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Completed

NCT Number: NCT03401983

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pelvic Floor Muscle Training and Abdominal Training

Other

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

Other

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 outcomes

  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 outcomes

  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),

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 17, 2018
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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