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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03401983
Other study ID # Effectiveness of Pelvic Floor
Secondary ID
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
Health authority
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

Study Design


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
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