The Effect of Reflexology and Pelvic Floor Muscle Exercises (Kegel) on Urinary Incontinence in MS Patients

Multiple Sclerosis Clinical Trial

Official title:

The Effect of Reflexology and Pelvic Floor Muscle Exercises (Kegel) on Urinary Incontinence in MS Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05541965
• Other study ID #: Reflexology55
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: September 2022
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The research was carried out as experiment, control group, pretest-posttest model and single-blind. The population of the study consisted of MS patients who applied to OMU (Ondokuz Mayıs University) Neurology Service and Neurology Outpatient Clinic between March 2020 and February 2022. Fifteen patients who met the inclusion criteria were included in the study. Patients were divided into reflexology, pelvic floor muscle exercise and control groups. The control group was not intervened, only data collection tools were applied.

Description:

The research was carried out as experiment, control group, pretest-posttest model and single-blind. The population of the study consisted of MS patients who applied to OMU (Ondokuz Mayıs University) Neurology Service and Neurology Outpatient Clinic between March 2020 and February 2022. Fifteen patients who met the inclusion criteria were included in the study. Patients were divided into reflexology, pelvic floor muscle exercise and control groups. The control group was not intervened, only data collection tools were applied. reflexology intervention The reflexology application was carried out in a separate and quiet room, on a stretcher/bed where the patient could lie down, by adjusting the temperature so that they would not feel cold/sweaty. First, the feet were cleaned with a warm, damp cotton towel. Odorless, room temperature baby oil was used to provide lubricity during the reflexology application. The reflexology protocol was started with the right foot. First of all, rotation, vibration, etc. are applied to the ankle and ankle areas. relaxation techniques were applied for 2 minutes. Afterwards, reflexology massage was applied to the spinal cord, brain, pituitary areas, kidney, ureter and bladder areas with appropriate techniques. The session was concluded with solar plexus compression and relaxation maneuvers. The same protocol was applied in the left foot. Immediately after each reflexology session, the patient was allowed to drink 1 glass (200 ml) of water to accelerate the excretion of toxic products. Reflexology session was completed in 40 minutes for both feet. Foot reflexology was applied to the reflexology group twice a week (40 minutes for both feet) for a total of 4 weeks. Pelvic floor muscle exercise (Kegel) application In the Kegel exercise group, the patients were taught the Kegel exercise at the first interview, and it was provided to be done under the guidance of the researcher. Afterward, they were asked to apply at least three times a day for four weeks, and a reminder SMS was sent to the patients daily.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosed with MS at least 6 months ago,
• Having an EDSS of <5,

Exclusion Criteria:

• To have wound on foots, varicose veins, etc. history of fractures causing loss of function, nail fungus,
• pregnancy,
• presence of acute infection
• To using any diuretic or incontinence medication,
• To have a curettage or pregnancy history in the last 6 months

Related Conditions & MeSH terms

• Enuresis
• Multiple Sclerosis
• Reflexology
• Sclerosis
• Urinary Incontinence

Intervention

Other:
• Reflexology and kegel exercises
Reflexology is specific to a foot massage, and it can use different symptoms for patients. Kegel exercise is specific an activities and it can used for urinary incontinence

Locations

Country	Name	City	State
Turkey	Afitap ÖZDELIKARA	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Index of severity incontinence (ISI)	The total score is between 0-12. A score of "0" indicates that there is no incontinence. The scale score is then categorized into 4 different levels of incontinence severity: 1-2: mild, 3-6: moderate, 8-9: severe, 10-12: very serious.	4 weeks
Primary	nternational Consultation on Incontinence Questionnaire Short Form(ICIQ-SF)	The scores that can be obtained from the scale range from 0 to 21; A low score indicates that urinary incontinence has little effect on quality of life, while a high score indicates that it affects the quality of life very much.	4 weeks
Primary	Incontinence quality of life (IQOL)	The total score ranges from 0 to 100. High scores indicate better quality of life than low scores.	4 weeks