An interventional study of Pelvic floor rehabilitation in Fecal Incontinence, sponsored by Hospital de Mataró. Completed. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-09.
Sponsored by Hospital de Mataró · Not applicable, Interventional, and Treatment
This is a RCT aimed to assessing efficacy of kegel exercises,biofeedback, electrostimulation and transcutaneous neuromodulation on women with fecal incontinence, measuring its impact on anorectal physiology, cortical plasticity, clmical severity and the quality of life.
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.
283 studies on the registry are indexed under Fecal Incontinence; 52 are open to participants now.
This study's enrollment of 150 is above the median of 50 across 203 interventional studies indexed under Fecal Incontinence.
Browse Fecal Incontinence studies →Hospital de Mataró is the lead sponsor of 27 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Pelvic floor exercises designed in the 1950s' by Arnold Kegel.
Device: Pelvic floor rehabilitation
Biofeeback therapy to improve neuromuscular coordination and strengthen sphincter contractility.
Device: Pelvic floor rehabilitation
Administration of electric current with a specific device (stimulator) and through a vaginal prove, in order to improve pelvic floor contractility.
Device: Pelvic floor rehabilitation
Stimulation of tibial nerve with a specific electric current through a stimulator and surface electrodes
Device: Pelvic floor rehabilitation
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.
clinical severity
severity of the symptoms measured with Cleveland score
Time frame: Changes of severity after 3 month-treatment
maximum anal resting pressure
pressure of the anal canal measured with mmHg
Time frame: Changes maximum anal resting pressure after 3 month-treatment
maximum squeeze pressure
pressure on the anal canal when squeezing measured with mmHg
Time frame: Changes maximum squeeze pressure after 3 month-treatment
rectal sensitivity
patient's rectal perception, measured with cm3 of distention of a rectal balloon
Time frame: changes in rectal balloon filling after 3 month-treatment
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2013 to primary completion in Dec 2016, 46 months.
Of 70 non-industry interventional studies with no phase under Fecal Incontinence, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 57. This study's 46 months is above that.
Counting every sponsor, half of 86 studies reached it within 36 months; a quarter within 20 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital de Mataró