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

Stress Urinary Incontinence Clinical Trial

Official title:

Effectiveness of Pelvic Floor Muscle and Abdominal Training in Women With Stress Urinary Incontinence: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03401983
• Other study ID #: Effectiveness of Pelvic Floor
• Status: Completed
• Phase: N/A
• First received: January 2, 2018
• Last updated: January 16, 2018
• Start date: September 1, 2016
• Est. completion date: March 31, 2017

Study information

• Verified date: January 2018
• Source: Trakya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Muscle Weakness
• Paresis
• Pelvic Floor Muscle Weakness
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Other:
• Pelvic Floor Muscle Training and Abdominal Training
Pelvic Floor Muscle Training + Abdominal Training program was used in the study. The follow-up measurements of the PFMT+AT group were obtained in the 0th, 4th, and 8th weeks.
• Pelvic Floor Muscle Training
Pelvic Floor Muscle Training program was used in the study. The follow-up measurements of the PFMT group were obtained in the 0th, 4th, and 8th weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Trakya University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline pelvic floor muscle strength at 8 weeks	Pelvic floor muscle strength was measured using a perineometry device	0th, 4th, and 8th weeks.
Secondary	Change from baseline UDI-6 score at 8 weeks	Urinary symptoms were measured using the Urinary Distress Inventory (UDI-6)	0th, 4th, and 8th weeks.
Secondary	Change from baseline IIQ-7 score at 8 weeks	Urinary symptoms were measured using the Incontinence Impact Questionnaire (IIQ-7),	0th, 4th, and 8th weeks