Stress Urinary IncontinenceNCT06265896
Effect of Kinesiotaping on Activation of Abdominal Muscles in Female Patients With Stress Urinary Incontinence
A study testing Kinesio taping and Pelvic floor exercise training in people with Stress Urinary Incontinence, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to evaluate the effect of kinesiotaping on activation of abdominopelvic cavity for management of stress urinary incontinence females' patients. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Kinesio taping and Pelvic floor exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 1 Jun 2024
- 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 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women suffering from mild to moderate stress urinary incontinence, clinically diagnosed by the gynecologist.
- Their ages will be ranged from 30-50 years old.
- Their body mass index (BMI) will be ranged from (20-25 kg/m2).
- They shouldn't have any musculoskeletal or neurological disorders.
Who cannot join
- Current pregnancy.
- Malignant condition
- History of acute infection
- Neurological problem
- Mental problem to prevent evaluation and cooperation
- Having allergies to kinesiotaping
- Having uncontrolled metabolic diseases like diabetes and thyroid disease.
- Athletic females
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cairo University
Giza
Mai N. Mamdouh, M.Sc. Student, 01014924808, G01014924808@gmail.com
Dalia M. Kamel, Prof., 01273990045, dr-daliakamel@cu.edu.eg
About this study
This study will be conducted to evaluate the effect of kinesiotaping on activation of abdominopelvic cavity for management of stress urinary incontinence females' patients.
Read the detailed description
Stress urinary incontinence, the involuntary leakage of urine during exercise or certain movements, is a common pelvic floor disorder that can negatively impact quality of life. Urinary incontinence is associated with reduced physical, social, and mental well-being. While alternative exercise regimens have been proposed, It was concluded there is insufficient evidence they reduce leakage in women with stress urinary incontinence.
Kinesio taping is a rehabilitative technique that provides support and stability to muscles using elastic tape. Kinesio tape has no drugs/chemicals and allows normal skin function.
Limited studies have shown taping specific abdominal areas can stimulate skin-organ reflexes and improve pelvic organ function through interactions between the pelvis, pelvic floor muscles, and synergists. Therefore, could suggested that KT application on abdominopelvic cavity might be emerged as a conservative treatment option for urinary incontinence There were couple of previous research investigated the KT efficacy on treating bladder over activity with promising results of improvements. Till now, there is no previous study illustrating the effect of kinesio taping on abdominopelvic cavity in stress urinary incontinence females. So, this study will be the first one in this issue. Therefore, it will have valuable benefits in physical therapy field and scientific research.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Kinesio taping, Pelvic floor exercise training
- Keywords
- Kinesiotaping, Abdominal Muscles, Female Patients, 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.
Kinesio tapingOther
Tape will be applied on rectus abdominis muscles using muscles facilitation technique from origin to insertion of muscle with a tension between 15-35%. Band will start on symphysis pubis with no tension and then women make stretch on the abdominal region by deep abdominal inspiration and will end at xiphoid process. Tape will be applied on the right and left external oblique muscles; the procedure will start without tension from bottom and of 6-12 ribs, then the hip will be placed in flexion and rotation to opposite direction and the tape will be attached to pubic bone with tension between 15-35%. Finally, the tape will be performed on the right and left internal oblique muscles; the procedure will start without tension from anterior superior iliac spine and then the hip will be placed in extension position and the tape will be attached to lower 4 ribs and linea alba with tension between 15-35%.
Pelvic floor exercise trainingOther
The intervention will be applied by a trained physical therapist. First of all, each participant will be instructed to relax thighs, bottom and abdomen musculature, then squeeze pelvic floor muscles 'focus on tightening without flexing abdomen, thighs or buttocks- avoid holding breath' 10 repetitions, 3 to 5 times a day (morning, afternoon, and night). Rest for 4 seconds and then repeat each contraction. Build up pelvic floor musculatures strength until each participant be able to do 10 slow contractions each time, holding them for 10 seconds each with rests of 4 seconds in between. Then do not hold your breath or tighten your stomach, bottom or thigh muscles at the same time. Will instruct participants to try holding each squeeze for a few seconds.
| Study group | Role | What they receive |
|---|---|---|
| Kinesio taping +Pelvic floor exercise training | Experimental | They will be treated by Elastic Kinesio-tape of (K-Active) brand which will be applied over abdomen, which will be changed every 3 days and this will be maintained along four weeks, plus conventional pelvic floor exercises; 30 minutes, 3 times/week for 12 sessions. Receives: Other: Kinesio taping; Other: Pelvic floor exercise training |
| Pelvic floor exercise training | Active comparator | They will be treated by conventional pelvic floor exercises; 30 minutes, 3 times/week for 12 sessions. Receives: Other: Pelvic floor exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic floor impact questionnaire- short form 7 (PFIQ-7)
It will be used to evaluate the efficacy of a particular therapy, and to compare bladder, bowel or vaginal symptoms severity for all females in both groups (A\&B) before and after treatment. All of the items use the following response scale: 0, Not at all; 1, somewhat; 2, moderately; 3, quite a bit PFIQ-7 Score, Obtain the mean value for all of the answered items within the corresponding scale (possible value 0- 3) and then multiply by (100/3) to obtain the scale score (range 0-100). The final score is the sum of the scores from the 3 scales together to obtain the summary score (range 0-300).
Measured: 4 weeks
King's Health Questionnaire (KHQ)
The KHQ is a validated instrument for measuring the quality of life of women with urinary incontinence. This questionnaire consists of two parts and 32 items. The first part (21 items) contains two single-item questions that address General Health Perception and Incontinence Impact and the following seven multi-item domains: Role, Physical, and Social Limitations, Limitations in Personal Relationship, Emotional Problems, Sleep and Energy Disturbances associated with SUI, and Severity Measures for UI. The second part has an 11-item Symptom Severity Scale (SSS) that assesses the presence and severity of urinary symptoms. While the entire SSS is scored from 0 (best) to 30 (worst), the minimum possible score is 0 (best health) and the maximum possible score is 100 (worst health) for all other KHQ domains.
Measured: 4 weeks
Secondary outcomes (1)
Assessment of pelvic floor muscle strength
The pelvic floor muscle strength will be assessed using a perineometer for all females in both groups (A\&B) before and after treatment. Each participant will be positioned relaxed in supine with flexed, slightly abducted legs, where each participant will be asked to insert the probe that will be covered by condom and be lubricated with hypoallergic gel into her vaginal cavity, where 0.5-1 centimeter of the probe sustained visible outside of her introitus. Then each participant will be asked to squeeze by a maximum voluntary contraction in three repetitions, each will be last by 3 seconds, with 3 seconds rest in-between, Then, a 2-minutes rest break will be taken, followed by visible contraction of transversus abdominis muscle, as long without pelvic tilting. And will take the median of the three measures.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 Jun 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 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Nagy Mamdouh, Cairo University
- Investigators
- Dalia M. Kamel, Prof., Study chair, Department of Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265896
- Sponsor's protocol ID
- P.T.REC/012/004948
- Status last verified
- Feb 2024
- First submitted
- 10 Feb 2024
- Last updated
- 20 Feb 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 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinesiotaping on Activation of Abdominal Muscles in Female Patients With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT06265896
- Acronym / sponsor ID
- P.T.REC/012/004948
- Conditions
- Stress Urinary Incontinence
- Keywords
- Kinesiotaping, Abdominal Muscles, Female Patients, Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 20 Feb 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.
This study will be conducted to evaluate the effect of kinesiotaping on activation of abdominopelvic cavity for management of stress urinary incontinence females' patients.
Detailed description
Stress urinary incontinence, the involuntary leakage of urine during exercise or certain movements, is a common pelvic floor disorder that can negatively impact quality of life. Urinary incontinence is associated with reduced physical, social, and mental well-being. While alternative exercise regimens have been proposed, It was concluded there is insufficient evidence they reduce leakage in women with stress urinary incontinence.
Kinesio taping is a rehabilitative technique that provides support and stability to muscles using elastic tape. Kinesio tape has no drugs/chemicals and allows normal skin function.
Limited studies have shown taping specific abdominal areas can stimulate skin-organ reflexes and improve pelvic organ function through interactions between the pelvis, pelvic floor muscles, and synergists. Therefore, could suggested that KT application on abdominopelvic cavity might be emerged as a conservative treatment option for urinary incontinence There were couple of previous research investigated the KT efficacy on treating bladder over activity with promising results of improvements. Till now, there is no previous study illustrating the effect of kinesio taping on abdominopelvic cavity in stress urinary incontinence females. So, this study will be the first one in this issue. Therefore, it will have valuable benefits in physical therapy field and scientific research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesio taping +Pelvic floor exercise training | Experimental | Other: Kinesio taping, Other: Pelvic floor exercise trainingThey will be treated by Elastic Kinesio-tape of (K-Active) brand which will be applied over abdomen, which will be changed every 3 days and this will be maintained along four weeks, plus conventional pelvic floor exercises; 30 minutes, 3 times/week for 12 sessions. |
| Pelvic floor exercise training | Active comparator | Other: Pelvic floor exercise trainingThey will be treated by conventional pelvic floor exercises; 30 minutes, 3 times/week for 12 sessions. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women suffering from mild to moderate stress urinary incontinence, clinically diagnosed by the gynecologist.
