Effects of Hypopressive Exercises in Comparison With Routine Pelvic Floor Exercises in Women With Urinary Incontinence

Urinary Incontinence Clinical Trial

Official title:

Effects of Hypopressive Exercises in Comparison With Routine Pelvic Floor Exercises in Women With Urinary Incontinence: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05239949
• Other study ID #: REC-FSD-00282
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: February 20, 2022

Study information

• Verified date: May 2022
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 20, 2022
• Est. primary completion date: February 20, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Other:
• Hypopressive exercises
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.
• Pelvic floor exercises
For pelvic floor exercises, the patient is instructed to hold each contraction for 6 seconds.

Locations

Country	Name	City	State
Pakistan	Riphah International University	Faisalabad	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8th week
Primary	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).	8th week
Primary	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.	8th week