Female Stress Urinary IncontinencePhase 2NCT06599190
Effect Of Abdominal Hypopressive Training On Stress Urinary Incontinence
A Phase 2 study testing pelvic floor exercises, nutritional instructions and abdominal hypopressive exercises, pelvic floor exercises, nutritional instructions in people with Female Stress Urinary Incontinence, run by Badr University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Stress Urinary Incontinence
- What is being tested?
- pelvic floor exercises, nutritional instructions and abdominal hypopressive exercises, pelvic floor exercises, nutritional instructions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2024to 22 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- The female athlete will be excluded if they had:
- Urinary tract infection.
- Family history of genito-urinary tract cancer.
- Diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Abdominal Hypopressive Training On Stress Urinary IncontinenceIn Female Athletes
Fifty female athletes suffering from stress incontinence (SUI) will participate in this study. They will be selected from El Zohour Club, New Cairo City.
Read the detailed description
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.
Before data collection, the purpose and procedures will be fully explained to the females. Informed consent will be obtained from each female. Each female will be evaluated following a standard protocol.
- Conditions
- Female Stress Urinary Incontinence
- Being tested
- pelvic floor exercises, nutritional instructions, abdominal hypopressive exercises, pelvic floor exercises, nutritional instructions
- Keywords
- stress incontinence, and female athelete
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic floor exercises, nutritional instructionsOther
They will receive nutritional instructions and pelvic floor muscle exercises three sessions/week for 3 months.
abdominal hypopressive exercises, pelvic floor exercises, nutritional instructionsOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: abdominal hypopressive exercises, pelvic floor exercises, nutritional instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (1)
Assessment of symptoms and health related quality of life
The ICIQ-SF will be used in assessment of each female in both groups. It is used to measure severity and impact of UI on the quality of life in women. The ICIQ-SF is formed of six items of which four main items ask for rating of UI symptoms in the past 4 weeks. A score of zero means no leakage of urine and no affection on quality of life. (Question 1): quantifies the frequency of urinary leaking, (question 2): evaluates the amount of leaking and (question 3): how much the urinary incontinence interferes with everyday life (Hilton and Robinson, 2011). The scores for items 3, 4 and 5 are taken for the final ICIQ-SF score. Items 1 and 2 are demographic and the final item is a self-diagnostic item for the type of UI. ICIQ- SF (range 0-21) is given four scoring categories: slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Aug 2024
- Primary completion20 Nov 2024
- Study completion22 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Doaa Saeed Mohamed, Badr University
- Investigators
- Abeer ElDeeb, Professor, Study chair, professor doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599190
- Sponsor's protocol ID
- P.T.REC/012/004947
- Status last verified
- Mar 2025
- First submitted
- 18 Aug 2024
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not sharing
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Abdominal Hypopressive Training On Stress Urinary IncontinenceIn Female Athletes
- ClinicalTrials.gov ID
- NCT06599190
- Acronym / sponsor ID
- P.T.REC/012/004947
- Conditions
- Female Stress Urinary Incontinence
- Keywords
- stress incontinence, and female athelete
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 22 Dec 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fifty female athletes suffering from stress incontinence (SUI) will participate in this study. They will be selected from El Zohour Club, New Cairo City.
Detailed description
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.
Before data collection, the purpose and procedures will be fully explained to the females. Informed consent will be obtained from each female. Each female will be evaluated following a standard protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group (A) (Control group) | Active comparator | Other: pelvic floor exercises, nutritional instructionsconsists of 25 female athletes. They will receive nutritional instructions and pelvic floor muscle exercises three sessions/week for 3 months. |
| Group (B) (Study group) | Experimental | Other: abdominal hypopressive exercises, pelvic floor exercises, nutritional instructionsconsists 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. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Urinary tract infection.
- Family history of genito-urinary tract cancer.
- Diabetes mellitus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pelvic floor exercises, nutritional instructionsThey will receive nutritional instructions and pelvic floor muscle exercises three sessions/week for 3 months. | Other | Group (A) (Control group) |
| abdominal hypopressive exercises, pelvic floor exercises, nutritional instructionsconsists 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 | Group (B) (Study group) |
Primary outcome
Assessment of urine loss
Time frame: 24 hours pad test for12 weeks
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.
assesment of pelvic floor muscle contraction and tonning
Time frame: 12 weeks
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.
1 secondary outcome
Assessment of symptoms and health related quality of life
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No. not sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abeer ElDeeb, Professor study chair
professor doctor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pelvic floor exercises, nutritional instructions and abdominal hypopressive exercises, pelvic floor exercises, nutritional instructions in people with Female Stress Urinary Incontinence, run by Badr University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of urine loss (time frame: 24 hours pad test for12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.