Stress Urinary IncontinenceNCT06242093
Effects of Kegel ex's With and Without WBV on PFM Strength, Incontinence Intensity, and QOL in Patients With SUI.
A study testing whole body vibrator and GROUP B Pelvic floor muscle training (PFMT) and conservative treatment. in people with Stress Urinary Incontinence, run by Riphah International University at 1 site in Pakistan.
Trial summary
Urinary incontinence, characterized by involuntary loss of urine (International Continence Society), is a serious social and health issue whose incidence is increasing. Urinary incontinence refers to a condition in which urine is inadvertently excreted from the bladder to the urethra, usually due to a disability or an… Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- whole body vibrator and GROUP B Pelvic floor muscle training (PFMT) and conservative treatment.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2023to 15 Apr 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 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with diagnosed stress urinary incontinence (SUI)
- Age: 25-50
- Married
- Normal vaginal delivery
Who cannot join
- Pelvic inflammatory disease
- Recent operation (C-section)
- Perineal tears
- Chronic constipation
- Pelvic or genital cancer
- Medical problems such as heart disease that limited activities and cardiac pacemaker
- Neuromuscular disorders
- Lack of independent mobility and exercise therapy or WBVT contraindications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Kegel Exercises With and Without Whole Body Vibration on Pelvic Floor Muscle Strength, Incontinence Intensity and Quality of Life in Patients With Stress Urinary Incontinence
Urinary incontinence, characterized by involuntary loss of urine (International Continence Society), is a serious social and health issue whose incidence is increasing. Urinary incontinence refers to a condition in which urine is inadvertently excreted from the bladder to the urethra, usually due to a disability or an incapacity to control the bladder and urethral sphincter. Urinary incontinence is a common complaint in women, which can have an important influence on the quality of her life. Its prevalence is between 10% and 40%, and the most common form is stress urinary incontinence. Age, body mass index, genetic factors, pregnancy and delivery, and a history of hysterectomy, smoking, race, constipation and menopause have been considered as its risk factors.
Read the detailed description
Urinary incontinence, characterized by involuntary loss of urine (International Continence Society), is a serious social and health issue whose incidence is increasing. Urinary incontinence refers to a condition in which urine is inadvertently excreted from the bladder to the urethra, usually due to a disability or an incapacity to control the bladder and urethral sphincter. Urinary incontinence is a common complaint in women, which can have an important influence on the quality of her life. Its prevalence is between 10% and 40%, and the most common form is stress urinary incontinence. Age, body mass index, genetic factors, pregnancy and delivery, and a history of hysterectomy, smoking, race, constipation and menopause have been considered as its risk factors.
A Randomized controlled trial will be conducted to determine the effects of Kegel exercises with and without whole body vibration on pelvic floor muscle strength, incontinence intensity and quality of life in patients with stress urinary incontinence. A sample size of 26 SUI women's will be taken, Data will be collected from the private clinical setups of Lahore by using IQOL, Urinary intensity questionnaire: Urinary Incontinence Questionnaires (King's Health Questionnaire (KHQ), Muscle strength: PERFECT scale and SF-36 Questionnaire. A written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups of equal members. One group undergoing WBVT and Conservative treatment and other group with Pelvic floor muscle training with conservative treatment. The interventions will be provided for 30 minutes for 3-4 D/Week for 4 months. All participants in both groups will be evaluated before and after the treatment programs. Total duration of study will be 8 months after the approval of synopsis. Data will be analyzed by using SPSS 26.
KEY WORDS: Pelvic floor muscle strength, Quality of life, Stress urinary incontinence, Whole body vibration.
- Conditions
- Stress Urinary Incontinence
- Being tested
- whole body vibrator, GROUP B Pelvic floor muscle training (PFMT) and conservative treatment.
- Keywords
- Pelvic floor, Quality of life, urinary incontinence, pelvic floor disorders
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole body vibratorDevice
- WBVT and Conservative treatment Group A will receive WBVT with conservative treatment. The treatment will be given with the frequency of 34 times/week for 25-30 minutes with the help of Galileo vibration platform
GROUP B Pelvic floor muscle training (PFMT) and conservative treatment.Other
Pelvic floor muscle training (PFMT) and conservative treatment.
Group B will receive (PFMT) with conservative treatment. The PMFT group will be educated to do each exercise in 3-4 set with 15-20 repetitions and a 60-second relax between each set.
Time: 3-4 Times/WEEK for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| GROUP A WBVT and Conservative treatment | Experimental | WBVT and Conservative treatment
* Group A will receive WBVT with conservative treatment. The treatment will be given with the frequency of 34 times/week for 25-30 minutes with the help of Galileo vibration platform.
