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

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

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence; Postmenopausal Disorder
• Intervention / Treatment: Device: Electromagnetic device; Other: visceral manipulation therapy; Other: General advice; Other: pelvic floor muscle training

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dokki, Egypt
    • Outpatient clinic faculty of physical therapy cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electromagnetic Stimulation combined with visceral manipulation; Consisted of 25 postmenopausal women with SUI received PEMS therapy augmented by VMT maneuvers in addition to supervised PFMT.	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; Other: 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.; Other: 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
Active Comparator: Electromagnetic Stimulation associated with general advice; Control group (B) performed the same PFMT associated with general advice with no medical treatment.	Other: 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.; Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Dina Mohamed, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: October 6, 2023
• First Submitted That Met QC Criteria: October 6, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: DMAEMohamed

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No