EFFECT ON QUALITY OF LIFE AFTER PROSTATECTOMY

NCT05700487 | Completed

• 1 other identifier: PROSTATK
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

PROSTATECTOMY; URINARY INCONTINENCE

Keywords

Radical Prostatectomy; Pelvic Floor Exercises; Urinary Incontinence; Quality of life

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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 Outcomes (4)

• The Overactive Bladder (OAB-V8 )

  The first measurement was made when the patients were included in the study.

• The Overactive Bladder (OAB-V8 )

  It was performed at the 1st month follow-ups of the patients.

• The Overactive Bladder (OAB-V8 )

  It was performed at the 3st month follow-ups of the patients.

• The Overactive Bladder (OAB-V8 )

  It was performed at the 6st month follow-ups of the patients.

Other Outcomes (4)

• The Marmara Post-Prostatectomy Incontinence Symptom Score Form

  The first measurement was made when the patients were included in the study.

• The Marmara Post-Prostatectomy Incontinence Symptom Score Form

  It was performed at the 1st month follow-ups of the patients.

• The Marmara Post-Prostatectomy Incontinence Symptom Score Form

  It was performed at the 3st month follow-ups of the patients.

Study Arms (2)

Control Group

NO INTERVENTION

Patients in this group continued their routine medicaltreatmentprogram without any treatment

Intervention Group

EXPERIMENTAL

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

Interventions

PELVIC FLOOR EXERCISES OTHER

Regular Pelvic floor exercises was performed three times a day for six months in the postoperative period

Also known as: Intervention Group

Intervention Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Gender Eligibility Details: Male patients were included because it was after prostatectomy.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- With bladder insufficiency (dysfunction),
• Individuals with a different type of incontinence problem such as stress incontinence, neurogenic bladder were not included in the study.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

ERciyes University

Kayseri, 38039, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 21834853 BACKGROUND

• 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.

  PMID: 25829950 BACKGROUND

• 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.

  PMID: 28168601 BACKGROUND

• 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.

  PMID: 25394949 BACKGROUND

• 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.

  PMID: 25287258 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The person applying the data sheets is an unbiased surveyor who does not know about the groups.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assosc.Prof.

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: January 26, 2023
• Study Start: August 1, 2019
• Primary Completion: October 30, 2020
• Study Completion: April 29, 2021
• Last Updated: January 27, 2023

Record last verified: 2023-01

Locations

TU (1)