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CompletedNCT05239949Updated Jun 1, 2022

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

An interventional study of Hypopressive exercises and Pelvic floor exercises in Urinary Incontinence, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to female participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-06-01.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Mar 2021, registered Feb 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Urinary Incontinence

Keywords

  • Urinary Incontinence
  • Pelvic floor exercises
  • Hypopressive exercises
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's enrollment of 20 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherHypopressive 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.

  • OtherPelvic floor exercises

    For pelvic floor exercises, the patient is instructed to hold each contraction for 6 seconds.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8th week

  2. 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).

    Time frame: 8th week

  3. 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.

    Time frame: 8th week

07

Study locations

1 site
  • Riphah International University
    Faisalābad, Punjab 3800, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05239949
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Feb 15, 2022
Start date
Mar 15, 2021
Primary completion
Feb 20, 2022
Completion
Feb 20, 2022
Last update
Jun 1, 2022

Study contacts

Muhmmad Kashif
study chair · Riphah International University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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