Implantation of BioSphincter TM for Treatment of Severe Passive Fecal Incontinence
NCT ID: NCT05616208
Last Updated: 2025-04-09
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
PHASE1
Total Enrollment
10 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-11-02
Study Completion Date
2027-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This is first-in-human prospective Phase I study of the immediate and long-term safety of an implanted internal anal sphincter (IAS) bioengineered from autologous cells to treat subjects with severe passive FI who have failed standard treatments.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Trial to Evaluate Fecobionics in Fecal Incontinence (FI) (NORMAL and ABNORMAL-FI)
NCT05412069
Normal Subjects
Fecal Incontinence
RECRUITING
NA
Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence
NCT04976153
Fecal Incontinence
RECRUITING
PHASE3
Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence
NCT00200057
Fecal Incontinence
COMPLETED
NA
Autologous Muscle Fiber Fragment Injections
NCT05396456
Fecal Incontinence
RECRUITING
NA
Fat Grafting Technique for Fecal Incontinence
NCT03882632
Fecal Incontinence
UNKNOWN
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This is a two-center first-in-human prospective Phase I study of the immediate and long-term safety of an implanted internal anal sphincter (IAS) bioengineered from autologous cells to treat subjects with severe passive FI who have failed standard treatments. The data will be analyzed to assess the safety of the treatment and the potential initial efficacy of the implanted BioSphincter(TM) in decreasing the number of episodes of incontinence in subjects with severe FI.
After being informed of the risks, informed consent patients will undergo a biopsy procedure to collect tissue samples and will then undergo an implantation surgery of the bioengineered BioSphincter(TM). Patients will be followed for 36 months, post implantation.
After being informed of the risks, informed consent patients will undergo a biopsy procedure to collect tissue samples and will then undergo an implantation surgery of the bioengineered BioSphincter(TM). Patients will be followed for 36 months, post implantation.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Fecal Incontinence
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NA
Intervention Model
SINGLE_GROUP
This is a non-randomized, single group treatment study with a single arm and is not subject or investigator masked or blinded.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Implantation
This is a non-randomized, single group treatment study with a single arm and is not subject or investigator masked or blinded. BioSphincters will be implanted in every study subject.
Group Type
EXPERIMENTAL
Bioengineered Internal Anal Sphincter
Intervention Type
BIOLOGICAL
Autologous Bioengineered Internal Anal Sphincter
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bioengineered Internal Anal Sphincter
Autologous Bioengineered Internal Anal Sphincter
Intervention Type
BIOLOGICAL
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
BioSphincter(TM)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Patients are eligible to be included in the study only if all of the following criteria apply:
1. Males and females aged 18 years old and over at the time of signing the IRB approved informed consent.
2. Have the ability to understand the requirements of the study and are willing to comply with all study procedures.
3. In the opinion of the investigator, able to participate in the study.
4. Experience four or more FI episodes per 2-week period for the past 12 months. For purposes of this study, FI is defined as the loss of control sufficient to have stool in the subject's undergarments or require the changing of the undergarments. FI does not include the presence of a minimal amount of fecal material on the subject's undergarments and does not require the changing of the undergarments.
5. Failed standard medical and surgical therapies for FI as defined below:
1. Failure of standard medical therapy is defined as
* Bulking agents such as Citrucel or Metamucil fail to decrease the frequency of FI episodes to 4 or fewer episodes per two-week period after 4 weeks of treatment. Treatment failure is defined as a lack of response to the intervention after 4 weeks of treatment. Upon initiation of fiber, patients should see a change in stool consistency within 24-48 hours. Additional time for fiber treatment is needed to titrate the dose to optimize stool consistency and minimize side effects of bloating and increased flatus. Four weeks allows time to change stool consistency and measure changes in FI with a stable fiber regimen.
