Effect of Pelvic Floor and Hip Muscle Strengthening in the Treatment of Stress Urinary Incontinence

NCT01948713 | Completed

• 1 other identifier: SimoneM
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

INTRODUCTION: Stress urinary incontinence is a common condition in women and can be defined as the involuntary loss of urine on exertion, exercise, sneezing or coughing. This pathology causes physical discomfort and impacts the quality of life in a negative manner. Physiotherapeutic exercises is a treatment with low cost and high patient attendance. It can be applied with focus on strengthening the pelvic floor muscles or on muscular synergism. OBJECTIVE: To compare the effectiveness of Kegel exercises performed alone or performed in association with the strengthening of the muscles of the hip in the treatment of stress urinary incontinence. METHODOLOGY: The study is a randomized, blinded clinical trial. It aims at assessing objectively the strength of the pelvic floor, the improvement in the number of episodes of loss and impact on quality of life. The study will accept up to 40 women, who will be divided into two groups of physical therapy: group 1 (that will strengthen the pelvic floor muscles with Kegel exercises) and group 2 (that will perform strengthening the pelvic floor muscles with Kegel exercises associated with the strengthening of muscles of the hip). The two groups will be evaluated at the beginning and at the end of treatment.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Change in frequence of urinary incontinence

  number of episodes of urinary leakage per week

  At the first session of physical therapy and after 10 weeks of physical therapy treatment a voiding diary will be applied, and every session a follow up diary will be used. The physiotherapy treatment will be held twice a week for 10 weeks.

Secondary Outcomes (2)

• Change in strength of pelvic floor muscles

  At the first session of physical therapy and after 10 weeks of physical therapy treatment . The physiotherapy treatment will be held twice a week for 10 weeks.

• Change in quality of life

  At the first session of physical therapy and after 10 weeks of physical therapy treatment . The physiotherapy treatment will be held twice a week for 10 weeks.

Study Arms (2)

Group 1

EXPERIMENTAL

Strengthening of pelvic floor muscles.

Other: Strengthening of pelvic floor muscles.

Group 2

EXPERIMENTAL

Strengthening of pelvic floor muscles associated with strengthening of hip muscles.

Other: Strengthening of pelvic floor muscles.; Other: Strengthening of hip muscles.

Interventions

Strengthening of pelvic floor muscles. OTHER

Kegel exercises kinesiotherapy

Group 1; Group 2

Strengthening of hip muscles. OTHER

Kegel exercises and strengthening of hip muscles as Gluteus Maximus and Medius and adductor muscles

Group 2

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with 30 to 70 years of age;
• Clinical diagnosis of stress urinary incontinence;
• Urodynamic study.

You may not qualify if:

• Stress urinary incontinence with sphincter deficiency;
• Urinary urgence;
• Mixed urinary incontinence;
• Pregnant women;
• Neurological or muscular disease that interfere with continence;
• Urinary infection;
• Genital prolapse;
• Gynecological surgery for urinary incontinence in the last year;
• Hormone replacement therapy;
• Strength 0 in functional evaluation of the pelvic floor muscles.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of Sao Paulo General Hospital

São Paulo, São Paulo, 05403000, Brazil

Location

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

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

Study Officials

• Simone A. Marques, researcher

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: September 24, 2013
• Study Start: January 7, 2013
• Primary Completion: September 18, 2014
• Study Completion: January 8, 2015
• Last Updated: April 6, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)