Footstool in Alleviating Symptoms of Evacuation Disorder (FASED)
FASED: Footstool in Alleviating Symptoms of Evacuation Disorder
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Pelvic floor dysfunction is a very common problem. The prevalence of this problem is estimated to be about 16 per 100,000 person years. In one study, 52% of patients with delayed gastric emptying and symptoms of nausea and vomiting had an evacuation disorder. In this condition, there is either impaired relaxation of the pelvic floor muscles or weakness of the pelvic floor muscles. This combined usually with impaired ability to sense presence of and quantity of stool and gas in the rectum leads to difficulty evacuating stool and gas. Characteristically, these patients have difficulty emptying stool even when its soft and pasty. Some of them can only feel empty when their stools are watery. However, diarrhea comes with its inherent risks of accidental bowel leakage.
The management of pelvic floor disorders is primarily pelvic floor biofeedback therapy. The purpose is to correct the abnormal physiology to help improve emptying. Additional therapies include use of stimulant suppositories and enemas and use of foot stool. The premise behind use of a foot stool is that is helps relax the pelvic floor muscle. While there are several companies making footstools, there is surprisingly very sparse literature supporting their use.
The purpose of this research study is to investigate whether using a footstool could improve bowel symptoms in patients who experience symptoms of pelvic floor dysfunction. Participants who are eligible and enroll will complete a 2 week baseline bowel diary followed by an 8 week period during which they will be asked to use a footstool provided to them. They will be randomly assigned either to a 7 or a 9 inch footstool. During this period they will also complete surveys about their bowel symptoms.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Ohio
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Columbus, Ohio, Vereinigte Staaten, 43210
- Ohio State University Wexner Medical Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
Age 18 years or older Able to understand, read, and write English
Evidence of pelvic floor dysfunction based on at least one of the following:
Symptoms of excessive straining during bowel movements, feeling of incomplete evacuation, or need for digital evacuation of stool more than 25% of the time Abnormal anorectal manometry Abnormal balloon expulsion test Abnormal magnetic resonance imaging (MRI) defecography or barium defecography
Exclusion Criteria:
Any physical, mental, or emotional condition that, in the opinion of the Principal Investigator, may pose a safety concern or interfere with study participation Prior use of a toilet footstool for defecation Currently pregnant, based on self-reported pregnancy status during screening Active cancer Current opioid use
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: 7 Inch footstool
Participants in this group receive a 7 inch footstool
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Use of a toilet footstool during defecation for 8 weeks.
Participants in this group received a 7-inch footstool designed to elevate the feet and modify toileting posture to facilitate bowel evacuation.
The intervention was performed during routine bowel movements at home.
Andere Namen:
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Aktiver Komparator: 9 inch footstool
Participants in this group receive a 9 inch footstool
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Use of a toilet footstool during defecation for 8 weeks.
Participants in this arm received a 9-inch footstool designed to elevate the feet and modify toileting posture to facilitate bowel evacuation.
The intervention was performed during routine bowel movements at home.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Average Weekly Complete Spontaneous Bowel Movements (CSBMs)
Zeitfenster: 8 weeks
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The change in average weekly number of complete spontaneous bowel movements (CSBMs) from baseline to Week 8 will be compared between participants randomized to the 7-inch footstool and participants randomized to the 9-inch footstool.
A CSBM is defined as a spontaneous bowel movement associated with a self-reported sense of complete bowel evacuation, as recorded in the daily bowel diary.
Baseline values will be calculated from the 2-week pre-intervention period.
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8 weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in Irritable Bowel Syndrome Symptom Severity Score
Zeitfenster: 8 weeks
|
Change in symptom severity from baseline to Week 8 as measured by the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS).
The IBS-SSS is a patient-reported outcome measure ranging from 0 to 500 points, with higher scores indicating more severe IBS symptoms (worse outcome) and lower scores indicating improvement in symptom severity.
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8 weeks
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Subhankar CHAKRABORTY, MD, Ph.D., Ohio State University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 2022H0334
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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