Effect of External Electrical Stimulation and Pelvic Floor Muscle Training

Not Applicable

Completed

• Conditions: Urinary Incontinence, Stress; Electrical Stimulation; Pelvic Floor Disorders; Urinary Incontinence
• Interventions: Behavioral: External electrical stimulation (EES) added to pelvic floor muscle training (PFMT); Behavioral: External electrical stimulation; Behavioral: Pelvic floor muscle training (PFMT)

• Registration Number: NCT04792125
• Lead Sponsor: Giresun University

Brief Summary

In this study, the effects of the external electrical stimulation (EES) added to pelvic floor muscle training (PFMT) on stress urinary incontinence (SUI) were investigated.

Detailed Description

Fifty one women with mild and moderate SUI symptoms were included in the study. The patients were divided into three groups of PFMT (n:17), EES (n:17) and PFMT+ EES (n:17) by block randomization. The PFMT was applied every day of the week, and EES was applied 3 days a week for 8 weeks. Pelvic floor muscle strength (PFMS), pelvic floor muscle endurance, subjective perception of improvement, severity of incontinence, quality of life, pelvic floor dysfunction (PTD) and urinary parameters were assessed as outcome variables. All measurements, except subjective perception of improvement were investigated before and after treatment.

Study Timeline

• Study Start: 2019-04-29
• Primary Completion: 2020-04-27
• Study Completion: 2020-04-27
• Study First Submitted: 2021-02-28
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-09
• Last Update Submitted: 2021-03-09
• Study First Posted: 2021-03-10
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 51

Inclusion Criteria

• having symptoms of pure stress urinary incontinence and stress predominant UI
• ability to contract pelvic floor muscle strength
• Having a mild or moderate SUI symptom according to the 24-hour pad test results.

Exclusion Criteria

• Pregnancy,
• Having been treated for incontinence within a period of six months ago,
• Not being able to cooperate,
• Presence of urinary infection
• Use of metal implants or cardiac pacemakers,
• Epilepsy,
• Presence of stage 3 or 4 pelvic organ prolapse,
• Presence of accompanying neurological disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
External electrical stimulation (EES) added to pelvic floor muscle training (PFMT) group	External electrical stimulation (EES) added to pelvic floor muscle training (PFMT)	This arm is going to include the patients who are performed external electrical stimulation (EES) added to pelvic floor muscle training (PFMT).
External electrical stimulation (EES) group	External electrical stimulation	This arm is going to include the patients who are performed external electrical stimulation (EES).
Pelvic floor muscle training (PFMT) group	Pelvic floor muscle training (PFMT)	This arm is going to include the patients who are performed pelvic floor muscle training (PFMT).

Primary Outcome Measures

Name	Time	Method
Self-reported improvement	8 weeks	Perception of urinary incontinence improvement compared with baseline was assessed using four-item Likert-type scale (worse, same, better, cured).

Secondary Outcome Measures

Name	Time	Method
24 hour pad test	8 weeks	Urinary incontinence severity was assessed.
pelvic floor muscle strength and endurance	8 weeks	measured using noninvasive vaginal perineometer

Trial Locations

Locations (1)

Giresun University; 🇹🇷 Giresun, Turkey