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

NCT01794910 | Completed

• 1 other identifier: U1111-1136-5605
• Study Type: interventional
• Target: 297
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Muscle Weakness

Keywords

Pregnancy; Pelvic Floor; Muscle strength; Exercise therapy; natural childbirth; cesarean section; physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Application of a questionnaire

  One day after 15 sessions of pelvic floor muscle training.

Study Arms (2)

Plevic floor muscle therapy

EXPERIMENTAL

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

Controll group

NO INTERVENTION

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

Interventions

Pelvic floor muscle therapy 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

Plevic floor muscle therapy

Eligibility Criteria

• Age: 35 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Federal University of Maranhao: collaborator

Study Sites (1)

Post Graduate Program of Maternal and Child Health

São Luís, Maranhão, 65025-240, Brazil

Location

Study Officials

• Maria Bethânia C Chein, phD

  Federal University of Maranhao

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Physician, Department of Gynecology and Obstetrics, Ribeirao Preto School of Medicine, Sao Paulo University

Study Record Dates

• First Submitted: February 7, 2013
• First Posted: February 20, 2013
• Study Start: February 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 20, 2013

Record last verified: 2013-02

Locations

BR (1)