- Their ages will be ranged from 30-50 years old.
- Their body mass index (BMI) will be ranged from (20-25 kg/m2).
- They shouldn't have any musculoskeletal or neurological disorders.
Key exclusion criteria (8 listed)
- Current pregnancy.
- Malignant condition
- History of acute infection
- Neurological problem
- Mental problem to prevent evaluation and cooperation
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 |
|---|---|---|
| Kinesio tapingTape will be applied on rectus abdominis muscles using muscles facilitation technique from origin to insertion of muscle with a tension between 15-35%. Band will start on symphysis pubis with no tension and then women make stretch on the abdominal region by deep abdominal inspiration and will end at xiphoid process. Tape will be applied on the right and left external oblique muscles; the procedure will start without tension from bottom and of 6-12 ribs, then the hip will be placed in flexion and rotation to opposite direction and the tape will be attached to pubic bone with tension between 15-35%. Finally, the tape will be performed on the right and left internal oblique muscles; the procedure will start without tension from anterior superior iliac spine and then the hip will be placed in extension position and the tape will be attached to lower 4 ribs and linea alba with tension between 15-35%. | Other | Kinesio taping +Pelvic floor exercise training |
| Pelvic floor exercise trainingThe intervention will be applied by a trained physical therapist. First of all, each participant will be instructed to relax thighs, bottom and abdomen musculature, then squeeze pelvic floor muscles 'focus on tightening without flexing abdomen, thighs or buttocks- avoid holding breath' 10 repetitions, 3 to 5 times a day (morning, afternoon, and night). Rest for 4 seconds and then repeat each contraction. Build up pelvic floor musculatures strength until each participant be able to do 10 slow contractions each time, holding them for 10 seconds each with rests of 4 seconds in between. Then do not hold your breath or tighten your stomach, bottom or thigh muscles at the same time. Will instruct participants to try holding each squeeze for a few seconds. | Other | Kinesio taping +Pelvic floor exercise training, Pelvic floor exercise training |
Primary outcome
Pelvic floor impact questionnaire- short form 7 (PFIQ-7)
Time frame: 4 weeks
It will be used to evaluate the efficacy of a particular therapy, and to compare bladder, bowel or vaginal symptoms severity for all females in both groups (A\&B) before and after treatment. All of the items use the following response scale: 0, Not at all; 1, somewhat; 2, moderately; 3, quite a bit PFIQ-7 Score, Obtain the mean value for all of the answered items within the corresponding scale (possible value 0- 3) and then multiply by (100/3) to obtain the scale score (range 0-100). The final score is the sum of the scores from the 3 scales together to obtain the summary score (range 0-300).
King's Health Questionnaire (KHQ)
Time frame: 4 weeks
The KHQ is a validated instrument for measuring the quality of life of women with urinary incontinence. This questionnaire consists of two parts and 32 items. The first part (21 items) contains two single-item questions that address General Health Perception and Incontinence Impact and the following seven multi-item domains: Role, Physical, and Social Limitations, Limitations in Personal Relationship, Emotional Problems, Sleep and Energy Disturbances associated with SUI, and Severity Measures for UI. The second part has an 11-item Symptom Severity Scale (SSS) that assesses the presence and severity of urinary symptoms. While the entire SSS is scored from 0 (best) to 30 (worst), the minimum possible score is 0 (best health) and the maximum possible score is 100 (worst health) for all other KHQ domains.
1 secondary outcome
Assessment of pelvic floor muscle strength
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 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.
Dalia M. Kamel, Prof. study chair
Department of Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio taping and Pelvic floor exercise training in people with Stress Urinary Incontinence, run by Cairo 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 20 Feb 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 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mai N Mamdouh, M.Sc. student (01014924808, G01014924808@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic floor impact questionnaire- short form 7 (PFIQ-7) (time frame: 4 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 20 Feb 2024.