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

NCT03401983 | Completed

• 1 other identifier: Effectiveness of Pelvic Floor
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stress Urinary Incontinence; Pelvic Floor Muscle Weakness

Keywords

exercise; pelvic floor; stress urinary incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from baseline UDI-6 score at 8 weeks

  0th, 4th, and 8th weeks.

• Change from baseline IIQ-7 score at 8 weeks

  0th, 4th, and 8th weeks

Study Arms (2)

PFMT + AT

EXPERIMENTAL

Pelvic Floor Muscle Training and Abdominal Training

Other: Pelvic Floor Muscle Training and Abdominal Training

PFMT

ACTIVE COMPARATOR

Pelvic Floor Muscle Training

Other: Pelvic Floor Muscle Training

Interventions

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.

PFMT + AT

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.

PFMT

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years
• Meet the diagnosis of simple female stress urinary incontinence (Degree 0 or 1)
• Volunteer to participate the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Trakya University: lead

Related Publications (1)

• Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.

  PMID: 39704322 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress; Motor Activity

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Obstetrics and Gynecology Nursing

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 17, 2018
• Study Start: September 1, 2016
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: January 17, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share