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

NCT ID: NCT06079528

Last Updated: 2023-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-01-30

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.

Conditions

Stress Urinary Incontinence; Postmenopausal Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Electromagnetic device

Intervention Type: 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.

visceral manipulation therapy

Intervention Type: 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

General advice

Intervention Type: 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.

pelvic floor muscle training

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

General advice

Intervention Type: 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.

pelvic floor muscle training

Intervention Type: 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

Interventions

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.

Intervention Type: DEVICE

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

Intervention Type: 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.

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 66 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Dina Mahmoud ALeshmawy Mohamed

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dina Mohamed

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Outpatient clinic faculty of physical therapy cairo university

Dokki, , Egypt

Countries

Egypt

Other Identifiers

DMAEMohamed

Identifier Type: -

Identifier Source: org_study_id