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

Sponsor
University of Sao Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT01794910
Collaborator
Federal University of Maranhao (Other)
297
1
2
28
10.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pelvic floor muscle therapy
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
297 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Trial Comparing the Effect of Pelvic Floor Muscle Training on Improving Muscle Strength of Women After Vaginal or Cesarean Delivery
Study Start Date :
Feb 1, 2010
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Jun 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Post Graduate Program of Maternal and Child Health Sao Luis Maranhao Brazil 65025-240

Sponsors and Collaborators

  • University of Sao Paulo
  • Federal University of Maranhao

Investigators

  • Study Director: Maria Bethânia C Chein, phD, Federal University of Maranhao

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
LUIZ GUSTAVO OLIVEIRA BRITO, Assistant Physician, Department of Gynecology and Obstetrics, Ribeirao Preto School of Medicine, Sao Paulo University, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01794910
Other Study ID Numbers:
  • U1111-1136-5605
First Posted:
Feb 20, 2013
Last Update Posted:
Feb 20, 2013
Last Verified:
Feb 1, 2013
Keywords provided by LUIZ GUSTAVO OLIVEIRA BRITO, Assistant Physician, Department of Gynecology and Obstetrics, Ribeirao Preto School of Medicine, Sao Paulo University, University of Sao Paulo
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 20, 2013