* Antidiarrheal agents such as Imodium or Lomotil may decrease FI or produce constipation but fail to decrease the frequency of FI episodes to 4 or fewer episodes per two-week period after 4 weeks of treatment. Treatment failure is defined as a lack of response to the intervention after 4 weeks of treatment. Upon initiation of Imodium or Lomotil, the patient should see a change in stool frequency within 24-48 hours. Additional time on Imodium/Lomotil treatment is needed to titrate the dose to optimize stool frequency and minimize side effects of bloating. Four weeks allows time to change stool frequency and measure changes in FI on a stable Imodium/Lomotil regimen.
* Failure of biofeedback training to reduce the frequency of FI episodes to 4 or fewer episodes per two-week period after 4 weeks of treatment. Treatment failure is defined as a lack of response to the intervention after 3 months of treatment. Three months of physical therapy is needed to allow strengthening of pelvic floor musculature and improvement in pelvic floor coordination.
2. Failure of standard surgical therapy is defined as
* Sacral nerve stimulation (SNS) fails to decrease the frequency of FI episodes to 4 or fewer episodes per two-week period after 2 months or more of treatment. SNS requires a two week period for two surgeries, trial implantation and then permanent implantation. During the two week period, patients can see a change in FI symptoms secondary to SNS implantation that informs the decision to proceed with permanent implantation. After permanent implantation, the settings of the SNS can be manipulated to optimize fecal control and minimize patient side effects. Two months allows time for the two surgeries to occur and SNS setting changes to ensure optimization of FI. Failure of SNS treatment will also include patients who have SNS explantation due to complications or side effects. Finally, SNS failure will also include patients who fail test stimulation and do not undergo chronic implantation. Patients can be considered to have SNS failure if after informed consent for the procedure, they elect to not undergo SNS trial or implantation.
* Sphincteroplasty failure will have occurred if the FI episode frequency is four or more episodes per two-week period, 12 months or more after surgical repair. After sphincteroplasty, patients may initially see an improvement in FI. However, over time, there has been a measured degradation in response to this surgical despite intact sphincter repair. Therefore, after 12 months, if a patient has undergone sphincteroplasty but fails to have improvement in FI, OR redevelops FI after initial improvement in FI, the patient will be eligible for potential trial enrollment.
3. Patients with severe passive fecal incontinence are eligible for the trial if they have failed all medical and surgical therapy for fecal incontinence and are being considered for a colostomy.
6. Anorectal manometry (ARM) testing history of ARM while at the discretion of the Physician/Surgeon. ARM must show low IAS pressure and presence of the Recto Anal Inhibitory Reflex (RAIR). Low IAS pressure is defined as ≤ 60 mmHg during the anorectal motility exam performed with a high-resolution catheter. Normal IAS pressure range is \> 60 mm Hg.
7. Pre-surgery, vital signs must be within the following parameters: SBP (mmHg) \>100 or \< 140; DBP (mmHg) \>60 or \<90; HR \>60 or \<100 bpm; afebrile, RR\< 20 or \>12 bpm; Pulse ox \>95% on room air.
8. Women of childbearing potential must use acceptable contraceptives during this study. Acceptable contraceptives include oral contraceptives and IUDs. Females of childbearing potential will have a urine pregnancy test on the day of trial enrollment.
9. Women not using hormonal contraception or hormonal replacement therapy (HRT) must have confirmation of a postmenopausal state. A high follicle stimulating hormone (\>40 IU/L) level in the postmenopausal range may be used; however, in the absence of 12 months of amenorrhea, confirmation with more than one FSH measurement is required.
10. Men of childbearing potential should use a medically accepted contraceptive during this study. Acceptable contraceptives include total abstinence and condoms + spermicide.
11. Colonoscopy performed within the past 5 years that excludes malignancy, inflammation, or infection.
12. Willingness to return for all follow-up visits through 36 months post-treatment.
1. Males and females aged 18 years old and over at the time of signing the IRB approved informed consent.
2. Have the ability to understand the requirements of the study and are willing to comply with all study procedures.
3. In the opinion of the investigator, able to participate in the study.
4. Experience four or more FI episodes per 2-week period for the past 12 months. For purposes of this study, FI is defined as the loss of control sufficient to have stool in the subject's undergarments or require the changing of the undergarments. FI does not include the presence of a minimal amount of fecal material on the subject's undergarments and does not require the changing of the undergarments.
