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

NCT ID: NCT01948713

Last Updated: 2017-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-07
• Study Completion Date: 2015-01-08

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.

Detailed Description

the strength of the pelvic floor muscles will be evaluated with the aid of a perineometer

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1

Strengthening of pelvic floor muscles.

Group Type: EXPERIMENTAL

Strengthening of pelvic floor muscles.

Intervention Type: OTHER

Kegel exercises kinesiotherapy

Group 2

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

Group Type: EXPERIMENTAL

Strengthening of pelvic floor muscles.

Intervention Type: OTHER

Kegel exercises kinesiotherapy

Strengthening of hip muscles.

Intervention Type: OTHER

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

Interventions

Strengthening of pelvic floor muscles.

Kegel exercises kinesiotherapy

Intervention Type: OTHER

Strengthening of hip muscles.

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simone A. Marques, researcher

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

University of Sao Paulo General Hospital

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 39704322 (View on PubMed)

Other Identifiers

SimoneM

Identifier Type: -

Identifier Source: org_study_id