CClinicalTrials.gg
Status unknownNCT04959084Updated Jul 13, 2021

Laser Acupuncture and Pelvic Floor Training on Stress Urinary Incontinence Postmenopausal

An interventional study of Laser acupuncture therapy and pelvic floor training in Stress, Urinary and Incontinence, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to female participants aged 50 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-07-13.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
50 Years to 65 Years
Sex
Female
01

Study 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. 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 .

02

Conditions studied

  • Stress
  • Urinary
  • Incontinence

Keywords

  • laser acupuncture
  • pelvic floor training
  • Urinary incontinence
  • postmenopausal
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's planned enrollment of 45 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • neuromuscular disorders
  • Lumbar disc prolapse
  • Gynaecological disorders
  • Pacemakers
  • Tumors
  • Dermatological conditions
  • Patient who take anticoagulant agents.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Acupuncture

    Acupuncture 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

    Other: Laser acupuncture therapy and pelvic floor training

  • No intervention
    Medical

    Medical group B, consisting of 20 women will be maintained their ordinary medical treatment

Interventions

  • OtherLaser acupuncture therapy and pelvic floor training

    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.

06

What researchers measure

Primary outcomes

  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

    Time frame: 4 weeks following the end of sessions

07

Study locations

1 site
  • Faculty of physical therapy
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04959084
Lead sponsor
Cairo University
Responsible party
Heba Mohamed Aly Embaby (Assistant professor for physical therapy, Cairo University) — Principal investigator
First posted
Jul 13, 2021
Start date
Aug 1, 2021 (estimated)
Primary completion
Dec 1, 2021 (estimated)
Completion
Apr 1, 2022 (estimated)
Last update
Jul 13, 2021

Study contacts

Heba Embaby, Ph.D.
Contact
dr.hebaembaby@yahoo.com
00201003191889
Heba Embaby, Ph.D.
principal investigator · Cairo University CU

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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