Clinical trial NCT01705535: The Effect of Physiotherapy for the Treatment of Fecal Incontinence.
Official title: The Effect of Physiotherapy for the Treatment of Fecal Incontinence - a Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fecal Incontinence
Keywords: Fecal incontinence
Pelvic floor muscle exercises
Physiotherapy
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
First posted: 2012-10-12
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Prospective, investigator blinded, randomized controlled trial with two parallel arms. 100 participants will be randomized to one of two groups. Ratio 1:1. Baseline data consists of a physical examination, anal ultrasound and a thorough medical history including age, duration of complaints, fecal incontinence specific symptoms and known risk factors for fecal incontinence.

Group 1 will receive standard information and guidance and care by a specialized nurse. The treatment consists of advice about diet and fiber supplements and information about optimizing bowel emptying and use of antidiarrheal medication if appropriate. In addition the participants will receive six individual treatments of 30 minutes by a physiotherapist. This treatments will consist of massage of the back and neck. The participants will get no instructions on pelvic floor muscle exercises.

Group 2 will receive the same information and guidance by a specialist nurse as group 1. In addition they will receive six individual treatments of 45 minutes by a physiotherapist specialized in incontinence problems and pelvic floor disorders. The participants will get instructions in the anatomy and function of the pelvic floor muscles and instructions on how to do a correct pelvic floor muscle contraction. The pelvic floor muscle exercises will be taught both by verbal instructions and by vaginal and anal palpation. For each session by the physiotherapist, the participants will get a physiotherapeutic examination of the pelvic floor muscles by a vaginal and rectal examination. The pelvic floor muscle and the external anal sphincter strength will be measured according to the Modified Oxford Score (ranging 0-5). Endurance of sub-maximal contractions will be determined. The function of pelvic floor muscle will also be measured with intra-anal EMG biofeedback. Biofeedback will be used to give the participant visual and auditory feedback on a correct pelvic floor muscle contraction to enhance the participants awareness, strength and endurance of a correct pelvic floor muscle contraction. Biofeedback will also be used in sitting and standing position to assess the pelvic floor muscle function in those positions. According to the findings of the physiotherapeutic examinations there will be prepared an individual adapted pelvic floor muscle training program. The program consists of 3 sets of 10 contractions sustained up till 10 seconds and 2 sets of 3 contractions sustained up till 30 seconds. 1 minute rest between each set. The participants will also be instructed in how to contract the pelvic floor in response to anal urgency and in situations with increased intra abdominal pressure. The participants will be encouraged to perform the training program on a daily basis and will be instructed in filling out a training dairy. The diary will be used as a motivational tool and to quantify the amount of training. The individual training program will be adjusted, based on the findings from the examinations, and participants will be instructed to perform the exercises in different positions and during movements e.g. transfers, lifting, walking, coughing.

The treatments in both groups will be distributed over 16 weeks, with treatment in week 0,2,5,8,12 and 16.

Note 15. februar 2016:

Due to logistical reasons, we failed to perform the 12 months follow-up in the first 15 patients, which is why we decided to change the follow-up from 12 months to 36 months. This will enable us to perform a long-term outcome assessment for all included patients. This change does not affect the pre-specified primary endpoint.

In order to achieve as high respond rate as possible we decided to restrict the follow-up measurement to the questionnaires: Patient Global Impression of Improvement Scale (PGI-I scale), Fecal Incontinence Severity Index (FISI), St. Marks Incontinence Score (Vaizey) and Fecal Incontinence Quality of Life Scale (FIQL). Questions about further treatment for fecal incontinence since completion of the study and the amount of current pelvic floor muscle exercise will be added.

We thus decided to omit anal manometry, rectal capacity measurement and diaries from the 36 months follow-up measurements.

Eligibility 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

Primary outcomes:
measure: Patient Global Impression of Improvement Scale (PGI-I Scale)
timeFrame: Within 2 weeks after completion of intervention (16 weeks post baseline, primary analysis) Futher assessment: 12 month (follow-up).
Secondary outcomes:
measure: Fecal Incontinence Severity Index
timeFrame: Pre intervention start (baseline) and 16 weeks post baseline (primary analysis) Futher assessment: 12 month (follow-up).
measure: St. Marks Incontinence Score (Vaizey Score)
timeFrame: Pre intervention start (baseline) and 16 weeks post baseline (primary analysis) Futher assessment: 12 month (follow-up).
measure: Anal manometry
timeFrame: Pre intervention start (baseline) and 16 weeks post baseline (primary analysis) Futher assessment: 12 month (follow-up).
measure: Rectal capacity measurement
timeFrame: Pre intervention start (baseline) and 16 weeks post baseline (primary analysis) Futher assessment: 12 month (follow-up).
measure: Incontinence dairy
timeFrame: Pre intervention start (baseline) and 16 weeks post baseline (primary analysis) Futher assessment: 12 month (follow-up).
measure: Fecal Incontinence Quality of Life
timeFrame: Pre intervention start (baseline) and 16 weeks post baseline (primary analysis) Futher assessment: 12 month (follow-up).
Other outcomes:
measure: Training diary
timeFrame: During intervention and again at follow-up 1 year after completion of the intervention.
Locations:
city: Copenhagen
country: Denmark
facility: Department of Physiotherapy, Hvidovre University Hospital
Study officials:
affiliation: Hvidovre University Hospital Denmark, Department of Physiotherapy
name: Anja Ussing
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ussing A, Dahn I, Due U, Sorensen M, Petersen J, Bandholm T. Efficacy of Supervised Pelvic Floor Muscle Training and Biofeedback vs Attention-Control Treatment in Adults With Fecal Incontinence. Clin Gastroenterol Hepatol. 2019 Oct;17(11):2253-2261.e4. doi: 10.1016/j.cgh.2018.12.015. Epub 2018 Dec 20.