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

Pelvic Floor Muscle Weakness Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01794910
• Other study ID #: U1111-1136-5605
• Status: Completed
• Phase: N/A
• First received: February 7, 2013
• Last updated: February 19, 2013
• Start date: February 2010
• Est. completion date: June 2012

Study information

• Verified date: February 2013
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 297
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Weakness
• Paresis
• Pelvic Floor Muscle Weakness

Intervention

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

Locations

Country	Name	City	State
Brazil	Post Graduate Program of Maternal and Child Health	Sao Luis	Maranhao

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Federal University of Maranhao

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The strength of pelvic floor muscle by digital palpation and perineometry were evaluated one day after 15 sessions of pelvic floor muscle training.	No
Secondary	Application of a questionnaire	Verification of age,type of delivery, number of deliveries through a questionnaire	One day after 15 sessions of pelvic floor muscle training.	No