Pelvic Floor Exercises During Gestation in the Prevention of Urinary Incontinence and Pelvic Floor Muscle Dysfunction
Condition: Pelvic Floor Abnormalities
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Urinary incontinence is any involuntary loss of urine. During gestation, hormonal and
      mechanical factors favor the incidence of urinary loss that may persist after delivery in up
      to 50% of women. Gestational urine loss can be prevented or treated during pregnancy with
      physical therapy. Pregnancy and delivery have been widely deemed important risk factors that
      should be assessed while developing preventive and curative treatments for both female
      urinary incontinence and pelvic floor muscle dysfunction. Pelvic floor muscle exercises, led
      by skilled physical therapists, can prevent, reduce, or even cure involuntary urine loss as
      well as pelvic floor muscle dysfunction. Within this framework, developing a low-cost,
      easy-to-perform method for the treatment of urinary incontinence and pelvic floor muscle
      dysfunction, with a preventive or curative approach, is considered necessary. The overall
      objective of this study is to assess the effects of pelvic floor exercises during pregnancy
      on pelvic floor muscles and urinary continence. Secondary aims include determining whether
      exercises change pelvic floor muscle function; if changing pelvic floor muscle function
      reduces the occurrence of urinary incontinence; developing and applying a manual guide; and
      determining whether the physical therapy guide is well accepted, easily understandable and
      reproducible.
    

Detailed description: 
      Urinary incontinence is any involuntary loss of urine. During gestation, hormonal and
      mechanical factors favor the incidence of urinary loss that may persist after delivery in up
      to 50% of women. Gestational urine loss can be prevented or treated during pregnancy with
      physical therapy. Pregnancy and delivery have been widely deemed important risk factors that
      should be assessed while developing preventive and curative treatments for both female
      urinary incontinence and pelvic floor muscle dysfunction. Pelvic floor muscle exercises, led
      by skilled physical therapists, can prevent, reduce, or even cure involuntary urine loss as
      well as pelvic floor muscle dysfunction. Within this framework, developing a low-cost,
      easy-to-perform method for the treatment of urinary incontinence and pelvic floor muscle
      dysfunction, with a preventive or curative approach, is considered necessary. The overall
      objective of this study is to assess the effects of pelvic floor exercises during pregnancy
      on pelvic floor muscles and urinary continence. Secondary aims include determining whether
      exercises change pelvic floor muscle function; if changing pelvic floor muscle function
      reduces the occurrence of urinary incontinence; developing and applying a manual guide; and
      determining whether the physical therapy guide is well accepted, easily understandable and
      reproducible. Thus, 58 consenting primipregnants aged between 20 and 35 years, with no
      experience of urinary loss episodes before gestation will be assessed. They will be allocated
      into 2 groups: G-I: pregnants for the first time who will receive the physical therapy guide,
      perform the exercises under the supervision of a physical therapist, and complete an exercise
      compliance form and a log with information on urinary losses; and G-II: pregnants for the
      first time who will just complete the urinary loss log without receiving the physical therapy
      guide and performing the exercises. Meetings with each participant will take place at 6
      occasions throughout pregnancy: at 18, 22, 26, 30, 34 and 38 weeks of gestation. At 18 weeks,
      all participants will be asked to respond to a baseline questionnaire with overall and
      specific gestational data. They will also be questioned about urine loss episodes over the
      past 30 days, and whether urine loss started during pregnancy. In addition, they will undergo
      pelvic floor evaluation by Pelvic Floor Functional Assessment (PFFA), and perineometry with a
      Portable PerinaStim perineometer. G-I women will be taught perineal contraction and receive
      an exercise guide for perineal contraction in 4 different positions. These women will be
      instructed to write down exercise frequency on a compliance form as well as the occurrence of
      urinary incontinence on a urinary loss log. In all 6 meetings, G-I and G-II participants will
      be reassessed by PFFA and perineometry, and asked to provide their completed urinary loss
      logs. G-I participants will also be requested to provide their completed exercise compliance
      form and once again perform the sequence of exercises included in the guide under the
      supervision of a physical therapist. During all meetings, the notes made on the exercise
      compliance form will be checked and later added to the baseline form of each participant. The
      performance of pelvic floor exercises during gestation is expected to have a positive effect
      on pelvic floor muscles and urinary continence. Pelvic floor muscle function is expected to
      improve reducing the occurrence of gestational urinary incontinence. In addition, the
      physical therapy guide is expected to be well accepted, understandable and reproducible. The
      results obtained in this study are intended to help clinical practice and open new research
      lines that may significantly contribute to women's health.
    

Intervention name(s): Pregnants for receive the physical therapy guide
Intervention type(s): Procedure
Intervention description(s): pregnants for the first time who will receive the physical therapy guide, perform the exercises under the supervision of a physical therapist, and complete an exercise compliance form and a log with information on urinary losses.
Other intervention name(s): Physical therapy guide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Pelvic floor,; muscular dysfunction,; urinary incontinence