EFFECT ON QUALITY OF LIFE AFTER PROSTATECTOMY

Sponsor
TC Erciyes University (Other)
Overall Status
Completed
CT.gov ID
NCT05700487
Collaborator
(none)
33
1
2
20.9
1.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: PELVIC FLOOR EXERCISES
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Masking Description:
The person applying the data sheets is an unbiased surveyor who does not know about the groups.
Primary Purpose:
Health Services Research
Official Title:
THE EFFECT OF PELVIC FLOOR EXERCISES ON URINARY INCONTINENCE AND QUALITY OF LIFE AFTER PROSTATECTOMY
Actual Study Start Date :
Aug 1, 2019
Actual Primary Completion Date :
Oct 30, 2020
Actual Study Completion Date :
Apr 29, 2021

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Quality of life Scale(SF-36) [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.

    2. Quality of life Scale(SF-36) [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.

    3. Quality of life Scale(SF-36) [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.

    4. Quality of life Scale(SF-36) [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.

    Secondary Outcome Measures

    1. The Overactive Bladder (OAB-V8 ) [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.

    2. The Overactive Bladder (OAB-V8 ) [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.

    3. The Overactive Bladder (OAB-V8 ) [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.

    4. The Overactive Bladder (OAB-V8 ) [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.

    Other Outcome Measures

    1. The Marmara Post-Prostatectomy Incontinence Symptom Score Form [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.

    2. The Marmara Post-Prostatectomy Incontinence Symptom Score Form [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.

    3. The Marmara Post-Prostatectomy Incontinence Symptom Score Form [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.

    4. The Marmara Post-Prostatectomy Incontinence Symptom Score Form [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 75 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ERciyes University Kayseri Turkey 38039

    Sponsors and Collaborators

    • TC Erciyes University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Özlem Ceyhan, Assosc.Prof., TC Erciyes University
    ClinicalTrials.gov Identifier:
    NCT05700487
    Other Study ID Numbers:
    • PROSTATK
    First Posted:
    Jan 26, 2023
    Last Update Posted:
    Jan 27, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Özlem Ceyhan, Assosc.Prof., TC Erciyes University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 27, 2023