Stress Urinary IncontinenceNCT04253925
Effect of Global Postural Correction Exercises on Stress Urinary Incontinence During Pregnancy: A Randomized Controlled Trial
A study testing Kegel exercises in people with Stress Urinary Incontinence, run by Cairo University.
Trial summary
Background: One of the many consequences of pregnancy that may negatively affect a woman's quality of life is stress urinary incontinence caused by activities of daily living especially those associated with increased intraabdominal pressure. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Kegel exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Dec 2018
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Forty primigravida women with singleton fetus in their third trimester and diagnosed with pregnancy related SUI participated in this study.
- All participants suffered from a mild to moderate grade of SUI identified by clinical grading (Ingelman-Sundberg) (Wlazlak et al., 2015) as follows: Grade I (mild), the leakage of urine occurs on straining; and grade II (moderate), the leakage occurs following abrupt movement
Who cannot join
- Females were excluded from the study if they had severe grade SUI; infections in their lower urinary tract; neurological conditions; gestational diabetes; and chronic chest diseases. Females who smoked, used any medications or medical/surgical interventions for SUI, or who suffered any other type of urinary incontinence were also excluded from the study
About this study
Background: One of the many consequences of pregnancy that may negatively affect a woman's quality of life is stress urinary incontinence caused by activities of daily living especially those associated with increased intraabdominal pressure. Objective: This study aimed to investigate the effect of global postural correction exercises on stress urinary incontinence among pregnant women. Participants and Methods: Forty primigravida women (aged between 30-39 years), with a single fetus, diagnosed with stress urinary incontinence participated in the study. Participants were assigned randomly into two groups: Study group (group A; n=20) and control group (group B; n=20). The participants were tested twice, before and after a 12-week period, during which group A received global postural correction exercises in addition to Kegel exercises, while group B performed only Kegel exercises. A perineometer was used to evaluate the change in vaginal squeeze pressure both before and after conducting the study. Urogenital Distress Inventory Questionnaire (UDI-6) was used to assess changes in incontinence severity symptoms.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Kegel exercises
- Keywords
- Kegel exercise, Postural Correction, Stress Urinary Incontinence
- 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.
Kegel exercisesOther
global postural correction exercises
| Study group | Role | What they receive |
|---|---|---|
| global postural correction exercises | Experimental | global postural correction exercises in addition to Kegel exercises Receives: Other: Kegel exercises |
| Kegel exercises | Active comparator | only Kegel exercises Receives: Other: Kegel exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
strength of pelvic floor muscle
Measured: change from Baseline strength of pelvic floor muscle at 12-weeks
Secondary outcomes (1)
Urogenital Distress Inventory Questionnaire
Measured: change from Baseline Urogenital Distress Inventory Questionnaire (UDI-6) at 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Jan 2017
- Primary completion2 Jan 2018
- Study completion1 Dec 2018
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 Cairo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HAhmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253925
- Sponsor's protocol ID
- P.T.REC/012/00976
- Status last verified
- Jan 2020
- First submitted
- 31 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Global Postural Correction Exercises on Stress Urinary Incontinence During Pregnancy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04253925
- Acronym / sponsor ID
- P.T.REC/012/00976
- Conditions
- Stress Urinary Incontinence
- Keywords
- Kegel exercise, Postural Correction, Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 2 Jan 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 5 Feb 2020 (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.
Background: One of the many consequences of pregnancy that may negatively affect a woman's quality of life is stress urinary incontinence caused by activities of daily living especially those associated with increased intraabdominal pressure. Objective: This study aimed to investigate the effect of global postural correction exercises on stress urinary incontinence among pregnant women. Participants and Methods: Forty primigravida women (aged between 30-39 years), with a single fetus, diagnosed with stress urinary incontinence participated in the study. Participants were assigned randomly into two groups: Study group (group A; n=20) and control group (group B; n=20). The participants were tested twice, before and after a 12-week period, during which group A received global postural correction exercises in addition to Kegel exercises, while group B performed only Kegel exercises. A perineometer was used to evaluate the change in vaginal squeeze pressure both before and after conducting the study. Urogenital Distress Inventory Questionnaire (UDI-6) was used to assess changes in incontinence severity symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| global postural correction exercises | Experimental | Other: Kegel exercisesglobal postural correction exercises in addition to Kegel exercises |
| Kegel exercises | Active comparator | Other: Kegel exercisesonly Kegel exercises |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Forty primigravida women with singleton fetus in their third trimester and diagnosed with pregnancy related SUI participated in this study.
- All participants suffered from a mild to moderate grade of SUI identified by clinical grading (Ingelman-Sundberg) (Wlazlak et al., 2015) as follows: Grade I (mild), the leakage of urine occurs on straining; and grade II (moderate), the leakage occurs following abrupt movement
Key exclusion criteria (1 listed)
- Females were excluded from the study if they had severe grade SUI; infections in their lower urinary tract; neurological conditions; gestational diabetes; and chronic chest diseases. Females who smoked, used any medications or medical/surgical interventions for SUI, or who suffered any other type of urinary incontinence were also excluded from the study
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 exercisesglobal postural correction exercises | Other | Kegel exercises, global postural correction exercises |
Primary outcome
strength of pelvic floor muscle
Time frame: change from Baseline strength of pelvic floor muscle at 12-weeks
1 secondary outcome
Urogenital Distress Inventory Questionnaire
Time frame: change from Baseline Urogenital Distress Inventory Questionnaire (UDI-6) at 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 5 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Kegel exercises in people with Stress Urinary Incontinence, run by Cairo University.
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 2 inclusion and 1 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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
strength of pelvic floor muscle (time frame: change from Baseline strength of pelvic floor muscle at 12-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 5 Feb 2020.