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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05700487
Other study ID # PROSTATK
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2019
Est. completion date April 29, 2021

Study information

Verified date January 2023
Source TC Erciyes University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date April 29, 2021
Est. primary completion date October 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 40 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
PELVIC FLOOR EXERCISES
Regular Pelvic floor exercises was performed three times a day for six months in the postoperative period

Locations

Country Name City State
Turkey ERciyes University Kayseri

Sponsors (1)

Lead Sponsor Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other The Marmara Post-Prostatectomy Incontinence Symptom Score Form 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.
Other The Marmara Post-Prostatectomy Incontinence Symptom Score Form 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.
Other The Marmara Post-Prostatectomy Incontinence Symptom Score Form 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.
Other The Marmara Post-Prostatectomy Incontinence Symptom Score Form 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.
Primary 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. The first measurement was made when the patients were included in the study.
Primary 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. It was performed at the 1st month follow-ups of the patients.
Primary 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. It was performed at the 3st month follow-ups of the patients.
Primary 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. It was performed at the 6st month follow-ups of the patients.
Secondary 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 first measurement was made when the patients were included in the study.
Secondary 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. It was performed at the 1st month follow-ups of the patients.
Secondary 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. It was performed at the 3st month follow-ups of the patients.
Secondary 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. It was performed at the 6st month follow-ups of the patients.
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