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Trial record 27 of 674 for:    (elderly OR senior) AND incontinence AND (woman OR women OR female)

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

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ClinicalTrials.gov Identifier: NCT03401983
Recruitment Status : Completed
First Posted : January 17, 2018
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Hatice Kahyaoglu Sut, Trakya University

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 Not Applicable

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.

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.


Study Type : Interventional  (Clinical Trial)
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 : September 1, 2016
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change from baseline pelvic floor muscle strength at 8 weeks [ Time Frame: 0th, 4th, and 8th weeks. ]
    Pelvic floor muscle strength was measured using a perineometry device


Secondary Outcome Measures :
  1. Change from baseline UDI-6 score at 8 weeks [ Time Frame: 0th, 4th, and 8th weeks. ]
    Urinary symptoms were measured using the Urinary Distress Inventory (UDI-6)

  2. Change from baseline IIQ-7 score at 8 weeks [ Time Frame: 0th, 4th, and 8th weeks ]
    Urinary symptoms were measured using the Incontinence Impact Questionnaire (IIQ-7),



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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
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

Responsible Party: Hatice Kahyaoglu Sut, Head of Department of Obstetrics and Gynecology Nursing, Trakya University
ClinicalTrials.gov Identifier: NCT03401983     History of Changes
Other Study ID Numbers: Effectiveness of Pelvic Floor
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Hatice Kahyaoglu Sut, Trakya University:
exercise
pelvic floor
stress urinary incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Enuresis
Muscle Weakness
Paresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes