A Randomized Controlled Trial Comparing the Effect of Pelvic Floor Muscle Training

Not Applicable

Completed

• Conditions: Pelvic Floor Muscle Weakness
• Interventions: Other: Pelvic floor muscle therapy

• Registration Number: NCT01794910
• Lead Sponsor: University of Sao Paulo

Brief Summary

Aim: To determine the effects of pelvic floor muscle training (PFMT) in women with a single delivery route. Pregnancy and delivery route alter the pelvic floor muscle strength and are considered risk factors for urinary incontinence and genital dystopias. Methods: A Randomized controlled clinical trial with two hundred ninety-seven women aged 35 to 45 years old were selected for functional assessments of their pelvic floors by vaginal digital palpation and perineometry. One hundred sixty-five (69.7%) exhibited muscle strength deficits and were included in the clinical trial. The participants were distributed into two groups based on the delivery route (A, vaginal delivery and B, cesarean delivery) and were then randomly subdivided into Groups A1 (n = 44) and B1 (n = 42), who performed PFMT, and Groups A2 (n = 39) and B2 (n = 40), who did not undergo muscle training. The PFMT involved perineal contraction exercises in the dorsal decubitus, sitting, and standing positions and was applied twice per week for a total of 15 sessions. The functional assessment of pelvic floor by vaginal digital palpation and perineometry was performed after 15 sessions of pelvic´s floor muscles training. The statistical analysis was performed using the Mann-Whitney and Z tests at a 5% level of significance.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-02
• Study First Submitted: 2013-02-07
• Study First Submitted QC: 2013-02-19
• Last Update Submitted: 2013-02-19
• Study First Posted: 2013-02-20
• Last Update Posted: 2013-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 297

Inclusion Criteria

• age between 35 and 45 years old, obstetric antecedent of a single delivery route (i.e., vaginal or abdominal), and regular menstrual cycles for six months prior to the initial interview.

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Exclusion Criteria

• women who had complaints or clinical manifestations suggestive of urinary incontinence, intense pelvic or vaginal pain, past histories of physical therapy for pelvic floor strengthening, correction of genital prolapse, myomectomy, (total or subtotal) hysterectomy, morbidities such as diabetes and arterial hypertension, or body mass indices (BMIs) that were determined during the physical examination to be equal to or higher than 30 kg/m2.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plevic floor muscle therapy	Pelvic floor muscle therapy	The pelvic floor muscle therapy to women with vaginal or cesarean deliveries involved perineal contraction exercises in the dorsal decubitus, sitting, and standing positions and was applied twice per week for a total of 15 sessions.

Primary Outcome Measures

Name	Time	Method
Pelvic floor muscle strength by two methods	The strength of pelvic floor muscle by digital palpation and perineometry were evaluated one day after 15 sessions of pelvic floor muscle training.	Verification of pelvic floor muscle strength by digital palpation and perineometry before application of exercise and after 15 visits

Secondary Outcome Measures

Name	Time	Method
Application of a questionnaire	One day after 15 sessions of pelvic floor muscle training.	Verification of age,type of delivery, number of deliveries through a questionnaire

Trial Locations

Locations (1)

Post Graduate Program of Maternal and Child Health; 🇧🇷 Sao Luis, Maranhao, Brazil