Effect Of Abdominal Hypopressive Training On Stress Urinary Incontinence

NCT06599190 | Completed Phase 2 DMC

• 1 other identifier: P.T.REC/012/004947
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Fifty female athletes suffering from stress incontinence (SUI) will participate in this study. They will be selected from El Zohour Club, New Cairo City.

Conditions

Female Stress Urinary Incontinence

Keywords

stress incontinence, and female athelete

Outcome Measures

Primary Outcomes (2)

• Assessment of urine loss

  Pad testing will be used to quantify the volume of urine loss by weighing an absorbent pad before and after some type of leakage provocation. The test will start with weighting clean empty pad in grams. Then, it will be used until next time and weighted again. The weight of the used pad will be subtracted from the weight of the empty pad so the net result will determine the amount of leakage.

  24 hours pad test for12 weeks

• assesment of pelvic floor muscle contraction and tonning

  The measurements will be taken in crock-lying position with a full bladder, neutral lumbar spine. The ultrasound transducer will be inserted transversely directly superior to the symphysis pubis, probe is tilted 60 degrees from vertical (Arab, 2010). Every female will perform 3 maximal PFM contractions so that displacement of the bladder wall, because of a PFM contraction, could be measured.

  12 weeks

Secondary Outcomes (1)

• Assessment of symptoms and health related quality of life

  12 weeks

Study Arms (2)

Group (A) (Control group)

ACTIVE COMPARATOR

consists of 25 female athletes. They will receive nutritional instructions and pelvic floor muscle exercises three sessions/week for 3 months.

Other: pelvic floor exercises, nutritional instructions

Group (B) (Study group)

EXPERIMENTAL

consists of 25 female athletes. They will receive the same treatment for the control group and abdominal hypopressive exercises three sessions/week of 30 mins per week for 3 months.

Other: abdominal hypopressive exercises, pelvic floor exercises, nutritional instructions

Interventions

pelvic floor exercises, nutritional instructions OTHER

They will receive nutritional instructions and pelvic floor muscle exercises three sessions/week for 3 months.

Group (A) (Control group)

abdominal hypopressive exercises, pelvic floor exercises, nutritional instructions OTHER

consists of 25 female athletes. They will receive the same treatment for the control group and abdominal hypopressive exercises three sessions/week of 30 mins per week for 3 months.

Group (B) (Study group)

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female athletes suffering from SUI.
• They will be diagnosed with SUI using bladder stress test.
• Their ages will range from 14-18 years old.
• Their body mass index (BMI) will range from 18.5-24.9 kg/m2.
• They are single females.

You may not qualify if:

• The female athlete will be excluded if they had:
• Urinary tract infection.
• Family history of genito-urinary tract cancer.
• Diabetes mellitus.

Sponsors & Collaborators

• Badr University: lead
• Cairo University: collaborator

Study Sites (1)

El Zohour Club

New Cairo, Cairo Governorate, 470001, Egypt

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Abeer ElDeeb, Professor

  professor doctor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: single
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: They will be randomly distributed into 2 groups equal in numbers: Group (A) (Control group) consists of 25 female athletes. They will receive nutritional instructions and pelvic floor muscle exercises three sessions/week for 3 months. Group (B) (Study group) consists of 25 female athletes. They will receive the same treatment for the control group and abdominal hypopressive exercises three sessions/week of 30 mins per week for 3 months.

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: September 19, 2024
• Study Start: August 20, 2024
• Primary Completion: November 20, 2024
• Study Completion: December 22, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)