EFFECT ON QUALITY OF LIFE AFTER PROSTATECTOMY

URINARY INCONTINENCE Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05700487
• Other study ID #: PROSTATK
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Enuresis
• PROSTATECTOMY
• URINARY INCONTINENCE

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.