* Time: 3-4 Times/WEEK for 8 weeks Receives: Device: whole body vibrator |
| GROUP B Pelvic floor muscle training (PFMT) and conservative treatment. | Active comparator | Pelvic floor muscle training (PFMT) and conservative treatment.
* Group B will receive (PFMT) with conservative treatment. The PMFT group will be educated to do each exercise in 3-4 set with 15-20 repetitions and a 60-second relax between each set.
* Time: 3-4 Times/WEEK for 8 weeks Receives: Other: GROUP B Pelvic floor muscle training (PFMT) and conservative treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incontinence quality of life (QOL) questionnaire
A disease-specific questionnaire that measures incontinence-related quality of life (QoL).Format: 22 items evaluating concerns related to incontinence, which can be divided into 3 sub-scales: i.e. 1.avoidance and limiting behavior, 2. psycho-social impact, 3.social embarrassment. Scoring: Items are scored on a 5-point response scale with values ranging from 1 (extremely) to 5 (not at all). Scores are then transformed to a scale score ranging from 0-100 points, with higher scores indicating higher QoL
Measured: 8 weeks
Urinary intensity questionnaire
urinary incontinence questionnaires (King's Health Questionnaire [KHQ]:To assess and to evaluate urinary function for patients at different levels of urinary function, related to urinary leakage problems, frequency problems, and related to retention problems. The King's Health Questionnaire (KHQ) was designed to evaluate the impact of urinary incontinence on the quality of life. (r= >0.60).
Measured: 8 weeks
SF-36
QoL was assessed by the validated Portuguese version of the self-reported MOS SF-36, which consists of eight subscales: (1) Physical Role Function, (2) Physical Functioning, (3) Bodily Pain, (4) General Health Perception, (5) Vitality, (6) Social Role Functioning, (7) Emotional Role functioning, and (8) Mental Health. A substantial body of research supports the reliability of the SF-36 measurements. Subscale scores range from 0 to 100, with a lower score indicating lower QoL for that subscale. SF-36 (Cronbach's alpha greater than 0.85, reliability coefficient greater than 0.75).
Measured: 8 weeks
WHOLE BODY VIBRATION PLATFORM
The Galileo is a platform with a sagittal axle on which a teeterboard is tilted up and down (5 mm) at a variable frequency of 5-30 Hz. This movement produces mechanical oscillations with an average cycle length of about 40 msec, which is the time required to induce a natural monosynaptic stretching reflex in the respective muscle via the muscle spindle during one up and down movement.
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 posted5 Feb 2024
- Study start15 Mar 2023
- Primary completion15 Mar 2024
- Study completion15 Apr 2024
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 Riphah International 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
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Faiza Taufiq, PPDPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242093
- Sponsor's protocol ID
- S22C14G92026
- Status last verified
- Apr 2024
- First submitted
- 28 Jan 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Kegel Exercises With and Without Whole Body Vibration on Pelvic Floor Muscle Strength, Incontinence Intensity and Quality of Life in Patients With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT06242093
- Acronym / sponsor ID
- S22C14G92026
- Conditions
- Stress Urinary Incontinence
- Keywords
- Pelvic floor, Quality of life, urinary incontinence, pelvic floor disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 5 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.
Urinary incontinence, characterized by involuntary loss of urine (International Continence Society), is a serious social and health issue whose incidence is increasing. Urinary incontinence refers to a condition in which urine is inadvertently excreted from the bladder to the urethra, usually due to a disability or an incapacity to control the bladder and urethral sphincter. Urinary incontinence is a common complaint in women, which can have an important influence on the quality of her life. Its prevalence is between 10% and 40%, and the most common form is stress urinary incontinence. Age, body mass index, genetic factors, pregnancy and delivery, and a history of hysterectomy, smoking, race, constipation and menopause have been considered as its risk factors.
Detailed description
Urinary incontinence, characterized by involuntary loss of urine (International Continence Society), is a serious social and health issue whose incidence is increasing. Urinary incontinence refers to a condition in which urine is inadvertently excreted from the bladder to the urethra, usually due to a disability or an incapacity to control the bladder and urethral sphincter. Urinary incontinence is a common complaint in women, which can have an important influence on the quality of her life. Its prevalence is between 10% and 40%, and the most common form is stress urinary incontinence. Age, body mass index, genetic factors, pregnancy and delivery, and a history of hysterectomy, smoking, race, constipation and menopause have been considered as its risk factors.
A Randomized controlled trial will be conducted to determine the effects of Kegel exercises with and without whole body vibration on pelvic floor muscle strength, incontinence intensity and quality of life in patients with stress urinary incontinence. A sample size of 26 SUI women's will be taken, Data will be collected from the private clinical setups of Lahore by using IQOL, Urinary intensity questionnaire: Urinary Incontinence Questionnaires (King's Health Questionnaire (KHQ), Muscle strength: PERFECT scale and SF-36 Questionnaire. A written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups of equal members. One group undergoing WBVT and Conservative treatment and other group with Pelvic floor muscle training with conservative treatment. The interventions will be provided for 30 minutes for 3-4 D/Week for 4 months. All participants in both groups will be evaluated before and after the treatment programs. Total duration of study will be 8 months after the approval of synopsis. Data will be analyzed by using SPSS 26.
