Skip to content

Effect of Electromagnetic Stimulation Combined With Visceral Manipulation on Stress Urinary Incontinence In Postmenopausal Women

Effect of Electromagnetic Stimulation Combined With Visceral Manipulation on Stress Urinary Incontinence In Postmenopausal Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06079528
Enrollment
50
Registered
2023-10-12
Start date
2022-06-01
Completion date
2023-01-30
Last updated
2023-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Urinary Incontinence, Postmenopausal Disorder

Brief summary

To examine the effect of electromagnetic stimulation combined with visceral manipulation on stress urinary incontinence in postmenopausal women

Detailed description

According to the authors' knowledge, no prior studies that included MS with a VMT maneuvers to improve the success rates of stress urinary incontinence (SUI) treatment. Consequently, the purpose of this study was to assess the effect of electromagnetic field stimulation with VMT and PFMT in treatment of postmenopausal women with SUI.

Interventions

Health wave's generator (Manufactured with Simeds S.r.l. by Machiavelli, Italy, with serial number 11492.) with two separate emission channels and asynchronous operation was employed, along with 100 saved and storable programs that could be altered by the user (intensity, frequency and phase time). The different associated applicators are recognized automatically. Magnetic field strength up to 100 Gauss and output frequency from (1 - 100) Hertz are programmable.

for the pelvic reproductive organs and their related structures (ligaments and fasciae) was applied one session/week for 12 weeks. Each patient was was advised to evacuate her bladder before starting the treatment session, mobility and motility testing of pelvic organs, together with the assessment of fascial tension, was then performed, with detecting restrictions, treatment was applied according to Hebgen

were directed for both groups in term of the following: Perform pelvic floor exercises regularly ; avoid constipation and straining; treat the cause of any chronic cough and infection of urethra or bladder; stop smoking; maintain a healthy weight; drinking sufficient amounts of healthy fluids (water); decrease the caffeine intake; and decrease the amount of acidic and spicy foods.

OTHERpelvic floor muscle training

consisted of 24 sessions of 45-60 min each, twice a week, for 12 weeks. The PFMT was divided into four phases. Proprioceptive (3 weeks): where the woman has gained adequate perception of PFM and performed fast and slow contractions; Simple (3 week): performed with the objective of promoting control of fast and slow contractions associated with small functional exercises; Elaborated (3 week): where the exercise evolved into functional exercises of greater amplitude; and Power (3 week): where the maximum voluntary contraction of the pelvic floor was promoted during efforts. In all sessions, contractions were performed for slow and fast fibers

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 66 Years
Healthy volunteers
Yes

Inclusion criteria

Fifty postmenopausal women suffering from SUI with grades mild to moderate, were referred from……..Hospital after SUI diagnosis confirmation with urodynamics. They were selected from outpatient clinic of department of physical therapy for Women's Health of the faculty of Physical Therapy, Cairo university. The inclusion criteria included sedentary and medically stable postmenopausal women, with age range of 50 to 66 years old.

Exclusion criteria

resence of a urinary tract infection (UTI), other types of UI, previous incontinence and pelvic floor surgeries, metallic implant, contraindications for MS, cognitive alterations, collagen or muscle-related diseases, and neurological abnormalities were

Design outcomes

Primary

MeasureTime frameDescription
Assessing the change in vaginal pressureat baseline and after 12 weeks of interventionwas measured by Kegel perineometer (pneumatic pelvic muscle trainer XFT-0010) designed by Shenzhen XFT Electronics co., Ltd China.

Secondary

MeasureTime frameDescription
Assessing the change in Urinary Incontinence symptomsat baseline and after 12 weeks of interventionthrough the Urogenital Distress Inventory Questionnaire - Short Form (UDI-6. It is related to symptoms associated with lower urinary tract dysfunction especially SUI and it has 6 items: 1-urination frequency, 2-Leakage associated with feeling of urgency, 3-Leakage associated with activity, 4-Sneezing or Coughing little amounts of urine, 5-Emptying bladder with difficulty, and 6-Discomfort in the genital area or lower abdomen. Obtain the mean values of all the answered items then multiply by 25. Scores are turned to a possible range of 0-100. Higher scores mean more symptom distress. An A-grade recommendation was given to this scale by the International Consultation of Incontinence because of published data indicated that the scale is valid, reliable, and responsive to change following standard psychometric testing

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026