Back to resultsEffects of Hypopressive Exercises in Comparison With Routine Pelvic Floor Exercises in Women With Urinary Incontinence
Primary Purpose
Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Hypopressive exercises
Pelvic floor exercises
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring Urinary Incontinence, Pelvic floor exercises, Hypopressive exercises
Eligibility Criteria
Inclusion Criteria:
- Women aged between 20 to 65 years
- Gynecologist and urologist diagnosed patients
- Participants not engaged systematically in sports or physical activities(≤ sessions per week, ≤ weeks per week)
Exclusion Criteria:
- If participants had hypertension or any serious mental disease
- Pregnancy or up to 2 months postpartum
- Urge fecal incontinence or vaginal pain
- Underwent any physiotherapy for urinary incontinence before
- Any kidney disease
Sites / Locations
- Riphah International University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Hypopressive exercises and electrical muscle stimulation (EMS)
Pelvic floor muscle exercises and electrical muscle stimulation (EMS)
Arm Description
Women included in this group underwent 24 sessions during 8 weeks (3 days/ week). Treatment will be given for 50 minutes in each session. Electrical muscle stimulation (EMS) will be applied in prone lying before every session of hypopressive exercises (HE). A device will use for muscle stimulation at 7Hz for 15 minutes. The intensity of current will gradually increase from zero to a minimum that can be tolerated by the patient. Two electrodes will place medially to the ischial tuberosity and the remaining two will place on the sacral area. After a 2-minute interval, the patient will be asked to perform HE in an upright position. For this maneuver, the patient will be instructed to inhale, then breathe to expand the ribcage, and then exhale completely. Hold the breath out before relaxing core and ribcage. Four sets of 10 repetitions with a 3-minute interval between each set will be performed.
Women included in this group underwent 24 sessions during 8 weeks (3 days/ week). Treatment will be given for 50 minutes in each session. Electrical muscle stimulation (EMS) will be applied in prone lying before every session of pelvic floor muscle exercises. A device will use for muscle stimulation at 7Hz for 15 minutes. The intensity of current will gradually increase from zero to a minimum that can be tolerated by the patient. Two electrodes will place medially to the ischial tuberosity and the remaining two will place on the sacral area. After a 2-minute interval, the patient will be asked to perform pelvic floor muscle exercises in a sitting position. The patient is instructed to hold each contraction for 6 seconds, with three to four contractions added on the top. Four sets of 10 repetitions with a 2-minute interval between each set will be performed.
Outcomes
Primary Outcome Measures
International Consultation Incontinence Questionnaire Short Form (ICIQ-SF)
ICIQ-SF is a screening tool for incontinence. 4 main items (a total of 6) ask for a rating of symptoms in past four weeks. Item 1 and 2 are demographics so items 3,4,5 are summed for a total score. Using a score value, UI is classified as mild (1-5), moderate (6-12), severe (13-18), very severe (19-21) from a total score ranges from 0-21.
International Impact Questionnaire, Short Form (IIQ-7)
IIQ-7 is a reliable tool for measuring the impact on quality of life for UI patients. Calculate the mean of all items and then subtract the mean by 1, then multiply by 100/3 (0-100 range).
Medical, Epidemiologic and Social aspects of Aging Questionnaire (MESA Questionnaire)
It is a reliable and validated tool to evaluate the severity and predominance of stress and urge urinary incontinence. The MESA Questionnaire consists of 15 items total divided into stress (1-9) and urge (10-15) subscales. The total score of urgency (18) and stress (27) is divided into three degrees. For urgency, a score of 1-6 is categorized as mild, 7-12 moderate, and 13-18 as severe. For stress, a score of 1-9 is categorized as mild, 10-18 moderate, and 19-27 as severe. A higher MESA score indicates more frequent symptoms overall ranges from 0-45.
Secondary Outcome Measures
Full Information
NCT ID
NCT05239949
First Posted
February 4, 2022
Last Updated
May 31, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05239949
Brief Title
Effects of Hypopressive Exercises in Comparison With Routine Pelvic Floor Exercises in Women With Urinary Incontinence
Official Title
Effects of Hypopressive Exercises in Comparison With Routine Pelvic Floor Exercises in Women With Urinary Incontinence: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
February 20, 2022 (Actual)
Study Completion Date
February 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of our study is to compare the effects of hypopressive exercises with routine pelvic floor exercises in improving the frequency and severity of urinary incontinence in women and also to enhance their quality of life as it worsens after childbirth, pregnancy, and in older age.
Detailed Description
A randomized control trial study will be conducted in which patients with urinary incontinence will be assigned to group 1 that will receive hypopressive exercises with electrical muscle stimulation (EMS) and patients in group 2 will receive pelvic floor exercises with EMS.
