Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00740428 |
| Other study ID # |
upeclin/HC/FMB-Unesp-10 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2/Phase 3
|
| First received |
August 22, 2008 |
| Last updated |
December 4, 2009 |
| Start date |
March 2008 |
| Est. completion date |
July 2009 |
Study information
| Verified date |
December 2009 |
| Source |
UPECLIN HC FM Botucatu Unesp |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Brazil: National Committee of Ethics in Research |
| Study type |
Interventional
|
Clinical Trial 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.
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.
