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Clinical Trials/NCT07520396
NCT07520396
Recruiting
Not Applicable

Combined Effects of Swiss Ball Exercises and Diaphragmatic Breathing on Stress Urinary Incontinence, Pelvic Floor Muscle Strength and Quality of Life in Pregnant Females.

Riphah International University1 site in 1 country42 target enrollmentStarted: August 31, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
42
Locations
1
Primary Endpoint
Incontinence questionnaire

Overview

Brief Summary

30 to 60 percent of the pregnant females experience stress urinary incontinence depending on various factors like trimester, parity and body weight. Stress urinary incontinence is a common yet often underreported condition affecting pregnant women, characterized by involuntary leakage of urine during physical activities such as coughing, sneezing, or exercising. Stress urinary incontinence majorly occurs due to increased intra-abdominal pressure and weakened pelvic floor muscles which are further strained during pregnancy. Despite its impact on quality of life, awareness and management remains inadequate. Strengthening the pelvic floor muscles plays a critical role in managing stress urinary incontinence and Swiss ball exercises have emerged as an effective and low impact method to improve core stability and pelvic floor muscle strength. These exercises engage deep abdominal and pelvic muscles in a functional and dynamic way, potentially enhancing both physical and psychological well-being during pregnancy.

. The study will be conducted as a randomized control trial involving females with stress urinary incontinence in Zia Hospital Lahore and Ittefaq Hospital Lahore. The study will be completed within 10 months of synopsis approval. A non-probability sampling technique will be employed and 42 patients will be enrolled after randomization. Participants will be divided into two groups. Group A will undergo a structured program involving Swiss ball exercises combined with diaphragmatic breathing. Group B will receive Swiss ball exercises without diaphragmatic breathing. Kegel exercises will be considered the baseline treatment. Outcome measures will include syptoms of stress urinary incontinence (using International Consultation Incontinence Questionnaire), pelvic floor muscle strength (assessed through standardized tools i.e. Modified Oxford Scale) and self-reported quality of life (using validated questionnaires i.e. King's Health Questionnaire). The data collected will be analyzed using IBM SPSS statistics version 25.

Detailed Description

30 to 60 percent of the pregnant females experience stress urinary incontinence depending on various factors like trimester, parity and body weight. Stress urinary incontinence is a common yet often underreported condition affecting pregnant women, characterized by involuntary leakage of urine during physical activities such as coughing, sneezing, or exercising. Stress urinary incontinence majorly occurs due to increased intra-abdominal pressure and weakened pelvic floor muscles which are further strained during pregnancy. Despite its impact on quality of life, awareness and management remains inadequate. Strengthening the pelvic floor muscles plays a critical role in managing stress urinary incontinence and Swiss ball exercises have emerged as an effective and low impact method to improve core stability and pelvic floor muscle strength. These exercises engage deep abdominal and pelvic muscles in a functional and dynamic way, potentially enhancing both physical and psychological well-being during pregnancy.

. The study will be conducted as a randomized control trial involving females with stress urinary incontinence in Zia Hospital Lahore and Ittefaq Hospital Lahore. The study will be completed within 10 months of synopsis approval. A non-probability sampling technique will be employed and 42 patients will be enrolled after randomization. Participants will be divided into two groups. Group A will undergo a structured program involving Swiss ball exercises combined with diaphragmatic breathing. Group B will receive Swiss ball exercises without diaphragmatic breathing. Kegel exercises will be considered the baseline treatment. Outcome measures will include syptoms of stress urinary incontinence (using International Consultation Incontinence Questionnaire), pelvic floor muscle strength (assessed through standardized tools i.e. Modified Oxford Scale) and self-reported quality of life (using validated questionnaires i.e. King's Health Questionnaire). The data collected will be analyzed using IBM SPSS statistics version 25.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
20 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • • Females with singleton pregnancy
  • Females with urinary incontinence
  • Age range between 20-40
  • Females with diagnosed with mild to moderate stress urinary incontinence
  • Females with weak pelvic floor muscles

Exclusion Criteria

  • • Females who are not pregnant
  • Females who have had any previous history of hysterectomy
  • Females with placenta previa
  • Females with UTI
  • Females with preterm labor
  • Females with pelvic organ prolapse

Arms & Interventions

Diaphragmatic breathing

Experimental

There will be total 12 sessions carried for 6 weeks. 3-4 sessions will be given per week. In each session, patients will be exposed to moderate intensity Swiss ball exercises will include, Swiss ball wall squats, pelvic tilts, bridging with legs on Swiss ball and ball squeeze. Each exercise will be carried out in 3 sets of 10 repetitions for 20-25 minutes session. After each set, patient will be asked to follow the diaphragmatic breathing by deep inhaling through nose and exhaling with pursed lips for 3-4 seconds. During the breathing, patient will hold onto pelvic contractions kept on for 10-15 minutes.

Intervention: kegels exercises (Other)

Diaphragmatic breathing

Experimental

There will be total 12 sessions carried for 6 weeks. 3-4 sessions will be given per week. In each session, patients will be exposed to moderate intensity Swiss ball exercises will include, Swiss ball wall squats, pelvic tilts, bridging with legs on Swiss ball and ball squeeze. Each exercise will be carried out in 3 sets of 10 repetitions for 20-25 minutes session. After each set, patient will be asked to follow the diaphragmatic breathing by deep inhaling through nose and exhaling with pursed lips for 3-4 seconds. During the breathing, patient will hold onto pelvic contractions kept on for 10-15 minutes.

Intervention: Diaphragmatic breathing (Other)

swiss ball exercises

Active Comparator

There will be total 12 sessions carried for 6 weeks. 3-4 sessions will be given per week. In each session, patients will be exposed to moderate intensity Swiss ball exercises will include, Swiss ball wall squats, pelvic tilts, bridging with legs on Swiss ball and ball squeeze. Each exercise will be carried out in 3 sets of 10 repetitions for 20-25 minutes session.

Intervention: kegels exercises (Other)

Outcomes

Primary Outcomes

Incontinence questionnaire

Time Frame: 8 weeks

. ICIQ-UI SF is used for measuring frequency, volume and impact of urinary leakage. Also, that this tool is free for clinical and small-scale research use; larger studies or commercial entities may require permission. The scoring system ranges from 0-21 based on symptom, frequency or volume of the leaked urine.

Kings health questionnaire

Time Frame: 8 weeks

KHQ is considered to be an easy tool to measure the quality of life affected by following 9 domains.

Perinometer or manual muscle testing

Time Frame: 8 weeks

A perineometer is a medical which measures vaginal pressure during pelvic floor muscle contraction, giving a quantitative assessment. It is a precise and repeatable assessment protocol and provides visual feedback during training.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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