Swiss ball and diaphragmatic breathing program to reduce urinary leakage in pregnant women
Combined Effects of Swiss Ball Exercises and Diaphragmatic Breathing on Stress Urinary Incontinence, Pelvic Floor Muscle Strength and Quality of Life in Pregnant Females.
This program will test whether adding Swiss ball exercises and diaphragmatic breathing to Kegel exercises helps pregnant women aged 20–40 with mild-to-moderate stress urinary incontinence reduce leakage and improve quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | Female |
| Sponsor | Riphah International University Academic / other |
| Locations | 1 site (Lahore, Punjab Province) |
| Trial ID | NCT07520396 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial in Lahore will enroll 42 pregnant women with mild-to-moderate stress urinary incontinence and weak pelvic floor muscles, randomizing them to a combined Swiss ball plus diaphragmatic breathing and Kegel exercise program or to a comparison group. The intervention group will follow a structured regimen of Swiss ball exercises combined with diaphragmatic breathing and pelvic floor (Kegel) exercises, while the comparison group will receive the usual pelvic floor exercise guidance. Primary outcomes include pelvic floor muscle strength, frequency of stress urinary leakage, and pregnancy-related quality of life, with measurement over the planned study period. Recruitment will use non-probability sampling at Ittefaq Hospital and Zia Hospital in Lahore and the study is expected to be completed within about 10 months after protocol approval.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 20–40 with a singleton pregnancy, diagnosed mild-to-moderate stress urinary incontinence, and demonstrable weak pelvic floor muscles without contraindications such as placenta previa or active infection.
Not a fit: Women who are not pregnant or who have conditions like placenta previa, active urinary tract infection, preterm labor risk, pelvic organ prolapse, or prior hysterectomy are excluded and are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the combined exercise program could reduce episodes of stress urinary incontinence and improve pelvic floor strength and quality of life during pregnancy.
How similar studies have performed: Previous pelvic floor muscle training studies, including programs using stability balls and diaphragmatic breathing, have reported modest improvements in pelvic floor strength and urinary symptoms, though combined protocols specifically in pregnancy are less extensively studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lahore, Punjab Province
- Itefaq Hospital and Zia Hospital — Lahore, Punjab Province, Pakistan (Recruiting)
Study contacts
- Principal investigator: Masooma Saleem, MSPT WH — Riphah International University
- Study coordinator: imran amjad, phd
- Email: imran.amjad@riphah.edu.pk
- Phone: 03324390125
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.