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Fecal Incontinence clinical trials

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NCT ID: NCT01274585 Terminated - Fecal Incontinence Clinical Trials

Does Percutaneous Tibial Nerve Stimulation (PTNS) Improve Outcomes in Patients Presenting With Fecal Incontinence

Start date: January 2011
Phase: N/A
Study type: Interventional

The primary objective of this study is to determine whether Percutaneous Tibial Nerve Stimulation (PTNS), a minimally invasive, simple, cost effective, and outpatient treatment of patients with urinary incontinence, can also be used to treat fecal incontinence. Specifically, the primary endpoint of this study is to determine, in a randomized controlled patient blinded study, whether PTNS decrease the episodes of fecal incontinence by 50% in the patients treated with PTNS when compared to placebo as documented by a 2 week patient bowel diary after treatment. The investigators secondary endpoints will consist of measurements of the impact of PTNS on the severity of incontinence (defined as a decrease in the mean Fecal Incontinence Severity Index (FISI) score ), as well as on the patient quality of life factors related to fecal incontinence (defined as a decrease in the mean Fecal Incontinence Quality of Life (FIQoL) scale).

NCT ID: NCT01011686 Terminated - Fecal Incontinence Clinical Trials

Safety Study of Autologous Cultured Adipose -Derived Stem Cells for the Fecal Incontinence

Start date: n/a
Phase: Phase 1
Study type: Interventional

Fecal incontinence affects 18.4% adults in the community and greatly impacts quality of life. There's a problem like inconvenience, pain or allergic response in many therapeutic methods such as a surgical operation or material injection. ANT-SM is autologous adipose-derived stem cell, and so, expect of no immune responses. In this study, patients are given injection of ANT-AM in anal sphincter and followed for 4 weeks to test the safety.

NCT ID: NCT00913601 Terminated - Fecal Incontinence Clinical Trials

Treatment of Faecal Incontinence With Sacral Nerve Stimulation - Improved Function With Stimulation Bilaterally?

SNS
Start date: May 2009
Phase: N/A
Study type: Interventional

Faecal incontinence is a devastating condition causing psychological stress, affecting daily living and influences quality of life. Faecal incontinence affects 2,2 to 5 % of the adult population. The magnitude of the problem is probably underestimated, because most patients don't discuss this affliction with their general practitioner. A new treatment, sacral nerve stimulation (SNS), has over the last decade given hope to these patients. The treatment is divided in two; first a test operation (PNE-test) has to reveal if the patient will benefit from treatment with permanent sacral nerve stimulation. Second if the patient benefit from the PNE-test, they proceed to final implant. 75-80% of the patients with idiopathic fecal incontinence benefit from the PNE-test, 70% of those get satisfactory functional results and the remaining 30% get suboptimal improvement in continence after permanent unilateral sacral nerve stimulation. The aim of this project is to investigate if bilateral sacral nerve stimulation can produce better fecal continence results than standard unilateral stimulation, through a double blind, randomized crossover study.

NCT ID: NCT00762047 Terminated - Fecal Incontinence Clinical Trials

A Prospective, Multi-center, Randomized, Blinded Study to Evaluate Durasphere FI for the Treatment of Fecal Incontinence

Start date: June 2004
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate a new injectable bulking agent for the treatment of fecal incontinence in adult men and women. This study has been designed to assess the safety, effectiveness and performance of Durasphere in adults suffering from fecal incontinence under monitored clinical conditions. The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score as the primary criteria by which success is evaluated.

NCT ID: NCT00556972 Terminated - Fecal Incontinence Clinical Trials

A Feasibility Study of a Fecal Incontinence Management System for Medical Use

Start date: January 2008
Phase: N/A
Study type: Interventional

The purpose of this feasibility study is to evaluate the performance and skin-friendliness of the barrier of the Fecal Incontinence Management System. The investigator will complete a questionnaire for each of the tested products and the products will be evaluated as regards leakage, wear time, and skin-friendliness.

NCT ID: NCT00387439 Terminated - Anal Incontinence Clinical Trials

ORALIA Trial Medical Treatment vs Anoperineal Physiotherapy for Adult Anal Incontinence.

Start date: October 2006
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the impact of anoperineal physiotherapy in adjunction to standard medical treatment on symptoms and quality of life of adults with anal incontinence, in comparison with standard treatment alone. A total of 443 patients will be randomized to 2 groups: standard care (medical treatment) alone or standard care associated with anoperineal physiotherapy. Outcome measures include the patient own view of the effectiveness of the treatment, the continence score, quality of life and psychological status. These outcomes are measured at the end of the 4 months treatment period. Following this period, the non responders to standard medical treatment will be proposed to undergo a course of anoperineal physiotherapy and the non responders to anoperineal physiotherapy will be treated by transcutaneous electrical nerve stimulation (TENS). The outcomes will be measured at the end of the 4 months new treatment and again after 4 months follow-up.

NCT ID: NCT00307775 Terminated - Fecal Incontinence Clinical Trials

Vaginal Estrogen for the Treatment of Faecal Incontinence in Women

Start date: March 2006
Phase: N/A
Study type: Interventional

This study will address the following questions: - Does the use of oestrogen inserted vaginally with an applicator, help with the symptoms of faecal (bowel) incontinence in women who are past the age of menopause? - Do women find it easy to use? - Is the treatment safe for the womb lining? - Is there any systemic absorption of the treatment?

NCT ID: NCT00292318 Terminated - Fecal Incontinence Clinical Trials

Treatment of Patients With Fecal Incontinence

Start date: January 2008
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if a behavioral treatment method called biofeedback will reduce the frequency of episodes of leakage of fecal material in patient suffering from fecal incontinence.

NCT ID: NCT00204763 Terminated - Fecal Incontinence Clinical Trials

Comparison of Esophageal and Anorectal Manometry Catheters

Start date: January 2004
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to compare the accuracy of esophageal and anorectal manometric pressure measurements using a newly developed air filled balloon catheter with present standard solid state esophageal and anorectal catheters, respectively.