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

A Randomized Controlled Trial Comparing the Effect of Pelvic Floor Muscle Training on Improving Muscle Strength of Women After Vaginal or Cesarean Delivery

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Floor Muscle Weakness
• Intervention / Treatment: Other: Pelvic floor muscle therapy

• Study Type: Interventional
• Enrollment (Actual): 297
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Maranhao
    • Sao Luis, Maranhao, Brazil, 65025-240
      • Post Graduate Program of Maternal and Child Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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
No Intervention: Controll group; Women with vaginal or cesarean deliveries did not did not undergo muscle training

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Application of a questionnaire	Verification of age,type of delivery, number of deliveries through a questionnaire	One day after 15 sessions of pelvic floor muscle training.

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Federal University of Maranhao
• Investigators: Study Director: Maria Bethânia C Chein, phD, Federal University of Maranhão

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: February 7, 2013
• First Submitted That Met QC Criteria: February 19, 2013
• First Posted (Estimate): February 20, 2013

Study Record Updates

• Last Update Posted (Estimate): February 20, 2013
• Last Update Submitted That Met QC Criteria: February 19, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Pregnancy; cesarean section; physiotherapy; Muscle strength; Exercise therapy; Pelvic Floor; natural childbirth
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness
• Other Study ID Numbers: U1111-1136-5605