Study of the Efficacy of 4 Treatments for Fecal Incontinence in Community-dwelling Women
Study of the Efficacy of Treatment of Fecal Incontinence in Community-dwelling Women: Assessment of Individual Efficacy on Anorectal Physiology and Cortical Plasticity, Its Impact on Clinical Severity and on Quality of Life.
연구 개요
상세 설명
Fecal incontinence is a prevalent condition with a major impact on quality of life. Currently four treatments are being used in clinical practice: Kegel exercises (K), biofeedback (BF), electrostimulation (ES) and transcutaneous neuromodulation (NM). Results in the literature are discordant and lack methodological rigour making scientific evidence weak.
The aim of this study is to assess the efficacy of these four treatments on community-dwelling women and their impact on anorectal physiology, on clinical severity and on QoL.
This is a randomized control trial. Patient physiology was studied with anorectal manometry and endoanal ultrasonography; clinical severity was assessed with Cleveland and St. Mark's scales, and QoL with the Faecal Incontinence Quality of Life (FIQL) and the EuroQol's EQ5D questionnaires. Urinary incontinence (UI) was also evaluated by means of International Consultation on Incontinence (ICIQ) score. Patients were randomized and assigned to K (control), BF+K, ES+K or NM+K, given active treatment for a 3-month period, and then evaluated again with identical tests and parameters to identify changes.
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age higher than 18
- To be woman
- Have had incontinence episiodes at least from 6 month since the beginning of the study
- Have had incontinence episodes during the last month prior the beginning of the study
- The patient is able to understand the nature and impliations of the study and, therefore, to decide her participation.
Exclusion Criteria:
- Not meeting inclusion criteria
- Have very mild condition (Wexner <4)
- To be unable to perform / understand the treatments properly
- Being pregnant
- To have used treatmets for fecal incontinence within the last six months prior to the start of the study
- If, at reserarcher's criteria, the patient has not the proper conditions to perform and finish the treatments.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Kegel exercises
Pelvic floor exercises designed in the 1950s' by Arnold Kegel.
|
The aim is to compare how each treatment improves symptoms and quality of life and which physiologic mechanisms affects.
The basal treatment which other therapies are compared to is Kegel.
|
|
실험적: biofeedback
Biofeeback therapy to improve neuromuscular coordination and strengthen sphincter contractility.
|
The aim is to compare how each treatment improves symptoms and quality of life and which physiologic mechanisms affects.
The basal treatment which other therapies are compared to is Kegel.
|
|
실험적: electrostimulation
Administration of electric current with a specific device (stimulator) and through a vaginal prove, in order to improve pelvic floor contractility.
|
The aim is to compare how each treatment improves symptoms and quality of life and which physiologic mechanisms affects.
The basal treatment which other therapies are compared to is Kegel.
|
|
실험적: transcutaneous neuromodulation
Stimulation of tibial nerve with a specific electric current through a stimulator and surface electrodes
|
The aim is to compare how each treatment improves symptoms and quality of life and which physiologic mechanisms affects.
The basal treatment which other therapies are compared to is Kegel.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
clinical severity
기간: Changes of severity after 3 month-treatment
|
severity of the symptoms measured with Cleveland score
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Changes of severity after 3 month-treatment
|
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maximum anal resting pressure
기간: Changes maximum anal resting pressure after 3 month-treatment
|
pressure of the anal canal measured with mmHg
|
Changes maximum anal resting pressure after 3 month-treatment
|
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maximum squeeze pressure
기간: Changes maximum squeeze pressure after 3 month-treatment
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pressure on the anal canal when squeezing measured with mmHg
|
Changes maximum squeeze pressure after 3 month-treatment
|
|
rectal sensitivity
기간: changes in rectal balloon filling after 3 month-treatment
|
patient's rectal perception, measured with cm3 of distention of a rectal balloon
|
changes in rectal balloon filling after 3 month-treatment
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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