF LIFE AFTER PROSTATECTOMY
Official Title
THE EFFECT OF PELVIC FLOOR EXERCISES ON URINARY INCONTINENCE AND QUALITY OF LIFE AFTER PROSTATECTOMY
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
April 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University

4. Oversight

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

5. Study Description

Brief Summary
Aim: This study was conducted to determine the effect of pelvic floor exercises (PTE) on urinary incontinence and quality of life (QOL) after radical prostatectomy (RP). Methods: This randomized controlled, single-blind, experimental study was completed with a total of 33 RP patients, 18 of whom were interventions, and 15 were controls. The intervention group was given pelvic floor exercises (PTE) training in the preoperative period, regular PTE was performed three times a day for six months in the postoperative period, and the continuity of the exercises was checked by telephone. On the other hand, no intervention was applied to the control group other than routine treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PROSTATECTOMY, URINARY INCONTINENCE
Keywords
Radical Prostatectomy, Pelvic Floor Exercises, Urinary Incontinence, Quality of life

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
The person applying the data sheets is an unbiased surveyor who does not know about the groups.
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients in this group continued their routine medicaltreatmentprogram without any treatment
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Pelvic floor exercises (PTE) training in the preoperative period, regular PTE was performed three times a day for 6 months in the postoperative period, and the continuity of the exercises was checked by telephone
Intervention Type
Other
Intervention Name(s)
PELVIC FLOOR EXERCISES
Other Intervention Name(s)
Intervention Group
Intervention Description
Regular Pelvic floor exercises was performed three times a day for six months in the postoperative period
Primary Outcome Measure Information:
Title
Quality of life Scale(SF-36)
Description
It measures the quality of life of individuals in 7 dimensions. These dimensions are physical function, social function, role limitations due to physical functions, role limitations due to emotional problems, mental health energy/vitality, pain and general perception of health. Instead of giving only a single total score, the scale is for each subscale. gives a total score separately. Subscales evaluate health from 0 to 100. "0 points" denotes the worst health condition, and "100 points" denotes the best health condition.
Time Frame
The first measurement was made when the patients were included in the study.
Title
Quality of life Scale(SF-36)
Description
It measures the quality of life of individuals in 7 dimensions. These dimensions are physical function, social function, role limitations due to physical functions, role limitations due to emotional problems, mental health energy/vitality, pain and general perception of health. Instead of giving only a single total score, the scale is for each subscale. gives a total score separately. Subscales evaluate health from 0 to 100. "0 points" denotes the worst health condition, and "100 points" denotes the best health condition.
Time Frame
It was performed at the 1st month follow-ups of the patients.
Title
Quality of life Scale(SF-36)
Description
It measures the quality of life of individuals in 7 dimensions. These dimensions are physical function, social function, role limitations due to physical functions, role limitations due to emotional problems, mental health energy/vitality, pain and general perception of health. Instead of giving only a single total score, the scale is for each subscale. gives a total score separately. Subscales evaluate health from 0 to 100. "0 points" denotes the worst health condition, and "100 points" denotes the best health condition.
Time Frame
It was performed at the 3st month follow-ups of the patients.
Title
Quality of life Scale(SF-36)
Description
It measures the quality of life of individuals in 7 dimensions. These dimensions are physical function, social function, role limitations due to physical functions, role limitations due to emotional problems, mental health energy/vitality, pain and general perception of health. Instead of giving only a single total score, the scale is for each subscale. gives a total score separately. Subscales evaluate health from 0 to 100. "0 points" denotes the worst health condition, and "100 points" denotes the best health condition.
Time Frame
It was performed at the 6st month follow-ups of the patients.
Secondary Outcome Measure Information:
Title
The Overactive Bladder (OAB-V8 )
Description
Used to determine clinical incontinence. The OAB- V8 inquiry form determined the severity of the patients' complaints, none (0); very few (1); a little (2); quite a few (3); many (4); and it consists of 8 questions that can be graded as too many (5). The total score ranges from 0 to 40.
Time Frame
The first measurement was made when the patients were included in the study.
Title
The Overactive Bladder (OAB-V8 )
Description
Used to determine clinical incontinence. The OAB- V8 inquiry form determined the severity of the patients' complaints, none (0); very few (1); a little (2); quite a few (3); many (4); and it consists of 8 questions that can be graded as too many (5). The total score ranges from 0 to 40.
Time Frame
It was performed at the 1st month follow-ups of the patients.
Title
The Overactive Bladder (OAB-V8 )
Description
Used to determine clinical incontinence. The OAB- V8 inquiry form determined the severity of the patients' complaints, none (0); very few (1); a little (2); quite a few (3); many (4); and it consists of 8 questions that can be graded as too many (5). The total score ranges from 0 to 40.
Time Frame
It was performed at the 3st month follow-ups of the patients.
Title
The Overactive Bladder (OAB-V8 )
Description
Used to determine clinical incontinence. The OAB- V8 inquiry form determined the severity of the patients' complaints, none (0); very few (1); a little (2); quite a few (3); many (4); and it consists of 8 questions that can be graded as too many (5). The total score ranges from 0 to 40.
Time Frame
It was performed at the 6st month follow-ups of the patients.
Other Pre-specified Outcome Measures:
Title
The Marmara Post-Prostatectomy Incontinence Symptom Score Form
Description
It determines how incontinence affects an individual's life. The survey consists of 8 questions and 3 parts. Point values between 0 and 28 can be obtained from the questionnaire. A high total score indicates an increase in the negative impact of incontinence on the patient.
Time Frame
The first measurement was made when the patients were included in the study.
Title
The Marmara Post-Prostatectomy Incontinence Symptom Score Form
Description
It determines how incontinence affects an individual's life. The survey consists of 8 questions and 3 parts. Point values between 0 and 28 can be obtained from the questionnaire. A high total score indicates an increase in the negative impact of incontinence on the patient.
Time Frame
It was performed at the 1st month follow-ups of the patients.
Title
The Marmara Post-Prostatectomy Incontinence Symptom Score Form
Description
It determines how incontinence affects an individual's life. The survey consists of 8 questions and 3 parts. Point values between 0 and 28 can be obtained from the questionnaire. A high total score indicates an increase in the negative impact of incontinence on the patient.
Time Frame
It was performed at the 3st month follow-ups of the patients.
Title
The Marmara Post-Prostatectomy Incontinence Symptom Score Form
Description
It determines how incontinence affects an individual's life. The survey consists of 8 questions and 3 parts. Point values between 0 and 28 can be obtained from the questionnaire. A high total score indicates an increase in the negative impact of incontinence on the patient.
Time Frame
It was performed at the 6st month follow-ups of the patients.

