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

Not Applicable

Completed

• Conditions: Urinary Incontinence
• Interventions: Other: Hypopressive exercises; Other: Pelvic floor exercises

• Registration Number: NCT05239949
• Lead Sponsor: Riphah International University

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.

Study Timeline

• Study Start: 2021-03-15
• Study First Submitted: 2022-02-04
• Study First Submitted QC: 2022-02-04
• Study First Posted: 2022-02-15
• Primary Completion: 2022-02-20
• Study Completion: 2022-02-20
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-31
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypopressive exercises and electrical muscle stimulation (EMS)	Hypopressive exercises	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.
Pelvic floor muscle exercises and electrical muscle stimulation (EMS)	Pelvic floor exercises	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.

Primary Outcome Measures

Name	Time	Method
Medical, Epidemiologic and Social aspects of Aging Questionnaire (MESA Questionnaire)	8th week	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.
International Consultation Incontinence Questionnaire Short Form (ICIQ-SF)	8th week	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)	8th week	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).

Trial Locations

Locations (1)

Riphah International University; 🇵🇰 Faisalābad, Punjab, Pakistan