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- Klinische Studie NCT00740428
Pelvic Floor Exercises During Gestation in the Prevention of Urinary Incontinence and Pelvic Floor Muscle Dysfunction
4. Dezember 2009 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Voraussichtlich)
48
Phase
- Phase 2
- Phase 3
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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São Paulo
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Assis, São Paulo, Brasilien, 19810-000
- Assis Regional Hospital
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
20 Jahre bis 35 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Weiblich
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: G1
pregnants for the first time who will receive the physical therapy guide
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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.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
UI reduction
Zeitfenster: 12 months
|
12 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Pelvic floor muscle dysfunction reduction
Zeitfenster: 12 monhs
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12 monhs
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Adriano Dias, Dr., Botucatu Medical School
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. März 2008
Primärer Abschluss (Tatsächlich)
1. Dezember 2008
Studienabschluss (Tatsächlich)
1. Juli 2009
Studienanmeldedaten
Zuerst eingereicht
22. August 2008
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
22. August 2008
Zuerst gepostet (Schätzen)
25. August 2008
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
7. Dezember 2009
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
4. Dezember 2009
Zuletzt verifiziert
1. Dezember 2009
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- upeclin/HC/FMB-Unesp-10
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