Urinary Incontinence in Geriatric PopulationNCT04213339
Effectiveness of Kegal Exercises on Urinary Incontinence Impact in Geriatric Incontinence
A study testing Kegel Exercises in people with Urinary Incontinence in Geriatric Population, run by Zohra Institute of Health Sciences at 1 site in Pakistan.
Trial summary
This research study was used to determine effectiveness of kegal exercise on urinary incontinence impact in geriatric incontinence. There were two groups, One group was experimental which was subjected to Kegel exercises while other was control group without any treatment. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Urinary Incontinence in Geriatric Population
- What is being tested?
- Kegel Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Jan 2020to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient 50 years of age and above.
- Geriatric population
- Male participant
Who cannot join
- Patient below 50 years of age.
- Patient with neurological problem.
- Uncooperative attitude
- Male patients with prostate problem \& Female participants
Trial locations and contacts
1 site in 1 country.
About this study
This research study was used to determine effectiveness of kegal exercise on urinary incontinence impact in geriatric incontinence. There were two groups, One group was experimental which was subjected to Kegel exercises while other was control group without any treatment.
- Being tested
- Kegel Exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kegel ExercisesBehavioural
Kegel exercise group will get exercise within duration of 3 to 6 weeks based on age factor. Kegel exercise can be performed at any time and at any place without any restrictions.
following steps will be followed by kegel exercises group members:
- Tighten and hold pelvic floor muscles for five seconds (count 1 one thousand, 2 one thousand, 3 one thousand, 4 one thousand, 5 one thousand).
- Relax pelvic muscles and perform 10 to 20 Kegel exercises three to four times each day.
- Squeeze the muscles in anus like holding a bowel movement focus penile area
- Relax the pelvic floor muscles after each attempt.
- Repeat this exercise 10 to 20 times.
- While performing Kegel exercises:
Do not hold the breath. Do not push down. Squeeze the muscles together tightly and imagine, trying to lift this muscle up. Do not tighten the muscles in the stomach, buttocks, or thighs.
While the control group did not participate in any kegel exercises
| Study group | Role | What they receive |
|---|---|---|
| Kegal Exercises | Experimental | Not described Receives: Behavioral: Kegel Exercises |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incontinence Impact
Incontinence impact questionnaire description:
For each question, circle the response that best describes how much your activities, relationships, and feelings are being affected by urine leakage.
Scoring: Items 1 and 2 = physical activity Items 3 and 4 = travel Item 5 = social/relationships Items 6 and 7 = emotional health
Scoring. Item responses are assigned values of 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly." The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100.
- Ability to do household chores
- Physical recreation such as walking, swimming, or other exercise?
- Entertainment activities
- Ability to travel by car or bus more than 30 minutes from home.
- Participation in social activities outside your home
- Emotional health
- Feeling frustrated?
Measured: 6 to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start3 Jan 2020
- Primary completion28 May 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence in Geriatric PopulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zohra Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suhail Karim, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213339
- Sponsor's protocol ID
- ZIHS-Rwp/IRC/003
- Status last verified
- Jul 2020
- First submitted
- 27 Dec 2019
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Kegal Exercises on Urinary Incontinence Impact in Geriatric Incontinence
- ClinicalTrials.gov ID
- NCT04213339
- Acronym / sponsor ID
- ZIHS-Rwp/IRC/003
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Zohra Institute of Health SciencesUniversity, hospital or other
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 28 May 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 30 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study was used to determine effectiveness of kegal exercise on urinary incontinence impact in geriatric incontinence. There were two groups, One group was experimental which was subjected to Kegel exercises while other was control group without any treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kegal Exercises | Experimental | Behavioral: Kegel Exercises |
| Control | No intervention | – |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient 50 years of age and above.
- Geriatric population
- Male participant
Key exclusion criteria (4 listed)
- Patient below 50 years of age.
- Patient with neurological problem.
- Uncooperative attitude
- Male patients with prostate problem \& Female participants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kegel ExercisesKegel exercise group will get exercise within duration of 3 to 6 weeks based on age factor. Kegel exercise can be performed at any time and at any place without any restrictions. following steps will be followed by kegel exercises group members: 1. Tighten and hold pelvic floor muscles for five seconds (count 1 one thousand, 2 one thousand, 3 one thousand, 4 one thousand, 5 one thousand). 2. Relax pelvic muscles and perform 10 to 20 Kegel exercises three to four times each day. 3. Squeeze the muscles in anus like holding a bowel movement focus penile area 4. Relax the pelvic floor muscles after each attempt. 5. Repeat this exercise 10 to 20 times. 6. While performing Kegel exercises: Do not hold the breath. Do not push down. Squeeze the muscles together tightly and imagine, trying to lift this muscle up. Do not tighten the muscles in the stomach, buttocks, or thighs. While the control group did not participate in any kegel exercises | Behavioural | Kegal Exercises |
Primary outcome
Incontinence Impact
Time frame: 6 to 8 weeks
Incontinence impact questionnaire description: For each question, circle the response that best describes how much your activities, relationships, and feelings are being affected by urine leakage. Scoring: Items 1 and 2 = physical activity Items 3 and 4 = travel Item 5 = social/relationships Items 6 and 7 = emotional health Scoring. Item responses are assigned values of 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly." The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100. 1. Ability to do household chores 2. Physical recreation such as walking, swimming, or other exercise? 3. Entertainment activities 4. Ability to travel by car or bus more than 30 minutes from home. 5. Participation in social activities outside your home 6. Emotional health 7. Feeling frustrated?
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
Related trials for Urinary Incontinence in Geriatric Population
RecruitingObservational study
URINARY INCONTINENCE AND GERIATRIC SYNDROMES
Urinary Incontinence (UI), Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kegel Exercises in people with Urinary Incontinence in Geriatric Population, run by Zohra Institute of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incontinence Impact (time frame: 6 to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.