Urinary IncontinenceNCT07037160
Effectiveness of Foam RE and KE for Urinary Incontinence in Postpartum Women With Diastasis Recti
A study testing Kegel exercises and Kegel exercises with Foam Rolling in people with Urinary Incontinence, run by Superior University at 1 site in Pakistan.
Trial summary
The objective of the study will be to assess the efficacy of foam rolling alone and combination treatment of foam rolling and Kegel exercises in alleviating urinary incontinence among postpartum women with diastasis recti. Read more about this study
- Who is it for?
- Ages 20 to 30 years, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Kegel exercises and Kegel exercises with Foam Rolling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Mar 2025to 1 Sep 2025
- 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 20 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females with age 20 to 35 years
- Females with vaginal delivery
- Non obese females
- Females diagnosed with diastasis recti and urinary incontinence
Who cannot join
- Females with mental disorders
- Females who take di-uretic medications
- Females with malignant tumors
- Patients with urinary tract infection
- Patients with a history of pelvic surgery
- Patients with cognitive dysfunction
- Female with gynecological conditions or diseases that may affect the investigation results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Foam Rolling Exercise and Kegel Exercise for Urinary Incontinence in Postpartum Women With Diastasis Recti
The objective of the study will be to assess the efficacy of foam rolling alone and combination treatment of foam rolling and Kegel exercises in alleviating urinary incontinence among postpartum women with diastasis recti.
The data will be collected from 60 enrolled postpartum females with diastasis recti to evaluate the effectiveness of foam rolling alone compared to foam rolling and Kegel exercises in improving urinary incontinence. The data will be collected using urogenital distress inventory (UDI).
Read the detailed description
Urinary incontinence is a common issue among postpartum women, often linked to diastasis recti, which weakens core and pelvic floor muscles. Despite its prevalence, effective combined treatment approaches remain limited. Foam rolling may enhance muscle function, while Kegel exercises strengthen the pelvic floor. This study investigates their combined effectiveness in managing urinary incontinence among postpartum women with diastasis recti, compared to Kegel exercises alone.
- Conditions
- Urinary Incontinence
- Being tested
- Kegel exercises, Kegel exercises with Foam Rolling
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kegel exercisesCombination product
Kegel exercises, also known as pelvic floor exercises, involve contracting and relaxing the muscles of the pelvic floor to strengthen them. These exercises can help improve urinary and fecal continence, potentially enhance sexual function, and are recommended for both men and women.
Kegel exercises with Foam RollingCombination product
Foam rolling can be a helpful tool to prepare for or complement Kegel exercises by releasing tension in surrounding muscles and improving overall pelvic floor function. Foam rolling can help address tight muscles in the hips and lower back that can contribute to pelvic floor dysfunction. By releasing these tight areas, foam rolling can allow for better engagement and control of the pelvic floor muscles during Kegel exercises.
| Study group | Role | What they receive |
|---|---|---|
| Kegel exercises | Experimental | Not described Receives: Combination Product: Kegel exercises |
| Kegel exercises with Foam Rolling | Experimental | Not described Receives: Combination Product: Kegel exercises with Foam Rolling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urogenital Distress Inventory (UDI-6)
The Urogenital Distress Inventory (UDI-6) is a questionnaire used to assess the impact of urinary symptoms on a woman's quality of life. It consists of six questions, each with four possible responses ranging from "not at all" to "greatly," and the responses are scored from 0 to 3 respectively. The scores for each question are summed, and then the total is multiplied by 33.3 to scale the score to a range of 0-100. Higher scores indicate a greater degree of distress caused by urinary symptoms
Measured: 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start4 Mar 2025
- Primary completion1 Jun 2025
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037160
- Sponsor's protocol ID
- DPT/Batch-Fall20/1008
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Foam Rolling Exercise and Kegel Exercise for Urinary Incontinence in Postpartum Women With Diastasis Recti
- ClinicalTrials.gov ID
- NCT07037160
- Acronym / sponsor ID
- DPT/Batch-Fall20/1008
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 25 Jun 2025 (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.
The objective of the study will be to assess the efficacy of foam rolling alone and combination treatment of foam rolling and Kegel exercises in alleviating urinary incontinence among postpartum women with diastasis recti.
The data will be collected from 60 enrolled postpartum females with diastasis recti to evaluate the effectiveness of foam rolling alone compared to foam rolling and Kegel exercises in improving urinary incontinence. The data will be collected using urogenital distress inventory (UDI).
Detailed description
Urinary incontinence is a common issue among postpartum women, often linked to diastasis recti, which weakens core and pelvic floor muscles. Despite its prevalence, effective combined treatment approaches remain limited. Foam rolling may enhance muscle function, while Kegel exercises strengthen the pelvic floor. This study investigates their combined effectiveness in managing urinary incontinence among postpartum women with diastasis recti, compared to Kegel exercises alone.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kegel exercises | Experimental | Combination Product: Kegel exercises |
| Kegel exercises with Foam Rolling | Experimental | Combination Product: Kegel exercises with Foam Rolling |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Females with age 20 to 35 years
- Females with vaginal delivery
- Non obese females
- Females diagnosed with diastasis recti and urinary incontinence
Key exclusion criteria (7 listed)
- Females with mental disorders
- Females who take di-uretic medications
- Females with malignant tumors
- Patients with urinary tract infection
- Patients with a history of pelvic surgery
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 |
|---|---|---|
| Kegel exercisesKegel exercises, also known as pelvic floor exercises, involve contracting and relaxing the muscles of the pelvic floor to strengthen them. These exercises can help improve urinary and fecal continence, potentially enhance sexual function, and are recommended for both men and women. | Combination product | Kegel exercises |
| Kegel exercises with Foam RollingFoam rolling can be a helpful tool to prepare for or complement Kegel exercises by releasing tension in surrounding muscles and improving overall pelvic floor function. Foam rolling can help address tight muscles in the hips and lower back that can contribute to pelvic floor dysfunction. By releasing these tight areas, foam rolling can allow for better engagement and control of the pelvic floor muscles during Kegel exercises. | Combination product | Kegel exercises with Foam Rolling |
Primary outcome
Urogenital Distress Inventory (UDI-6)
Time frame: 6 Month
The Urogenital Distress Inventory (UDI-6) is a questionnaire used to assess the impact of urinary symptoms on a woman's quality of life. It consists of six questions, each with four possible responses ranging from "not at all" to "greatly," and the responses are scored from 0 to 3 respectively. The scores for each question are summed, and then the total is multiplied by 33.3 to scale the score to a range of 0-100. Higher scores indicate a greater degree of distress caused by urinary symptoms
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 25 Jun 2025.
- Individual participant dataSharing planned: No
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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 Kegel exercises and Kegel exercises with Foam Rolling in people with Urinary Incontinence, run by Superior University 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 4 inclusion and 7 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 25 Jun 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 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?
Urogenital Distress Inventory (UDI-6) (time frame: 6 Month). 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 25 Jun 2025.