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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

297 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pelvic Floor Muscle Weakness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Plevic 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.

Group Type EXPERIMENTAL

Pelvic floor muscle therapy

Intervention Type OTHER

The women performed perineal contraction exercises in the dorsal decubitus, sitting, and standing positions and was applied twice per week for a total of 15 sessions

Controll group

Women with vaginal or cesarean deliveries did not did not undergo muscle training

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pelvic floor muscle therapy

The women performed perineal contraction exercises in the dorsal decubitus, sitting, and standing positions and was applied twice per week for a total of 15 sessions

Intervention Type OTHER

Eligibility Criteria

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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.

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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No