Laser Acupuncture and Pelvic Floor Training on Stress Urinary Incontinence Postmenopausal
Primary Purpose
Stress, Urinary, Incontinence
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laser acupuncture therapy and pelvic floor training
Sponsored by
About this trial
This is an interventional treatment trial for Stress focused on measuring laser acupuncture, pelvic floor training, Urinary incontinence, postmenopausal
Eligibility Criteria
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:
- neuromuscular disorders
- Lumbar disc prolapse
- Gynaecological disorders
- Pacemakers
- Tumors
- Dermatological conditions
- Patient who take anticoagulant agents.
Sites / Locations
- Faculty of physical therapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Acupuncture
Medical
Arm Description
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
Medical group B, consisting of 20 women will be maintained their ordinary medical treatment
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04959084
Brief Title
Laser Acupuncture and Pelvic Floor Training on Stress Urinary Incontinence Postmenopausal
Official Title
Effectiveness of Laser Acupuncture and Pelvic Floor Training on Stress Urinary Incontinence in Obese Postmenopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2021 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
April 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Urinary, Incontinence
Keywords
laser acupuncture, pelvic floor training, Urinary incontinence, postmenopausal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
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
Arm Title
Medical
Arm Type
No Intervention
Arm Description
Medical group B, consisting of 20 women will be maintained their ordinary medical treatment
Intervention Type
Other
Intervention Name(s)
Laser acupuncture therapy and pelvic floor training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the pelvic floor muscles strength
Description
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
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Postmenopausal women with mild to moderate stress urinary incontinence will be included in the study
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
neuromuscular disorders
Lumbar disc prolapse
Gynaecological disorders
Pacemakers
Tumors
Dermatological conditions
Patient who take anticoagulant agents.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heba Embaby, Ph.D.
Phone
00201003191889
Email
dr.hebaembaby@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heba Embaby, Ph.D.
Organizational Affiliation
Cairo University CU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of physical therapy
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Laser Acupuncture and Pelvic Floor Training on Stress Urinary Incontinence Postmenopausal
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