Pelvic Floor Exercises During Gestation in the Prevention of Urinary Incontinence and Pelvic Floor Muscle Dysfunction

This study has been completed.
Sponsor:
Collaborators:
São Paulo State Health Department
Assis Health Secretariat
Information provided by:
UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:
NCT00740428
First received: August 22, 2008
Last updated: December 4, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Pelvic Floor Abnormalities
Procedure: Pregnants for receive the physical therapy guide
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: The Effectiveness of Pelvic Floor Exercises During Gestation in the Prevention of Urinary Incontinence and Pelvic Floor Muscle Dysfunction.

Resource links provided by NLM:


Further study details as provided by UPECLIN HC FM Botucatu Unesp:

Primary Outcome Measures:
  • UI reduction [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pelvic floor muscle dysfunction reduction [ Time Frame: 12 monhs ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: March 2008
Study Completion Date: July 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: G1
pregnants for the first time who will receive the physical therapy guide
Procedure: Pregnants for receive the physical therapy guide
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 Name: Physical therapy guide

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.

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 58 consenting pregnant for the first time aged between 20 and 35 years, with no experience of urinary loss episodes before gestation will be assessed.

Exclusion Criteria:

  • Women who had more than one previous pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740428

Locations
Brazil
Assis Regional Hospital
Assis, São Paulo, Brazil, 19810-000
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
São Paulo State Health Department
Assis Health Secretariat
Investigators
Principal Investigator: Adriano Dias, Dr. Botucatu Medical School
  More Information

No publications provided

Responsible Party: Adriano Dias, Botucatu Medical School
ClinicalTrials.gov Identifier: NCT00740428     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-10
Study First Received: August 22, 2008
Last Updated: December 4, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by UPECLIN HC FM Botucatu Unesp:
Pelvic floor,
muscular dysfunction,
urinary incontinence

Additional relevant MeSH terms:
Congenital Abnormalities
Urinary Incontinence
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014