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StressNCT04959084

Laser Acupuncture and Pelvic Floor Training on Stress Urinary Incontinence Postmenopausal

A study testing Laser acupuncture therapy and pelvic floor training in people with Stress and Urinary, run by Cairo University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study will be directed to determine the effectiveness of laser acupuncture(LA) and pelvic floor training (PFT) on stress urinary incontinence (SUI) in obese postmenopausal women. Read more about this study

Who is it for?
Ages 50 to 65 years, women only
Conditions the study is for
Stress, Urinary, Incontinence
What is being tested?
Laser acupuncture therapy and pelvic floor training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteEgypt
Study dates
1 Aug 2021to 1 Apr 2022
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 50 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Forty obese postmenopausal women suffer from mild to moderate stress urinary incontinence
  • Their age ranges from 50-65 years old
  • The body mass index (BMI) ≥ 30 ≤ 40 Kg/m2.

Who cannot join

  • neuromuscular disorders
  • Lumbar disc prolapse
  • Gynaecological disorders
  • Pacemakers
  • Tumors
  • Dermatological conditions
  • Patient who take anticoagulant agents.

Trial locations and contacts

1 site in 1 country.

Heba Embaby, Ph.D. contact

00201003191889

dr.hebaembaby@yahoo.com

Egypt1 site
  • Faculty of physical therapy

    Cairo

Other trials in Egypt

About this study

Official title: Effectiveness of Laser Acupuncture and Pelvic Floor Training on Stress Urinary Incontinence in Obese Postmenopausal Women

This study will be directed to determine the effectiveness of laser acupuncture(LA) and pelvic floor training (PFT) on stress urinary incontinence (SUI) in obese postmenopausal women. Forty obese postmenopausal women will be selected , suffering from mild to moderate stress urinary incontinence from mild to moderate stress urinary incontinence, their age ranges from 50-65 years old and the body mass index (BMI) ≥ 30 ≤ 40 Kg/m2. then separate randomly into two equivalent gatherings. The study group (A) will receive laser acupuncture therapy and pelvic floor training for 30 min every other day for 12 sessions (3 times per week). While the control group (B) maintaining their ordinary medical treatment. All participants will be assessed the pelvic floor muscles strength by using Modified oxford grading scale and perineometer before starting intervention and at the end of the 12th session.

Read the detailed description

Menopause is the most significant period in a woman's life and brings in many physiological changes that affect life permanently. There have been a lot of opinions about the symptoms that appear before, during and after the onset of menopause . Menopause is associated with weight gain, as well as an increase in hypertension and diabetes. Estrogen deficiency can cause hormonal changes that contribute to the development of osteoporosis. Menopause is marked by hot flushes, sweating (especially at night), irritability, concentration issues, joint pain, vaginal dryness, and urogenital disorders( high rate of incontinence) .

Postmenopausal women are at danger for urogynecology dysfunction, incontinence, prolapse, and sexual dysfunction as circulating estrogen levels decrease with age. Their signs and symptoms may have a big impact on one's personal satisfaction. Menopause occurs at a normal age of 51 years in women, with the majority of women experiencing it between the ages of 45 and 55. As a result, women should expect to live for another 30 years after menopause .

SUI affects 20-30% of young women, 30-40% of moderately aged women, and up to half of the women in their later years, making it a major social issue that influences the greater part of postmenopausal women. This issue significantly influences the personal satisfaction of influenced women , also urinary incontinence may affect the functional ability of elderly females. Stress urinary incontinence is the most widespread type of incontinence (SUI). According to a study, SUI is often associated with conditions that cause high intra-abdominal pressure, for example, pregnancy with or without vaginal conveyance, obesity, and difficult physical work. The urogenital tract and pelvic floor contain estrogen and progesterone receptors. This may mean that these hormones play a role in continence. Estrogen does, in fact, increase urethral closure pressure, possibly due to increased blood flow. Estrogen has also been shown to improve the epithelia in the vagina, urethra, and bladder wall in postmenopausal women. As a result, it is reasonable to assume that using postmenopausal hormone therapy (HT) would reduce the risk of SUI .

The most well-known and potentially modifiable danger factor for the advancement of UI is obesity. In some studies, a positive connection between UI and body mass index (BMI) has effectively been created. Weight has a direct dose effect on incontinence, with every 5-unit expansion in BMI raising the risk of incontinence by 20 to 70%. And compared to ordinary-weight patients, obese patients have about double the risk of presenting with UI. Increased intra-abdominal pressure, as well as constant tension on tendons and nerves, can bother or cause pelvic floor problems by causing excessive stretching [6]. Increased intra-abdominal pressure (IAP) caused by obesity stresses the pelvic floor and leads to the growth of SUI, according to the prevailing unifying theory.

Changes in one's lifestyle can help with simple stress incontinence. Weight loss, liquid restriction, expected voiding, Kegel muscle preparation, and biofeedback are among the modifications. In addition, there is a group of incontinence schemes that can be used .The aim of timed voiding is to keep the bladder from being too full. Exercises to strengthen the pelvic floor muscles can aid elderly women with urinary incontinence .

Although there are many ways to treat urinary incontinence such as drug treatment and surgical intervention, but physical therapy is one of the most successful and best treatment methods used with patients with urinary incontinence, this method it is the best treatment methods that help patients strengthen the pelvic muscles and get rid of urinary incontinence .

Incontinence is often treated with pelvic floor exercise (Kegel's Exercise). It consists of repeated contractions of the pelvic floor muscles, especially the pubococcygeus muscle, to strengthen the muscles and improve micturition control . Pelvic floor exercise, including how to do a Kegel press, can be shown to the patient. When contracting the muscles used to avoid the outflow of urine or flatus, keep the stomach and thighs relaxed . In addition to laser treatment has a major role in the treatment of many cases .

Low-intensity laser therapy (LILT) is a type of phototherapy utilized as a therapy for many conditions, including musculoskeletal and delicate tissue wounds and persistent ulceration. Such lasers additionally prescribed as a successful choice to metal needles for the incitement of acupuncture or musculoskeletal trigger focus. This type of treatment is ordinarily named "Laser Acupuncture" to recognize it from the more extensive restorative utilization of such laser gadgets .

Laser acupuncture is essentially safer than needle acupuncture because of the non- intrusive nature of treatment (for example in instances of disease) and a more suitable technique for the incitement of difficult points as auricular acupuncture points or points around the perineum or privates (e.g., for sexual dysfunction) . The lumbosacral area of the body may be treated with laser acupuncture to mimic pelvic floor muscles. Laser acupuncture can stimulate the posterior S1 via BL31, S2 via BL32, S3 via BL33, S4 via BL34, and the pudendal nerve via BL35 at the lumbosacral area, as these techniques are effective in treating SUI. As a result, laser acupuncture can aid in the reinnervation and strengthening of pelvic floor muscles, thereby alleviating SUI symptoms .

Being tested
Laser acupuncture therapy and pelvic floor training
Keywords
laser acupuncture, pelvic floor training, Urinary incontinence, postmenopausal
Medical subject headings
Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laser acupuncture therapy and pelvic floor trainingOther

    The laser will be applied directly to the skin over acupuncture points and each point receive a shoot of 65 seconds followed by Pelvic floor exercises for 15 min.

Study groups in NCT04959084
Study groupRoleWhat they receive
AcupunctureExperimentalAcupuncture group A , consisting of 20 women will be received laser acupuncture therapy and pelvic floor training every other day for 30 min , 3 times per week for 12 sessions
Receives: Other: Laser acupuncture therapy and pelvic floor training
MedicalNo interventionMedical group B, consisting of 20 women will be maintained their ordinary medical treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the pelvic floor muscles strength

    Modified oxford grading scale (MOS) Via vaginal palpation, it was used to measure pelvic floor muscle strength. The strength of PFMS is graded on a scale of 0-5. subjective assessment

    Measured: 4 weeks following the end of sessions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2021
  2. Study start1 Aug 2021 (estimated)
  3. Primary completion1 Dec 2021 (estimated)
  4. Study completion1 Apr 2022 (estimated)

Resources

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
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04959084
Sponsor's protocol ID
LA and PFT in SUI
Status last verified
Jul 2021
First submitted
28 Jun 2021
Last updated
13 Jul 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Laser acupuncture therapy and pelvic floor training in people with Stress and Urinary, 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 3 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: status not confirmed, as of the sponsor's last update on 13 Jul 2021. 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 Heba Embaby, Ph.D. (00201003191889, dr.hebaembaby@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the pelvic floor muscles strength (time frame: 4 weeks following the end of sessions). 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 13 Jul 2021.

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