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CompletedNCT01794910PFMTUpdated Feb 20, 2013

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

An interventional study of Pelvic floor muscle therapy in Pelvic Floor Muscle Weakness, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to female participants aged 35 Years to 45 Years. Per ClinicalTrials.gov, last updated 2013-02-20.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
297
Allocation
Randomized
Ages
35 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Pelvic Floor Muscle Weakness

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Keywords

  • Pregnancy
  • Pelvic Floor
  • Muscle strength
  • Exercise therapy
  • natural childbirth
  • cesarean section
  • physiotherapy
03

In context

Muscle Weakness

601 studies on the registry are indexed under Muscle Weakness; 99 are open to participants now.

This study's enrollment of 297 is above the median of 46 across 444 interventional studies indexed under Muscle Weakness.

Browse Muscle Weakness studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 45 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
297 participants (actual)

Study arms

  • 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

  • No intervention
    Controll group

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

Interventions

  • OtherPelvic 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

06

What researchers measure

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

    Time frame: 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

    Verification of age,type of delivery, number of deliveries through a questionnaire

    Time frame: One day after 15 sessions of pelvic floor muscle training.

07

Study locations

1 site
  • Post Graduate Program of Maternal and Child Health
    Sao Luis, Maranhao 65025-240, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01794910
Lead sponsor
University of Sao Paulo
Collaborators
Federal University of Maranhao
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) — Principal investigator
First posted
Feb 20, 2013
Start date
Feb 2010
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Feb 20, 2013

Study contacts

Maria Bethânia C Chein, phD
study director · Federal University of Maranhao

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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