EFFECT ON QUALITY OF LIFE AFTER PROSTATECTOMY

January 26, 2023 updated by: Özlem Ceyhan, TC Erciyes University

THE EFFECT OF PELVIC FLOOR EXERCISES ON URINARY INCONTINENCE AND QUALITY OF LIFE AFTER PROSTATECTOMY

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kayseri, Turkey, 38039
        • Erciyes University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Patients in this group continued their routine medicaltreatmentprogram without any treatment
Experimental: Intervention Group
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
Other: PELVIC FLOOR EXERCISES
Regular Pelvic floor exercises was performed three times a day for six months in the postoperative period
Other Names:
  • Intervention Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life Scale(SF-36)
Time Frame: The first measurement was made when the patients were included in the study.
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.
The first measurement was made when the patients were included in the study.
Quality of life Scale(SF-36)
Time Frame: It was performed at the 1st month follow-ups of the patients.
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.
It was performed at the 1st month follow-ups of the patients.
Quality of life Scale(SF-36)
Time Frame: It was performed at the 3st month follow-ups of the patients.
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.
It was performed at the 3st month follow-ups of the patients.
Quality of life Scale(SF-36)
Time Frame: It was performed at the 6st month follow-ups of the patients.
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.
It was performed at the 6st month follow-ups of the patients.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Overactive Bladder (OAB-V8 )
Time Frame: The first measurement was made when the patients were included in the study.
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 first measurement was made when the patients were included in the study.
The Overactive Bladder (OAB-V8 )
Time Frame: It was performed at the 1st month follow-ups of the patients.
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.
It was performed at the 1st month follow-ups of the patients.
The Overactive Bladder (OAB-V8 )
Time Frame: It was performed at the 3st month follow-ups of the patients.
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.
It was performed at the 3st month follow-ups of the patients.
The Overactive Bladder (OAB-V8 )
Time Frame: It was performed at the 6st month follow-ups of the patients.
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.
It was performed at the 6st month follow-ups of the patients.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Marmara Post-Prostatectomy Incontinence Symptom Score Form
Time Frame: The first measurement was made when the patients were included in the study.
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.
The first measurement was made when the patients were included in the study.
The Marmara Post-Prostatectomy Incontinence Symptom Score Form
Time Frame: It was performed at the 1st month follow-ups of the patients.
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.
It was performed at the 1st month follow-ups of the patients.
The Marmara Post-Prostatectomy Incontinence Symptom Score Form
Time Frame: It was performed at the 3st month follow-ups of the patients.
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.
It was performed at the 3st month follow-ups of the patients.
The Marmara Post-Prostatectomy Incontinence Symptom Score Form
Time Frame: It was performed at the 6st month follow-ups of the patients.
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.
It was performed at the 6st month follow-ups of the patients.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Actual)

October 30, 2020

Study Completion (Actual)

April 29, 2021

Study Registration Dates

First Submitted

January 17, 2023

First Submitted That Met QC Criteria

January 17, 2023

First Posted (Actual)

January 26, 2023

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROSTATK

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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