NCT04213339

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 30, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

January 3, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

December 27, 2019

Last Update Submit

July 25, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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. 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?

    6 to 8 weeks

Study Arms (2)

Kegal Exercises

EXPERIMENTAL
Behavioral: Kegel Exercises

Control

NO INTERVENTION

Interventions

Kegel ExercisesBEHAVIORAL

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: 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

Kegal Exercises

Eligibility Criteria

Age50 Years - 80 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale old age geriatric population
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient 50 years of age and above.
  • Geriatric population
  • Male participant

You may not qualify if:

  • Patient below 50 years of age.
  • Patient with neurological problem.
  • Uncooperative attitude
  • Male patients with prostate problem \& Female participants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ali Sikandar Bhutto

Rawalpindi, Pakistan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single blinded
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 27, 2019

First Posted

December 30, 2019

Study Start

January 3, 2020

Primary Completion

May 28, 2020

Study Completion

June 30, 2020

Last Updated

July 28, 2020

Record last verified: 2020-07

Locations