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

Sponsor

Trakya University (Other)

Overall Status

Completed

CT.gov ID

NCT03401983

Collaborator

(none)

Enrollment

Arms

6.9

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence Pelvic Floor Muscle Weakness	Other: Pelvic Floor Muscle Training and Abdominal Training Other: Pelvic Floor Muscle Training	N/A

Detailed 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.

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Mar 31, 2017

Actual Study Completion Date :

Mar 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PFMT + AT Pelvic Floor Muscle Training and Abdominal Training	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.
Active Comparator: PFMT Pelvic Floor Muscle Training	Other: 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.

Arm

Intervention/Treatment

Experimental: PFMT + AT

Pelvic Floor Muscle Training and Abdominal Training

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.

Active Comparator: PFMT

Pelvic Floor Muscle Training

Other: 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.

Outcome Measures

Primary Outcome Measures

Change from baseline pelvic floor muscle strength at 8 weeks [0th, 4th, and 8th weeks.]
Pelvic floor muscle strength was measured using a perineometry device

Secondary Outcome Measures

Change from baseline UDI-6 score at 8 weeks [0th, 4th, and 8th weeks.]
Urinary symptoms were measured using the Urinary Distress Inventory (UDI-6)
Change from baseline IIQ-7 score at 8 weeks [0th, 4th, and 8th weeks]
Urinary symptoms were measured using the Incontinence Impact Questionnaire (IIQ-7),

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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