Kegel Exercise-focused Interventions in Elderly Women

NCT04608929 | Completed DMC

• 1 other identifier: Akdeniz Uni
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence; Kegel Exercises; Nursing

Outcome Measures

Primary Outcomes (8)

• Change in frequency of urinary incontinence after onset

  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. week

• Change in frequency of urinary incontinence after onset

  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.

  12. week

• Change in amount of urinary incontinence after onset

  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. week

• Change in amount of urinary incontinence after onset

  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.

  12. week

• Change in effects of urinary incontinence on daily life after onset

  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. week

• Change in effects of urinary incontinence on daily life after onset

  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.

  12. week

• Change in assessment of the perceived impact after onset

  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.

  6. week

• Change in assessment of the perceived impact after onset

  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.

  12. week

Secondary Outcomes (4)

• Evaluation of the participants in terms of performing Kegel Exercises

  6. week

• Evaluation of the participants in terms of performing Kegel Exercises

  12. week

• Assesment of which cases do you leak urine?

  6. week

• Assesment of which cases do you leak urine?

  12. week

Study Arms (2)

Intervention

EXPERIMENTAL

The arm where the Kegel exercise focused intervention is applied

Behavioral: Kegel exercise-focused interventions

Control

EXPERIMENTAL

The arm where home follow-up and scale evaluations are made

Other: Home visit and scale evaluations

Interventions

Kegel exercise-focused interventions BEHAVIORAL

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.

Intervention

Home visit and scale evaluations OTHER

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.

Control

Eligibility Criteria

• Age: 65 Years+
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Home Health Unit of Antalya Metropolitan Municipality

Antalya, Muratpaşa, 07310, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence

Interventions

House Calls

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

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 29, 2020
• Study Start: December 21, 2017
• Primary Completion: March 17, 2019
• Study Completion: June 28, 2019
• Last Updated: October 29, 2020

Record last verified: 2020-10

Locations

TU (1)