Stress Urinary IncontinenceNCT04590157
Neuromodulation Effect of Laser Acupuncture on Stress Urinary Incontinence
A study testing Low Level Laser Therapy and Pelvic floor muscle training in people with Stress Urinary Incontinence, run by Lama Saad El-Din Mahmoud at 1 site in Egypt.
Trial summary
background:Stress urinary incontinence (SUI) is the most common type of urinary incontinence in women, as it involves involuntary leakage of urine , the current study was To determine the neuromodulation effect of Laser Therapy on Neurogenic Acupoints in female with stress urinary incontinence (SUI). Read more about this study
- Who is it for?
- Ages 30 to 45 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Low Level Laser Therapy and Pelvic floor muscle training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2020to 30 Dec 2020
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age ranged from 30 to 45 years old
- body mass index (BMI) was less than 30 kg/m2,
- all women were non-smokers and they had a sedentary life style
Who cannot join
- The participants were excluded if they had other types of urinary incontinence (urge or mixed)
- urinary tract infection
- pelvic organ prolapse
- diabetes mellitus
- respiratory diseases, chronic cough and constipation
Trial locations and contacts
1 site in 1 country.
Doaa A Osman, PHD contact
Egypt1 site, 1 recruiting
- Recruiting
October 6 University
Giza, El-Sheikh Zayed City Giza 1133 Egypt
faculty of physical therapy October 6 University, 0238362496, pt@o6u.edu.eg
About this study
Official title: Neuromodulation Effect of Laser Acupuncture on Female Stress Urinary Incontinence: A Randomized Controlled Trial
background:Stress urinary incontinence (SUI) is the most common type of urinary incontinence in women, as it involves involuntary leakage of urine , the current study was To determine the neuromodulation effect of Laser Therapy on Neurogenic Acupoints in female with stress urinary incontinence (SUI).
Read the detailed description
Thirty women with SUI were randomly divided into two equal groups; the control group received pelvic floor muscle training , while the study group received the same pelvic floor muscle training in addition to laser acupuncture on neurogenic acupoints . The outcome measures were pelvic floor muscle strength (PFMS) , SUI severity assessed by Severity Index (SI) , and Incontinence Questionnaire-Short Form (ICIQ-SF). The outcome measures were assessed pre- and post-rehabilitation program.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Low Level Laser Therapy, Pelvic floor muscle training
- Keywords
- Neuromodulation, laser acupuncture, neurogenic acupoints, female 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.
Low Level Laser TherapyDevice
Laser Acupuncture application on Neurogenic Acupoints: the treatment based upon the use of low power laser light to stimulate acupuncture points
Pelvic floor muscle trainingOther
exercise prodram as follow: from supine lying position with legs slightly apart the patient asked to contract the pelvic muscles as hard as possible and hold for 10 seconds
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | received pelvic floor muscle training in addition to laser acupuncture on neurogenic acupoints Receives: Device: Low Level Laser Therapy; Other: Pelvic floor muscle training |
| control group | Experimental | received pelvic floor muscle training Receives: Other: Pelvic floor muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic floor muscle strength (PFMS)
The pelvic floor muscle strength of all women in both groups was assessed pre- and post-rehabilitation program, using XFT-0010 Pelvic Muscle Trainer device
Measured: 6 weeks
Stress urinary incontinence (SUI) severity
The incontinence severity index (ISI) consists of two questions, regarding frequency and amount of leakage. It categorizes urinary incontinence (UI) into slight, moderate, severe, and very severe.
Measured: 6 weeks
International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF).
it is a validated subjective measure used to assess the Stress urinary incontinence and its impact on quality of life
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start15 Oct 2020
- Primary completion15 Dec 2020 (estimated)
- Study completion30 Dec 2020 (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.
- 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
- the control group received pelvic floor muscle training ,and the study group received the same program in addition to laser acupuncture on neurogenic acupoints
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lama Saad El-Din Mahmoud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lama Saad El-Din Mahmoud, October 6 University
- Investigators
- Doaa A Osman, PHD, Principal investigator, lecturer, department of physical therapy for Women's Health faculty of physical therapy ,Cairo university,EgyptKhadiga S Abdulaziz, Study director, professor,department of physical therapy for Women's Health faculty of physical therapy ,Cairo university,egyptDoha R Ahmed, Bachelor, Principal investigator, Department of Physiotherapy, Ahmed Maher Teaching Hospital, Cairo, EgyptEmad E Atiya, PHD, Principal investigator, Professor, Department of Urology, Ahmed Maher Teaching Hospital, Cairo, EgyptLama S Mahmoud, PHD, Principal investigator, Lecturer, Department of Physical Therapy For Neuromuscular Disorders and its surgery, Faculty of Physical Therapy, October 6 University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590157
- Sponsor's protocol ID
- P.T. REC/012/002930
- Status last verified
- Oct 2020
- First submitted
- 9 Oct 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation Effect of Laser Acupuncture on Female Stress Urinary Incontinence: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04590157
- Acronym / sponsor ID
- P.T. REC/012/002930
- Conditions
- Stress Urinary Incontinence
- Keywords
- Neuromodulation, laser acupuncture, neurogenic acupoints, female stress urinary incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Lama Saad El-Din MahmoudUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 15 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 19 Oct 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:Stress urinary incontinence (SUI) is the most common type of urinary incontinence in women, as it involves involuntary leakage of urine , the current study was To determine the neuromodulation effect of Laser Therapy on Neurogenic Acupoints in female with stress urinary incontinence (SUI).
Detailed description
Thirty women with SUI were randomly divided into two equal groups; the control group received pelvic floor muscle training , while the study group received the same pelvic floor muscle training in addition to laser acupuncture on neurogenic acupoints . The outcome measures were pelvic floor muscle strength (PFMS) , SUI severity assessed by Severity Index (SI) , and Incontinence Questionnaire-Short Form (ICIQ-SF). The outcome measures were assessed pre- and post-rehabilitation program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- the control group received pelvic floor muscle training ,and the study group received the same program in addition to laser acupuncture on neurogenic acupoints
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Device: Low Level Laser Therapy, Other: Pelvic floor muscle trainingreceived pelvic floor muscle training in addition to laser acupuncture on neurogenic acupoints |
| control group | Experimental | Other: Pelvic floor muscle trainingreceived pelvic floor muscle training |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age ranged from 30 to 45 years old
- body mass index (BMI) was less than 30 kg/m2,
- all women were non-smokers and they had a sedentary life style
Key exclusion criteria (5 listed)
- The participants were excluded if they had other types of urinary incontinence (urge or mixed)
- urinary tract infection
- pelvic organ prolapse
- diabetes mellitus
- respiratory diseases, chronic cough and constipation
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 |
|---|---|---|
| Low Level Laser TherapyLaser Acupuncture application on Neurogenic Acupoints: the treatment based upon the use of low power laser light to stimulate acupuncture points | Device | study group |
| Pelvic floor muscle trainingexercise prodram as follow: from supine lying position with legs slightly apart the patient asked to contract the pelvic muscles as hard as possible and hold for 10 seconds | Other | control group, study group |
Primary outcome
Pelvic floor muscle strength (PFMS)
Time frame: 6 weeks
The pelvic floor muscle strength of all women in both groups was assessed pre- and post-rehabilitation program, using XFT-0010 Pelvic Muscle Trainer device
Stress urinary incontinence (SUI) severity
Time frame: 6 weeks
The incontinence severity index (ISI) consists of two questions, regarding frequency and amount of leakage. It categorizes urinary incontinence (UI) into slight, moderate, severe, and very severe.
International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF).
Time frame: 6 weeks
it is a validated subjective measure used to assess the Stress urinary incontinence and its impact on quality of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
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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.
Doaa A Osman, PHD contact
Doaa A Osman, PHD principal investigator
lecturer, department of physical therapy for Women's Health faculty of physical therapy ,Cairo university,Egypt
Khadiga S Abdulaziz study director
professor,department of physical therapy for Women's Health faculty of physical therapy ,Cairo university,egypt
Doha R Ahmed, Bachelor principal investigator
Department of Physiotherapy, Ahmed Maher Teaching Hospital, Cairo, 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 Low Level Laser Therapy and Pelvic floor muscle training in people with Stress Urinary Incontinence, run by Lama Saad El-Din Mahmoud 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 3 inclusion and 5 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 30 Oct 2020. 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 Lama S Mahmoud, PHD (01157592636, lamaelsedawyy@hormail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic floor muscle strength (PFMS) (time frame: 6 weeks). The study lists 3 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 30 Oct 2020.