5. Failed standard medical and surgical therapies for FI as defined below:
1. Failure of standard medical therapy is defined as
* Bulking agents such as Citrucel or Metamucil fail to decrease the frequency of FI episodes to 4 or fewer episodes per two-week period after 4 weeks of treatment. Treatment failure is defined as a lack of response to the intervention after 4 weeks of treatment. Upon initiation of fiber, patients should see a change in stool consistency within 24-48 hours. Additional time for fiber treatment is needed to titrate the dose to optimize stool consistency and minimize side effects of bloating and increased flatus. Four weeks allows time to change stool consistency and measure changes in FI with a stable fiber regimen.
* Antidiarrheal agents such as Imodium or Lomotil may decrease FI or produce constipation but fail to decrease the frequency of FI episodes to 4 or fewer episodes per two-week period after 4 weeks of treatment. Treatment failure is defined as a lack of response to the intervention after 4 weeks of treatment. Upon initiation of Imodium or Lomotil, the patient should see a change in stool frequency within 24-48 hours. Additional time on Imodium/Lomotil treatment is needed to titrate the dose to optimize stool frequency and minimize side effects of bloating. Four weeks allows time to change stool frequency and measure changes in FI on a stable Imodium/Lomotil regimen.
* Failure of biofeedback training to reduce the frequency of FI episodes to 4 or fewer episodes per two-week period after 4 weeks of treatment. Treatment failure is defined as a lack of response to the intervention after 3 months of treatment. Three months of physical therapy is needed to allow strengthening of pelvic floor musculature and improvement in pelvic floor coordination.
2. Failure of standard surgical therapy is defined as
* Sacral nerve stimulation (SNS) fails to decrease the frequency of FI episodes to 4 or fewer episodes per two-week period after 2 months or more of treatment. SNS requires a two week period for two surgeries, trial implantation and then permanent implantation. During the two week period, patients can see a change in FI symptoms secondary to SNS implantation that informs the decision to proceed with permanent implantation. After permanent implantation, the settings of the SNS can be manipulated to optimize fecal control and minimize patient side effects. Two months allows time for the two surgeries to occur and SNS setting changes to ensure optimization of FI. Failure of SNS treatment will also include patients who have SNS explantation due to complications or side effects. Finally, SNS failure will also include patients who fail test stimulation and do not undergo chronic implantation. Patients can be considered to have SNS failure if after informed consent for the procedure, they elect to not undergo SNS trial or implantation.
* Sphincteroplasty failure will have occurred if the FI episode frequency is four or more episodes per two-week period, 12 months or more after surgical repair. After sphincteroplasty, patients may initially see an improvement in FI. However, over time, there has been a measured degradation in response to this surgical despite intact sphincter repair. Therefore, after 12 months, if a patient has undergone sphincteroplasty but fails to have improvement in FI, OR redevelops FI after initial improvement in FI, the patient will be eligible for potential trial enrollment.
3. Patients with severe passive fecal incontinence are eligible for the trial if they have failed all medical and surgical therapy for fecal incontinence and are being considered for a colostomy.
6. Anorectal manometry (ARM) testing history of ARM while at the discretion of the Physician/Surgeon. ARM must show low IAS pressure and presence of the Recto Anal Inhibitory Reflex (RAIR). Low IAS pressure is defined as ≤ 60 mmHg during the anorectal motility exam performed with a high-resolution catheter. Normal IAS pressure range is \> 60 mm Hg.
7. Pre-surgery, vital signs must be within the following parameters: SBP (mmHg) \>100 or \< 140; DBP (mmHg) \>60 or \<90; HR \>60 or \<100 bpm; afebrile, RR\< 20 or \>12 bpm; Pulse ox \>95% on room air.
