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

Not Applicable

Completed

• Conditions: Postmenopausal Disorder; Stress Urinary Incontinence
• Interventions: Device: Electromagnetic device; Other: visceral manipulation therapy; Other: General advice; Other: pelvic floor muscle training

• Registration Number: NCT06079528
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2022-06-01
• Primary Completion: 2022-12-20
• Study Completion: 2023-01-30
• Status Verified: 2023-10
• Study First Submitted: 2023-10-06
• Study First Submitted QC: 2023-10-06
• Last Update Submitted: 2023-10-06
• Study First Posted: 2023-10-12
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electromagnetic Stimulation combined with visceral manipulation	Electromagnetic device	Consisted of 25 postmenopausal women with SUI received PEMS therapy augmented by VMT maneuvers in addition to supervised PFMT.
Electromagnetic Stimulation combined with visceral manipulation	General advice	Consisted of 25 postmenopausal women with SUI received PEMS therapy augmented by VMT maneuvers in addition to supervised PFMT.
Electromagnetic Stimulation combined with visceral manipulation	pelvic floor muscle training	Consisted of 25 postmenopausal women with SUI received PEMS therapy augmented by VMT maneuvers in addition to supervised PFMT.
Electromagnetic Stimulation associated with general advice	General advice	Control group (B) performed the same PFMT associated with general advice with no medical treatment.
Electromagnetic Stimulation combined with visceral manipulation	visceral manipulation therapy	Consisted of 25 postmenopausal women with SUI received PEMS therapy augmented by VMT maneuvers in addition to supervised PFMT.
Electromagnetic Stimulation associated with general advice	pelvic floor muscle training	Control group (B) performed the same PFMT associated with general advice with no medical treatment.

Primary Outcome Measures

Name	Time	Method
Assessing the change in vaginal pressure	at baseline and after 12 weeks of intervention	was measured by Kegel perineometer (pneumatic pelvic muscle trainer XFT-0010) designed by Shenzhen XFT Electronics co., Ltd China.

Secondary Outcome Measures

Name	Time	Method
Assessing the change in Urinary Incontinence symptoms	at baseline and after 12 weeks of intervention	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

Trial Locations

Locations (1)

Outpatient clinic faculty of physical therapy cairo university; 🇪🇬 Dokki, Egypt