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male patients were included because it was after prostatectomy.
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being literate, Having the mental competence to understand the questions, Radical prostatectomy was performed due to the diagnosis of localized prostate cancer, Continuing post-operative follow-up, No incontinence problem before surgery, Anatomically free of genito-urinary system pathology, Those who volunteered to participate in the study were recruited. Exclusion Criteria: - With bladder insufficiency (dysfunction), • Individuals with a different type of incontinence problem such as stress incontinence, neurogenic bladder were not included in the study.
Facility Information:
Facility Name
ERciyes University
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
21834853
Citation
Gacci M, Carini M, Simonato A, Imbimbo C, Gontero P, Briganti A, De Cobelli O, Fulcoli V, Martorana G, Nicita G, Mirone V, Carmignani G. Factors predicting continence recovery 1 month after radical prostatectomy: results of a multicenter survey. Int J Urol. 2011 Oct;18(10):700-8. doi: 10.1111/j.1442-2042.2011.02826.x. Epub 2011 Aug 11.
Results Reference
background
PubMed Identifier
25829950
Citation
Almallah YZ, Grimsley SJ. A report of a regional service for post-prostatectomy urinary incontinence: a model for best practice? Ther Adv Urol. 2015 Apr;7(2):69-75. doi: 10.1177/1756287214561625.
Results Reference
background
PubMed Identifier
28168601
Citation
Venderbos LDF, Aluwini S, Roobol MJ, Bokhorst LP, Oomens EHGM, Bangma CH, Korfage IJ. Long-term follow-up after active surveillance or curative treatment: quality-of-life outcomes of men with low-risk prostate cancer. Qual Life Res. 2017 Jun;26(6):1635-1645. doi: 10.1007/s11136-017-1507-7. Epub 2017 Feb 6.
Results Reference
background
PubMed Identifier
25394949
Citation
Santa Mina D, Matthew AG, Hilton WJ, Au D, Awasthi R, Alibhai SM, Clarke H, Ritvo P, Trachtenberg J, Fleshner NE, Finelli A, Wijeysundera D, Aprikian A, Tanguay S, Carli F. Prehabilitation for men undergoing radical prostatectomy: a multi-centre, pilot randomized controlled trial. BMC Surg. 2014 Nov 13;14:89. doi: 10.1186/1471-2482-14-89.
Results Reference
background
PubMed Identifier
25287258
Citation
Lee EW, Kobashi KC. Mixed incontinence: what takes precedence in its management? Curr Urol Rep. 2014 Dec;15(12):461. doi: 10.1007/s11934-014-0461-y.
Results Reference
background

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EFFECT ON QUALITY OF LIFE AFTER PROSTATECTOMY

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