KEY WORDS: Pelvic floor muscle strength, Quality of life, Stress urinary incontinence, Whole body vibration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP A WBVT and Conservative treatment | Experimental | Device: whole body vibratorWBVT and Conservative treatment * Group A will receive WBVT with conservative treatment. The treatment will be given with the frequency of 34 times/week for 25-30 minutes with the help of Galileo vibration platform. * Time: 3-4 Times/WEEK for 8 weeks |
| GROUP B Pelvic floor muscle training (PFMT) and conservative treatment. | Active comparator | Other: GROUP B Pelvic floor muscle training (PFMT) and conservative treatment.Pelvic floor muscle training (PFMT) and conservative treatment. * Group B will receive (PFMT) with conservative treatment. The PMFT group will be educated to do each exercise in 3-4 set with 15-20 repetitions and a 60-second relax between each set. * Time: 3-4 Times/WEEK for 8 weeks |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with diagnosed stress urinary incontinence (SUI)
- Age: 25-50
- Married
- Normal vaginal delivery
Key exclusion criteria (8 listed)
- Pelvic inflammatory disease
- Recent operation (C-section)
- Perineal tears
- Chronic constipation
- Pelvic or genital cancer
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 |
|---|---|---|
| whole body vibrator• WBVT and Conservative treatment Group A will receive WBVT with conservative treatment. The treatment will be given with the frequency of 34 times/week for 25-30 minutes with the help of Galileo vibration platform | Device | GROUP A WBVT and Conservative treatment |
| GROUP B Pelvic floor muscle training (PFMT) and conservative treatment.Pelvic floor muscle training (PFMT) and conservative treatment. Group B will receive (PFMT) with conservative treatment. The PMFT group will be educated to do each exercise in 3-4 set with 15-20 repetitions and a 60-second relax between each set. Time: 3-4 Times/WEEK for 8 weeks | Other | GROUP B Pelvic floor muscle training (PFMT) and conservative treatment. |
Primary outcome
The incontinence quality of life (QOL) questionnaire
Time frame: 8 weeks
A disease-specific questionnaire that measures incontinence-related quality of life (QoL).Format: 22 items evaluating concerns related to incontinence, which can be divided into 3 sub-scales: i.e. 1.avoidance and limiting behavior, 2. psycho-social impact, 3.social embarrassment. Scoring: Items are scored on a 5-point response scale with values ranging from 1 (extremely) to 5 (not at all). Scores are then transformed to a scale score ranging from 0-100 points, with higher scores indicating higher QoL
Urinary intensity questionnaire
Time frame: 8 weeks
urinary incontinence questionnaires (King's Health Questionnaire [KHQ]:To assess and to evaluate urinary function for patients at different levels of urinary function, related to urinary leakage problems, frequency problems, and related to retention problems. The King's Health Questionnaire (KHQ) was designed to evaluate the impact of urinary incontinence on the quality of life. (r= >0.60).
SF-36
Time frame: 8 weeks
QoL was assessed by the validated Portuguese version of the self-reported MOS SF-36, which consists of eight subscales: (1) Physical Role Function, (2) Physical Functioning, (3) Bodily Pain, (4) General Health Perception, (5) Vitality, (6) Social Role Functioning, (7) Emotional Role functioning, and (8) Mental Health. A substantial body of research supports the reliability of the SF-36 measurements. Subscale scores range from 0 to 100, with a lower score indicating lower QoL for that subscale. SF-36 (Cronbach's alpha greater than 0.85, reliability coefficient greater than 0.75).
WHOLE BODY VIBRATION PLATFORM
Time frame: 8 weeks
The Galileo is a platform with a sagittal axle on which a teeterboard is tilted up and down (5 mm) at a variable frequency of 5-30 Hz. This movement produces mechanical oscillations with an average cycle length of about 40 msec, which is the time required to induce a natural monosynaptic stretching reflex in the respective muscle via the muscle spindle during one up and down movement.
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 19 Apr 2024.
- 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.
Faiza Taufiq, PPDPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole body vibrator and GROUP B Pelvic floor muscle training (PFMT) and conservative treatment. in people with Stress Urinary Incontinence, run by Riphah International 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 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: finished, as of the sponsor's last update on 19 Apr 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?
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?
The incontinence quality of life (QOL) questionnaire (time frame: 8 weeks). The study lists 4 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 19 Apr 2024.