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

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Other: Hypopressive exercises; Other: Pelvic floor exercises

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Faisalābad, Punjab, Pakistan, 3800
      • Riphah International University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypopressive exercises and electrical muscle stimulation (EMS); 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.	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.
Experimental: Pelvic floor muscle exercises and electrical muscle stimulation (EMS); 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.	Other: Pelvic floor exercises; For pelvic floor exercises, the patient is instructed to hold each contraction for 6 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Study Chair: Muhmmad Kashif, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Actual): February 20, 2022
• Study Completion (Actual): February 20, 2022

Study Registration Dates

• First Submitted: February 4, 2022
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Urinary Incontinence; Pelvic floor exercises; Hypopressive exercises
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: REC-FSD-00282

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No