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

Primary Purpose

Pelvic Floor Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pelvic floor muscle therapy
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Floor Muscle Weakness focused on measuring Pregnancy, Pelvic Floor, Muscle strength, Exercise therapy, natural childbirth, cesarean section, physiotherapy

Eligibility Criteria

35 Years - 45 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Post Graduate Program of Maternal and Child Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Plevic floor muscle therapy

Controll group

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 7, 2013
Last Updated
February 19, 2013
Sponsor
University of Sao Paulo
Collaborators
Federal University of Maranhao
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1. Study Identification

Unique Protocol Identification Number
NCT01794910
Brief Title
A Randomized Controlled Trial Comparing the Effect of Pelvic Floor Muscle Training
Acronym
PFMT
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 Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Federal University of Maranhao

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Muscle Weakness
Keywords
Pregnancy, Pelvic Floor, Muscle strength, Exercise therapy, natural childbirth, cesarean section, physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
297 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Plevic floor muscle therapy
Arm Type
Experimental
Arm 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.
Arm Title
Controll group
Arm Type
No Intervention
Arm Description
Women with vaginal or cesarean deliveries did not did not undergo muscle training
Intervention Type
Other
Intervention Name(s)
Pelvic floor muscle therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Pelvic floor muscle strength by two methods
Description
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 Outcome Measure Information:
Title
Application of a questionnaire
Description
Verification of age,type of delivery, number of deliveries through a questionnaire
Time Frame
One day after 15 sessions of pelvic floor muscle training.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Bethânia C Chein, phD
Organizational Affiliation
Federal University of Maranhao
Official's Role
Study Director
Facility Information:
Facility Name
Post Graduate Program of Maternal and Child Health
City
Sao Luis
State/Province
Maranhao
ZIP/Postal Code
65025-240
Country
Brazil

12. IPD Sharing Statement

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

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