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

NCT06079528 | Completed DMC

• 1 other identifier: DMAEMohamed
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stress Urinary Incontinence; Postmenopausal Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessing the change in Urinary Incontinence symptoms

  at baseline and after 12 weeks of intervention

Study Arms (2)

Electromagnetic Stimulation combined with visceral manipulation

EXPERIMENTAL

Consisted of 25 postmenopausal women with SUI received PEMS therapy augmented by VMT maneuvers in addition to supervised PFMT.

Device: Electromagnetic device; Other: visceral manipulation therapy; Other: General advice; Other: pelvic floor muscle training

Electromagnetic Stimulation associated with general advice

ACTIVE COMPARATOR

Control group (B) performed the same PFMT associated with general advice with no medical treatment.

Other: General advice; Other: pelvic floor muscle training

Interventions

Electromagnetic device 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.

Electromagnetic Stimulation combined with visceral manipulation

visceral manipulation therapy OTHER

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

Electromagnetic Stimulation combined with visceral manipulation

General advice OTHER

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.

Electromagnetic Stimulation associated with general advice; Electromagnetic Stimulation combined with visceral manipulation

pelvic floor muscle training OTHER

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

Electromagnetic Stimulation associated with general advice; Electromagnetic Stimulation combined with visceral manipulation

Eligibility Criteria

• Age: 50 Years - 66 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Outpatient clinic faculty of physical therapy cairo university

Dokki, Egypt

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dina Mohamed

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 12, 2023
• Study Start: June 1, 2022
• Primary Completion: December 20, 2022
• Study Completion: January 30, 2023
• Last Updated: October 12, 2023

Record last verified: 2023-10

Locations

EG (1)