Kegel Exercise-focused Interventions in Elderly Women

October 24, 2020 updated by: Hilal Gamze Hakbilen, Akdeniz University

The Effect of Kegel Exercise-focused Interventions on Urinary Incontinence in Elderly Women

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Muratpaşa
      • Antalya, Muratpaşa, Turkey, 07310
        • Home Health Unit of Antalya Metropolitan Municipality

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6. week
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.
12. week
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.
6. week
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.
12. week
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. week
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.
12. week
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.
6. week
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.
12. week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
6. week
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.
12. week
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.
6. week
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.
12. week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Akdeniz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 21, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 17, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 28, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Akdeniz Uni

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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