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

U

University of Sao Paulo

Status

Completed

Conditions

Pelvic Floor Muscle Weakness

Treatments

Other: Pelvic floor muscle therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01794910
U1111-1136-5605

Details and patient eligibility

About

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.

Enrollment

297 patients

Sex

Female

Ages

35 to 45 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

297 participants in 2 patient groups

Plevic floor muscle therapy
Experimental group
Description:
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.
Treatment:
Other: Pelvic floor muscle therapy
Controll group
No Intervention group
Description:
Women with vaginal or cesarean deliveries did not did not undergo muscle training

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems