Effectiveness of Pelvic Floor Muscle and Abdominal Training in Women With Stress Urinary Incontinence

Trakya University

Status: Completed

Conditions: Stress Urinary Incontinence; Pelvic Floor Muscle Weakness

Treatments: Other: Pelvic Floor Muscle Training; Other: Pelvic Floor Muscle Training and Abdominal Training

Study type: Interventional

Funder types: Other

Identifiers

NCT03401983

Effectiveness of Pelvic Floor

Details and patient eligibility

About

The aim of this study was to investigate the effectiveness of pelvic floor muscle and abdominal training in reproductive-age patients with stress urinary incontinence.

This prospective randomized controlled design study included 64 female patients aged 18-49 years with stress urinary incontinence. The patients were divided into 2 groups (32 PFMT "Pelvic Floor Muscle Training" and 32 PFMT+AT "Abdominal Training") by computer-based randomization. The stress urinary incontinence type was assessed by a stress test, and the pelvic floor muscle strength was measured with a home biofeedback device. Voiding functions were assessed by a 3-day voiding diary and uroflowmetric test. The UDI-6 scale was used to assess the urinary symptoms, and the IIQ-7 scale was used to assess the quality of life. The follow-up measurements of both groups were obtained in the 0th, 4th, and 8th weeks.

Full description

The aim of this study was to investigate the effectiveness of pelvic floor muscle and abdominal training in reproductive-age patients with stress urinary incontinence.

This prospective randomized controlled design study included 64 female patients aged 18-49 years with stress urinary incontinence. The patients were divided into 2 groups (32 PFMT "Pelvic Floor Muscle Training" and 32 PFMT+AT "Abdominal Training") by computer-based randomization. The stress urinary incontinence type was assessed by a stress test, and the pelvic floor muscle strength was measured with a home biofeedback device. Voiding functions were assessed by a 3-day voiding diary and uroflowmetric test. The UDI-6 scale was used to assess the urinary symptoms, and the IIQ-7 scale was used to assess the quality of life. The follow-up measurements of both groups were obtained in the 0th, 4th, and 8th weeks.

Participation of 29 patients from each group in the study was determined as sufficient to test the two-way hypothesis, with an effect size of 0.75, with an alpha level of 0.05, and with a power of 80%. However, 32 patients from each group were included as a precaution against possible missing data.

These women were randomly divided into the PFMT+AT (n=32) and PFMT (n=32) groups using a computer based randomization scheme. The data were collected from both groups at the 0th, 4th, and 8th weeks.

Enrollment: 64 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• 18-49 years
• Meet the diagnosis of simple female stress urinary incontinence (Degree 0 or 1)
• Volunteer to participate the study

Exclusion Criteria

• BMI ≥30
• Hysterectomy, urinary incontinence or pelvic floor operations
• Chronic health problem (cardiovascular, cerebral, diabetes, liver, kidney, psychiatric disease, etc.)
• Urge urinary incontinence, mixed urinary incontinence, overflow urinary incontinence
• SUI Degree ≥2
• Symptomatic urinary tract infection
• During pregnancy or lactation period

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

PFMT + AT

Experimental group

Description:

Pelvic Floor Muscle Training and Abdominal Training

Treatment:

Other: Pelvic Floor Muscle Training and Abdominal Training

PFMT

Active Comparator group

Description:

Pelvic Floor Muscle Training

Treatment:

Other: Pelvic Floor Muscle Training