Stress Urinary IncontinenceNCT06715813
Additional Effects of Transversus Abdominial Strengthening Along With Pelvic Floor Muscle Strengthening on Stress Urinary Incontinence Among Multiparous Women
A study testing pelvic floor strengthening and Transversus abdominal strengthening in people with Stress Urinary Incontinence, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
SUI stands for stress urinary incontinence. A common condition seen among multiparous women associated with physical strain like bending, coughing, sneezing that put strain on the pelvic floor muscles. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- pelvic floor strengthening and Transversus abdominal strengthening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jun 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age group: multiparous women ( 30-50 yrs)
- females only
- all modes of delivery of childbirth
- diagnosed cases of SUI from fauji foundation hospital.
- patient without any medical contraindications and limitations (Sign and Symptoms of SUI)
- accordances with the michigan incontinence index
Who cannot join
- pregnancy or recent childbirth
- any history of pelvic organ prolapse or surgical intervention
- metabolic diseases, uncontrolled hypertension as well as neurological intervention
- any kind of malignancy in lower abdomen
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 460000
About this study
SUI stands for stress urinary incontinence. A common condition seen among multiparous women associated with physical strain like bending, coughing, sneezing that put strain on the pelvic floor muscles.
- Conditions
- Stress Urinary Incontinence
- Being tested
- pelvic floor strengthening, Transversus abdominal strengthening
- 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 strengtheningProcedure or surgery
pelvic floor strengthening exercises includes :
- breathing exercises,
- kegels exercises
- bridging exercises
- squatting
- Elevator exercises
Transversus abdominal strengtheningProcedure or surgery
core stabilization exercises for 2 weeks like stomach hallowing , dead bugs and pelvic tilt exercises and after 2 weeks dead bug progression, planks
| Study group | Role | What they receive |
|---|---|---|
| pelvic floor strengthening group | Active comparator | Group A that is the control group will includes pelvic floor strengthening exercises. given three times a week on alternate days and session will be given for 4 weeks (protocol) and the retention effect will be given for 8 weeks. Each session will be performed at a moderate intensity , indicated by sustained contractions for 5 seconds initially and then progresively increased to 10 seconds overtime.
pelvic floor strengtheing exercises includes :
1. breathing exercises,
2. kegels exercises
3. bridging exercises
4. squatting
5. Elevator exercises Receives: Procedure: pelvic floor strengthening |
| PFMS + Transversus abdominal strengthening | Experimental | group B includes interventional group which includes core stabilization exercises for 2 weeks like stomach hallowing , dead bugs and pelvic tilt exercises and after 2 weeks dead bug progression, planks and pelvic floor strengthening exercises. Receives: Procedure: pelvic floor strengthening; Procedure: Transversus abdominal strengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
stress urinary incontinence
SUI will be measured using Michigan incontinence index
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start10 Jun 2024
- Primary completion10 Nov 2024
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized controlled trial having two groups. One group will receive SNAGs and the second will receive Sternocleidomastoid Release along with SNAGS. Both groups will be recruited concurrently.
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715813
- Sponsor's protocol ID
- FUI/CTR/2024/54
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Effects of Transversus Abdominial Strengthening Along With Pelvic Floor Muscle Strengthening on Stress Urinary Incontinence Among Multiparous Women
- ClinicalTrials.gov ID
- NCT06715813
- Acronym / sponsor ID
- FUI/CTR/2024/54
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 10 Nov 2024 (actual)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 4 Dec 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.
SUI stands for stress urinary incontinence. A common condition seen among multiparous women associated with physical strain like bending, coughing, sneezing that put strain on the pelvic floor muscles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial having two groups. One group will receive SNAGs and the second will receive Sternocleidomastoid Release along with SNAGS. Both groups will be recruited concurrently.
| Arm | Type | Receives |
|---|---|---|
| pelvic floor strengthening group | Active comparator | Procedure: pelvic floor strengtheningGroup A that is the control group will includes pelvic floor strengthening exercises. given three times a week on alternate days and session will be given for 4 weeks (protocol) and the retention effect will be given for 8 weeks. Each session will be performed at a moderate intensity , indicated by sustained contractions for 5 seconds initially and then progresively increased to 10 seconds overtime. pelvic floor strengtheing exercises includes : 1. breathing exercises, 2. kegels exercises 3. bridging exercises 4. squatting 5. Elevator exercises |
| PFMS + Transversus abdominal strengthening | Experimental | Procedure: pelvic floor strengthening, Procedure: Transversus abdominal strengtheninggroup B includes interventional group which includes core stabilization exercises for 2 weeks like stomach hallowing , dead bugs and pelvic tilt exercises and after 2 weeks dead bug progression, planks and pelvic floor strengthening exercises. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age group: multiparous women ( 30-50 yrs)
- females only
- all modes of delivery of childbirth
- diagnosed cases of SUI from fauji foundation hospital.
- patient without any medical contraindications and limitations (Sign and Symptoms of SUI)
Key exclusion criteria (4 listed)
- pregnancy or recent childbirth
- any history of pelvic organ prolapse or surgical intervention
- metabolic diseases, uncontrolled hypertension as well as neurological intervention
- any kind of malignancy in lower abdomen
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 strengtheningpelvic floor strengthening exercises includes : 1. breathing exercises, 2. kegels exercises 3. bridging exercises 4. squatting 5. Elevator exercises | Procedure or surgery | PFMS + Transversus abdominal strengthening, pelvic floor strengthening group |
| Transversus abdominal strengtheningcore stabilization exercises for 2 weeks like stomach hallowing , dead bugs and pelvic tilt exercises and after 2 weeks dead bug progression, planks | Procedure or surgery | PFMS + Transversus abdominal strengthening |
Primary outcome
stress urinary incontinence
Time frame: 8 weeks
SUI will be measured using Michigan incontinence index
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pelvic floor strengthening and Transversus abdominal strengthening in people with Stress Urinary Incontinence, run by Foundation University Islamabad at 1 site in Pakistan.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2024. 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 Pakistan. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
stress urinary incontinence (time frame: 8 weeks). 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 4 Dec 2024.