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Completed

NCT Number: NCT05700487

EFFECT ON 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.

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Key information

Conditions

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

Age range

40 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

ERciyes University

Kayseri, 38039, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pelvic floor exercises

Other

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

Other names: Intervention Group

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jan 26, 2023
Registry last updated
Jan 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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