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The Effect of Physiotherapy for the Treatment of Fecal Incontinence.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Anja Ussing, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier:
NCT01705535
First received: October 10, 2012
Last updated: August 19, 2016
Last verified: July 2016
  Purpose

Fecal incontinence is the complaint of involuntary loss of feces. Fecal incontinence affects 2-12% of the adult population. It is a hidden problem - less than one third of the affected persons discuss the problem with their doctor. The condition has a negative effect on quality of life. It is associated with shame and limitation in social life, leisure, occupational and sexual activities.

Pelvic floor muscle exercises with or without the use of biofeedback has been recommended and used for the treatment of fecal incontinence over the last decades. Several uncontrolled trials and some controlled trials have shown a positive effect of this training, but most of the trials are small and/or have methodological problems. Therefore there is to day still a lack of sufficient evidence for the effect of pelvic floor muscle exercise as a treatment of fecal incontinence.

The aim of this study is to compare the effect of an individual physiotherapeutic supervised pelvic floor muscle training program with a control physiotherapeutic treatment (massage of the neck and back). Both treatments will be given parallel with standard information and guidance given by a nurse specialized in anal incontinence issues.

Study hypothesis: Pelvic floor muscle exercises given parallel with standard advice and guidance by a specialized nurse, provides better effect to reducing fecal incontinence than control treatment and standard advice alone.


Condition Intervention
Fecal Incontinence
Behavioral: Individual supervised pelvic floor muscle exercises
Other: Massage of the neck and back
Behavioral: Standard information and guidance

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Physiotherapy for the Treatment of Fecal Incontinence - a Randomized, Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Copenhagen University Hospital, Hvidovre:

Primary Outcome Measures:
  • Patient Global Impression of Improvement Scale (PGI-I Scale) [ Time Frame: Within 2 weeks after completion of intervention (16 weeks post baseline, primary analysis) Futher assessment: 12 month (follow-up). ] [ Designated as safety issue: No ]
    Patients are asked to compare their incontinence symptoms before and after treatment and to rate changes on a seven point scale.


Secondary Outcome Measures:
  • Fecal Incontinence Severity Index [ Time Frame: Pre intervention start (baseline) and 16 weeks post baseline (primary analysis) Futher assessment: 12 month (follow-up). ] [ Designated as safety issue: No ]

    Change from baseline in Fecal Incontinence Severity Index (0-61 points) at 16 weeks.

    Severity score for fecal incontinence ranging from 0-61. 0=complete continence, 61=complete incontinence.


  • St. Marks Incontinence Score (Vaizey Score) [ Time Frame: Pre intervention start (baseline) and 16 weeks post baseline (primary analysis) Futher assessment: 12 month (follow-up). ] [ Designated as safety issue: No ]
    Change from baseline in St. Marks Incontinence Score (0-24 points) at 16 weeks. Score measuring fecal incontinence severity, ranging from 0-24. 0= complete continence, 24= complete incontinence.

  • Anal manometry [ Time Frame: Pre intervention start (baseline) and 16 weeks post baseline (primary analysis) Futher assessment: 12 month (follow-up). ] [ Designated as safety issue: No ]
    Changes from baseline in resting and squeeze pressure of the anal canal at 16 weeks

  • Rectal capacity measurement [ Time Frame: Pre intervention start (baseline) and 16 weeks post baseline (primary analysis) Futher assessment: 12 month (follow-up). ] [ Designated as safety issue: No ]
    Changes from baseline in sensory threshold, urge sensation, and maximum tolerable volume at 16 weeks.

  • Incontinence dairy [ Time Frame: Pre intervention start (baseline) and 16 weeks post baseline (primary analysis) Futher assessment: 12 month (follow-up). ] [ Designated as safety issue: No ]
    Changes from baseline in a incontinence dairy at 16 weeks. Participants are asked to fill out a two weeks incontinence dairy. The dairy gives insight into the defecation pattern, number of incontinence episode, presence of urge sensation, presence of urinary incontinence, presence of soiling, pad use and limitations in daily activities

  • Fecal Incontinence Quality of Life [ Time Frame: Pre intervention start (baseline) and 16 weeks post baseline (primary analysis) Futher assessment: 12 month (follow-up). ] [ Designated as safety issue: No ]
    Changes from baseline in Fecal Incontinence Quality of Life at 16 weeks. Fecal incontinence specific quality of life assessment. Consists of four subscales with 29 questions in total. The subscales are lifestyle, coping/behavior, depression/self-perception and embarrassment.


Other Outcome Measures:
  • Training diary [ Time Frame: During intervention and again at follow-up 1 year after completion of the intervention. ] [ Designated as safety issue: No ]
    Participants in the training group records the amount and duration of pelvic floor muscle exercises conducted each day during the intervention period and again over 1 week at follow-up


Enrollment: 102
Study Start Date: October 2012
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pelvic floor muscle exercises
Individual supervised pelvic floor muscle exercises. Standard information and guidance
Behavioral: Individual supervised pelvic floor muscle exercises
Six individual treatments of 45 minutes by a physiotherapist specialized in pelvic floor disorders. Preparation of an individual adapted training program for the pelvic floor muscles. Encouragement to perform the pelvic floor muscle training program on a daily basis
Other Names:
  • Pelvic floor muscle training
  • Physiotherapy
Behavioral: Standard information and guidance
Advice about diet and fiber supplements. Information about optimizing bowel emptying including use of medicine. Advice about use of antidiarrheal medication if appropriate.
Active Comparator: Masage of the neck and back
Massage of the neck and back. Standard information and guidance
Other: Massage of the neck and back
six individual treatments of 30 minutes by a physiotherapist. The participants will get no instructions of pelvic floor muscle exercises.
Behavioral: Standard information and guidance
Advice about diet and fiber supplements. Information about optimizing bowel emptying including use of medicine. Advice about use of antidiarrheal medication if appropriate.

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  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients refered to examination and treatment of fecal incontinence at the Department of surgical and medical Gastroenterology at Hvidovre University Hospital.
  • Duration of fecal incontinence for at least 6 month.

Exclusion Criteria:

  • Participants who has received more than 2 sessions of individual instructions of pelvic floor muscle exercises by a physiotherapist during the last 12 month.
  • Chronic diarrhea
  • Severe neurological disorders (multiple sclerosis, parkinsons, spinal cord injury,stroke or neuromuscular junction disease.
  • Rectal prolapse
  • Previously cancer operation or radiotherapy in the lower abdomen
  • Linguistically and/or cognitively incapable of understanding how to perform the pelvic floor muscle training program
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01705535

Locations
Denmark
Department of Physiotherapy, Hvidovre University Hospital
Copenhagen, Denmark, DK-2650 Hvidovre
Sponsors and Collaborators
Copenhagen University Hospital, Hvidovre
Investigators
Principal Investigator: Anja Ussing Hvidovre University Hospital Denmark, Department of Physiotherapy
  More Information

Responsible Party: Anja Ussing, Physiotherapist, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier: NCT01705535     History of Changes
Other Study ID Numbers: H-2-2012-067  H-2-2012-067 
Study First Received: October 10, 2012
Last Updated: August 19, 2016
Health Authority: Denmark: Ethics Committee

Keywords provided by Copenhagen University Hospital, Hvidovre:
Fecal incontinence
Pelvic floor muscle exercises
Physiotherapy

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 23, 2016