- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00740428
Pelvic Floor Exercises During Gestation in the Prevention of Urinary Incontinence and Pelvic Floor Muscle Dysfunction
4 dicembre 2009 aggiornato da: UPECLIN HC FM Botucatu Unesp
The Effectiveness of Pelvic Floor Exercises During Gestation in the Prevention of Urinary Incontinence and Pelvic Floor Muscle Dysfunction.
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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Anticipato)
48
Fase
- Fase 2
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
São Paulo
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Assis, São Paulo, Brasile, 19810-000
- Assis Regional Hospital
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 20 anni a 35 anni (Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Femmina
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: G1
pregnants for the first time who will 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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
UI reduction
Lasso di tempo: 12 months
|
12 months
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Pelvic floor muscle dysfunction reduction
Lasso di tempo: 12 monhs
|
12 monhs
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Adriano Dias, Dr., Botucatu Medical School
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.
- de Assis LC, Bernardes JM, Barbosa AM, Santini AC, Vianna LS, Dias A. [Effectiveness of an illustrated home exercise guide on promoting urinary continence during pregnancy: a pragmatic randomized clinical trial]. Rev Bras Ginecol Obstet. 2015 Oct;37(10):460-6. doi: 10.1590/SO100-720320150005361. Portuguese.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 marzo 2008
Completamento primario (Effettivo)
1 dicembre 2008
Completamento dello studio (Effettivo)
1 luglio 2009
Date di iscrizione allo studio
Primo inviato
22 agosto 2008
Primo inviato che soddisfa i criteri di controllo qualità
22 agosto 2008
Primo Inserito (Stima)
25 agosto 2008
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
7 dicembre 2009
Ultimo aggiornamento inviato che soddisfa i criteri QC
4 dicembre 2009
Ultimo verificato
1 dicembre 2009
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- upeclin/HC/FMB-Unesp-10
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .