Kegel Exercise-focused Interventions in Elderly Women

• ClinicalTrials.gov Identifier: NCT04608929
• Recruitment Status: Completed
• First Posted: October 29, 2020
• Last Update Posted: October 29, 2020
• Sponsor: Akdeniz University
• Information provided by (Responsible Party): Hilal Gamze Hakbilen, Akdeniz University

Study Description

Brief Summary:

Purpose: This study was conducted to investigate the effects of Kegel exercises-focused intervention undergone by elderly women diagnosed with urinary incontinence on their incontinence, quality of life and perceived impact level.

Design: The study has a single-blind randomized controlled experimental research design.

Methods: The study was carried out between December 2017 and March 2019 with 60 elderly women registered at the Home Health Unit of a Metropolitan Municipality in Turkey. The women were assigned to the intervention (n=30) and control (n=30) groups. The participants in the intervention group were paid home visits to provide them with individual training and counseling on Kegel exercises. Whether the participants did the exercises was followed up by weekly phone calls. The frequency of urinary incontinence, the amount of urine leaking and the quality of life of the participants and their complaints about incontinence were assessed with the International Consultation on Incontinence Questionnaire Short Form and questions on the assessment of the perceived impact at the onset of the study (0th week), and at home visits paid at the 6th and 12th weeks after the intervention.

Condition or disease	Intervention/treatment	Phase
Urinary Incontinence; Kegel Exercises; Nursing	Behavioral: Kegel exercise-focused interventions; Other: Home visit and scale evaluations	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Effect of Kegel Exercise-focused Interventions on Urinary Incontinence in Elderly Women
• Actual Study Start Date: December 21, 2017
• Actual Primary Completion Date: March 17, 2019
• Actual Study Completion Date: June 28, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention; The arm where the Kegel exercise focused intervention is applied	Behavioral: Kegel exercise-focused interventions; After the patients in the intervention group were interviewed on the telephone, the second home visit. During this visit, the patients were trained on Kegel exercises and they were administered the ICIQ-SF. Six weeks after the second visit, the third home visit was paid to determine whether the patients did the Kegel exercises and whether they did them accurately, to assess the perceived impact and to re-administer the ICIQ-SF. After the 2nd and 3rd visit, the patients were called once a week for 6 weeks to monitor if they kept up with doing the Kegel exercises as they were taught. Six weeks later, the 4th home visit were paid to the patients. During this visit, whether the patients did the Kegel exercises and whether they did them accurately was determined, the perceived impact was assessed and the ICIQ-SF was re-administered.
Experimental: Control; The arm where home follow-up and scale evaluations are made	Other: Home visit and scale evaluations; After the 1st visit, the patients included in the control group were called by phone and the 2nd home visit was planned. During the second home visit, the ICIQ-SF was administered to them. At the 3rd home visit paid 6 weeks after the 2nd visit, the ICIQ-SF was re-administered to the patients and the perceived impact assessment was performed. During the 4th home visit paid 6 weeks after the 3rd home visit, the ICIQ-SF was re-administered to the patients, assessment of the perceived impact was performed, and finally they were given training on Kegel exercises.

Outcome Measures

Primary Outcome Measures :

1. Change in frequency of urinary incontinence after onset [ Time Frame: 6. week ]
   The International Consultation on Incontinence Questionnaire Short Form has the following four sub-dimensions: frequency of urinary incontinence, the amount of leakage, the impact of urinary incontinence on daily life, and causes of urinary incontinence. The first three sub-dimensions are included in scoring. The responses given to the fourth dimension, which is not included in the scoring process enable the health professional to determine the type of urinary incontinence based on the person's complaints. The minimum and maximum possible scores to be obtained from the scale are 0 and 21 respectively. While low scores indicate that urinary incontinence has little impact on the quality of life, high scores indicate that urinary incontinence has a great impact on the quality of life.
2. Change in frequency of urinary incontinence after onset [ Time Frame: 12. week ]
   The International Consultation on Incontinence Questionnaire Short Form has the following four sub-dimensions: frequency of urinary incontinence, the amount of leakage, the impact of urinary incontinence on daily life, and causes of urinary incontinence. The first three sub-dimensions are included in scoring. The responses given to the fourth dimension, which is not included in the scoring process enable the health professional to determine the type of urinary incontinence based on the person's complaints. The minimum and maximum possible scores to be obtained from the scale are 0 and 21 respectively. While low scores indicate that urinary incontinence has little impact on the quality of life, high scores indicate that urinary incontinence has a great impact on the quality of life.
3. Change in amount of urinary incontinence after onset [ Time Frame: 6. week ]
   The International Consultation on Incontinence Questionnaire Short Form has the following four sub-dimensions: frequency of urinary incontinence, the amount of leakage, the impact of urinary incontinence on daily life, and causes of urinary incontinence. The first three sub-dimensions are included in scoring. The responses given to the fourth dimension, which is not included in the scoring process enable the health professional to determine the type of urinary incontinence based on the person's complaints. The minimum and maximum possible scores to be obtained from the scale are 0 and 21 respectively. While low scores indicate that urinary incontinence has little impact on the quality of life, high scores indicate that urinary incontinence has a great impact on the quality of life.
4. Change in amount of urinary incontinence after onset [ Time Frame: 12. week ]
   The International Consultation on Incontinence Questionnaire Short Form has the following four sub-dimensions: frequency of urinary incontinence, the amount of leakage, the impact of urinary incontinence on daily life, and causes of urinary incontinence. The first three sub-dimensions are included in scoring. The responses given to the fourth dimension, which is not included in the scoring process enable the health professional to determine the type of urinary incontinence based on the person's complaints. The minimum and maximum possible scores to be obtained from the scale are 0 and 21 respectively. While low scores indicate that urinary incontinence has little impact on the quality of life, high scores indicate that urinary incontinence has a great impact on the quality of life.
5. Change in effects of urinary incontinence on daily life after onset [ Time Frame: 6. week ]
   The International Consultation on Incontinence Questionnaire Short Form has the following four sub-dimensions: frequency of urinary incontinence, the amount of leakage, the impact of urinary incontinence on daily life, and causes of urinary incontinence. The first three sub-dimensions are included in scoring. The responses given to the fourth dimension, which is not included in the scoring process enable the health professional to determine the type of urinary incontinence based on the person's complaints. The minimum and maximum possible scores to be obtained from the scale are 0 and 21 respectively. While low scores indicate that urinary incontinence has little impact on the quality of life, high scores indicate that urinary incontinence has a great impact on the quality of life.
6. Change in effects of urinary incontinence on daily life after onset [ Time Frame: 12. week ]
   The International Consultation on Incontinence Questionnaire Short Form has the following four sub-dimensions: frequency of urinary incontinence, the amount of leakage, the impact of urinary incontinence on daily life, and causes of urinary incontinence. The first three sub-dimensions are included in scoring. The responses given to the fourth dimension, which is not included in the scoring process enable the health professional to determine the type of urinary incontinence based on the person's complaints. The minimum and maximum possible scores to be obtained from the scale are 0 and 21 respectively. While low scores indicate that urinary incontinence has little impact on the quality of life, high scores indicate that urinary incontinence has a great impact on the quality of life.
7. Change in assessment of the perceived impact after onset [ Time Frame: 6. week ]
   Patient Information Form developed by the researchers based on the pertinent literature consists of 5 parts and 28 questions. The first part questions the patient's age, height, weight etc. The second part is on the patient's obstetric characteristics. The third part questions the patient's health history. The fourth part questions the patient's incontinence status. The fifth part is on the assessment of the perceived impact.
8. Change in assessment of the perceived impact after onset [ Time Frame: 12. week ]
   Patient Information Form developed by the researchers based on the pertinent literature consists of 5 parts and 28 questions. The first part questions the patient's age, height, weight etc. The second part is on the patient's obstetric characteristics. The third part questions the patient's health history. The fourth part questions the patient's incontinence status. The fifth part is on the assessment of the perceived impact.

