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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01794910
Acronym
PFMT
Enrollment
297
Registered
2013-02-20
Start date
2010-02-28
Completion date
2012-06-30
Last updated
2013-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Floor Muscle Weakness

Keywords

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

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.

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

Sponsors

Federal University of Maranhao
CollaboratorOTHER
University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 45 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Pelvic floor muscle strength by two methodsThe 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

MeasureTime frameDescription
Application of a questionnaireOne day after 15 sessions of pelvic floor muscle training.Verification of age,type of delivery, number of deliveries through a questionnaire

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026