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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06079528
• Other study ID #: DMAEMohamed
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: October 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 30, 2023
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 66 Years

Eligibility

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 exclusion criteria.

Related Conditions & MeSH terms

• Enuresis
• Postmenopausal Disorder
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Electromagnetic device
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.

Other:
• visceral manipulation therapy
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
• General advice
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.
• pelvic 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

Locations

Country	Name	City	State
Egypt	Outpatient clinic faculty of physical therapy cairo university	Dokki

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing the change in vaginal pressure	was measured by Kegel perineometer (pneumatic pelvic muscle trainer XFT-0010) designed by Shenzhen XFT Electronics co., Ltd China.	at baseline and after 12 weeks of intervention
Secondary	Assessing the change in Urinary Incontinence symptoms	through 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	at baseline and after 12 weeks of intervention