Secondary Outcome Measures :

1. Evaluation of the participants in terms of performing Kegel Exercises [ Time Frame: 6. week ]
   The Weekly Exercise Follow-up Form was developed by the researchers to assess the frequency of exercises in patients who were given Kegel exercise training. The Weekly Exercise Follow-up Form has a timetable consisting of 7 days of the week and 3 parts of the day (morning, noon and evening). The patients mark the timetable by placing an "X" on the blank corresponding to the time when they perform the exercise.
2. Evaluation of the participants in terms of performing Kegel Exercises [ Time Frame: 12. week ]
   The Weekly Exercise Follow-up Form was developed by the researchers to assess the frequency of exercises in patients who were given Kegel exercise training. The Weekly Exercise Follow-up Form has a timetable consisting of 7 days of the week and 3 parts of the day (morning, noon and evening). The patients mark the timetable by placing an "X" on the blank corresponding to the time when they perform the exercise.
3. Assesment of which cases do you leak urine? [ Time Frame: 6. week ]
   The International Consultation on Incontinence Questionnaire Short Form has the following four sub-dimensions: frequency of urinary incontinence, the amount of leakage, the impact of urinary incontinence on daily life, and causes of urinary incontinence. The first three sub-dimensions are included in scoring. The responses given to the fourth dimension, which is not included in the scoring process enable the health professional to determine the type of urinary incontinence based on the person's complaints. The minimum and maximum possible scores to be obtained from the scale are 0 and 21 respectively. While low scores indicate that urinary incontinence has little impact on the quality of life, high scores indicate that urinary incontinence has a great impact on the quality of life.
4. Assesment of which cases do you leak urine? [ Time Frame: 12. week ]
   The International Consultation on Incontinence Questionnaire Short Form has the following four sub-dimensions: frequency of urinary incontinence, the amount of leakage, the impact of urinary incontinence on daily life, and causes of urinary incontinence. The first three sub-dimensions are included in scoring. The responses given to the fourth dimension, which is not included in the scoring process enable the health professional to determine the type of urinary incontinence based on the person's complaints. The minimum and maximum possible scores to be obtained from the scale are 0 and 21 respectively. While low scores indicate that urinary incontinence has little impact on the quality of life, high scores indicate that urinary incontinence has a great impact on the quality of life.

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Over the age of 65,
• Being women,
• Diagnosed with UI,
• Being literate,
• Being able to communicate in Turkish,
• Standardized Mini Mental Test result was > 24,
• Agree to participate in research.

Exclusion Criteria:

• Who had received training on incontinence and Kegel exercises in the last 1 year,
• Had symptoms of urinary tract infection were identified,
• Being treated for UI,
• Having health problems affecting the muscle and nervous system,
• Being not able to perform daily life activities,
• Having pelvic organ prolapse,

Contacts and Locations

Locations

Turkey

Home Health Unit of Antalya Metropolitan Municipality

Antalya, Muratpaşa, Turkey, 07310

Sponsors and Collaborators

Akdeniz University

More Information

• Responsible Party: Hilal Gamze Hakbilen, Research Assistant, Akdeniz University
• ClinicalTrials.gov Identifier: NCT04608929
• Other Study ID Numbers: Akdeniz Uni
• First Posted: October 29, 2020
• Last Update Posted: October 29, 2020
• Last Verified: October 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Urinary Incontinence; Enuresis; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Mental Disorders