The intervention will be applied (3 days/week) for 8 weeks. Four sets of 10 repetitions with a 3-minute interval between each set will be performed for group 1 in an upright position while four sets of 10 repetitions with a 2-minute interval between each set will be performed for group 2 in the sitting position.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Urinary Incontinence, Pelvic floor exercises, Hypopressive exercises
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
our study will be single-blinded, outcome assessor will be blinded to avoid being biased during outcome assessment.
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypopressive exercises and electrical muscle stimulation (EMS)
Arm Type
Experimental
Arm Description
Women included in this group underwent 24 sessions during 8 weeks (3 days/ week). Treatment will be given for 50 minutes in each session. Electrical muscle stimulation (EMS) will be applied in prone lying before every session of hypopressive exercises (HE). A device will use for muscle stimulation at 7Hz for 15 minutes. The intensity of current will gradually increase from zero to a minimum that can be tolerated by the patient. Two electrodes will place medially to the ischial tuberosity and the remaining two will place on the sacral area.
After a 2-minute interval, the patient will be asked to perform HE in an upright position. For this maneuver, the patient will be instructed to inhale, then breathe to expand the ribcage, and then exhale completely. Hold the breath out before relaxing core and ribcage. Four sets of 10 repetitions with a 3-minute interval between each set will be performed.
Arm Title
Pelvic floor muscle exercises and electrical muscle stimulation (EMS)
Arm Type
Experimental
Arm Description
Women included in this group underwent 24 sessions during 8 weeks (3 days/ week). Treatment will be given for 50 minutes in each session. Electrical muscle stimulation (EMS) will be applied in prone lying before every session of pelvic floor muscle exercises. A device will use for muscle stimulation at 7Hz for 15 minutes. The intensity of current will gradually increase from zero to a minimum that can be tolerated by the patient. Two electrodes will place medially to the ischial tuberosity and the remaining two will place on the sacral area.
After a 2-minute interval, the patient will be asked to perform pelvic floor muscle exercises in a sitting position. The patient is instructed to hold each contraction for 6 seconds, with three to four contractions added on the top. Four sets of 10 repetitions with a 2-minute interval between each set will be performed.
Intervention Type
Other
Intervention Name(s)
Hypopressive exercises
Intervention Description
For hypopressive exercises, the patient will be instructed to inhale, then breathe to expand the ribcage, and then exhale completely. Hold the breath out before relaxing core and ribcage.
Intervention Type
Other
Intervention Name(s)
Pelvic floor exercises
Intervention Description
For pelvic floor exercises, the patient is instructed to hold each contraction for 6 seconds.
Primary Outcome Measure Information:
Title
International Consultation Incontinence Questionnaire Short Form (ICIQ-SF)
Description
ICIQ-SF is a screening tool for incontinence. 4 main items (a total of 6) ask for a rating of symptoms in past four weeks. Item 1 and 2 are demographics so items 3,4,5 are summed for a total score. Using a score value, UI is classified as mild (1-5), moderate (6-12), severe (13-18), very severe (19-21) from a total score ranges from 0-21.
Time Frame
8th week
Title
International Impact Questionnaire, Short Form (IIQ-7)
Description
IIQ-7 is a reliable tool for measuring the impact on quality of life for UI patients. Calculate the mean of all items and then subtract the mean by 1, then multiply by 100/3 (0-100 range).
Time Frame
8th week
Title
Medical, Epidemiologic and Social aspects of Aging Questionnaire (MESA Questionnaire)
Description
It is a reliable and validated tool to evaluate the severity and predominance of stress and urge urinary incontinence. The MESA Questionnaire consists of 15 items total divided into stress (1-9) and urge (10-15) subscales. The total score of urgency (18) and stress (27) is divided into three degrees. For urgency, a score of 1-6 is categorized as mild, 7-12 moderate, and 13-18 as severe. For stress, a score of 1-9 is categorized as mild, 10-18 moderate, and 19-27 as severe. A higher MESA score indicates more frequent symptoms overall ranges from 0-45.
Time Frame
8th week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women aged between 20 to 65 years
Gynecologist and urologist diagnosed patients
Participants not engaged systematically in sports or physical activities(≤ sessions per week, ≤ weeks per week)
Exclusion Criteria:
If participants had hypertension or any serious mental disease
Pregnancy or up to 2 months postpartum
Urge fecal incontinence or vaginal pain
Underwent any physiotherapy for urinary incontinence before
Any kidney disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhmmad Kashif
Organizational Affiliation
Riphah International University
Official's Role
Study Chair
Facility Information:
Facility Name
Riphah International University
City
Faisalābad
State/Province
Punjab
ZIP/Postal Code
3800
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Hypopressive Exercises in Comparison With Routine Pelvic Floor Exercises in Women With Urinary Incontinence
We'll reach out to this number within 24 hrs