8. Women of childbearing potential must use acceptable contraceptives during this study. Acceptable contraceptives include oral contraceptives and IUDs. Females of childbearing potential will have a urine pregnancy test on the day of trial enrollment.
9. Women not using hormonal contraception or hormonal replacement therapy (HRT) must have confirmation of a postmenopausal state. A high follicle stimulating hormone (\>40 IU/L) level in the postmenopausal range may be used; however, in the absence of 12 months of amenorrhea, confirmation with more than one FSH measurement is required.
10. Men of childbearing potential should use a medically accepted contraceptive during this study. Acceptable contraceptives include total abstinence and condoms + spermicide.
11. Colonoscopy performed within the past 5 years that excludes malignancy, inflammation, or infection.
12. Willingness to return for all follow-up visits through 36 months post-treatment.
Exclusion Criteria
A patient is not eligible for inclusion in the study if any of the following criteria apply:
1. Symptomatic anorectal disease including hemorrhoid disease, anal fissure, or fistula causing symptoms such as bleeding, swelling, pain, or drainage.
2. Pre-existing anorectal pain of any cause.
3. Incontinence of flatus only.
4. Chronic watery diarrhea unmanaged by medical therapy and which is the primary cause for FI.
5. Greater than 60 degrees of either external anal sphincter disruption or both (\>60° IAS and EAS). Patients with severe (\>60 degree) disruption of the EAS ± IAS are likely to have a component of both urge (EAS) and passive (IAS) fecal incontinence. Due to a combined etiology of FI, patients with a large EAS ± IAS disruption are unlikely to have a significant improvement in FI from BioSphincter treatment.
6. Acute or chronic anorectal infections (including proctitis, recurrent abscesses, or fistulae).
7. Presence of anorectal tumors.
8. Active proctitis.
9. Uncontrolled inflammatory bowel disease (IBD) characterized by one or more of the following: CRP 10 mg/L, fecal calprotectin \> 200 mg/L, new or uncontrolled symptoms of IBD, endoscopic disease, evidence of inflammation on MR Imaging.
10. Any illness or disease requiring chemotherapy or any malignant disease within 5 years of enrollment.
11. History of organ transplantation requiring immunosuppressive medications.
12. History of a bleeding disorder diagnosed and treated by a hematologist, or patient with a diagnosed bleeding disorder currently being treated by a hematologist. If patient is on anticoagulation therapy which can be temporarily halted with permission from the prescribing provider for elective surgery, the patient will be eligible for the trial.
13. History of pelvic radiation, rectal prolapse, anorectal malformations, anorectal surgery within the previous 12 months or current colostomy..
14. Neurologic disease characterized by significant peripheral neuropathy or spinal cord dysfunction.
15. Mobility impairment requiring the use of assistive devices (e.g., wheelchair).
16. Current pregnancy, breastfeeding, or childbirth within previous 12 months.
17. History of unstable cardiac function (New York Heart Association Functional Classification III or IV).
18. History of unstable pulmonary function requiring home oxygen.
19. History of abnormal kidney function (Cr \>1.5 mg/dl or on dialysis).
20. Any clinically important abnormal laboratory tests, including but not limited to:
1. Hemoglobin \<10g.
2. ALT and AST \>2 times the upper limit of normal).
3. Bilirubin \>1.5mg/dl. For criteria a, b, and c, the test can be repeated one time at the discretion of the Investigator. If this option is used, the last obtained reading will be used for determination of eligibility. Averages will not be used.
21. Active untreated gynecological or urologic infection.
22. Documented history of or positive test results for human immunodeficiency virus (HIV)-1/HIV-2 Antibodies (Abs), Hepatitis B surface Antigen (HBsAg), or Hepatitis C Antibody (HCVAb) and evidence of a chronic active infection.
23. Presence of significant comorbidities that may be an underlying cause of FI (e.g., uncontrolled diabetes (\>7.5 HgA1C), severe spinal stenosis).
24. History of alcohol or substance abuse within past 12 months.
25. Concurrent participation in any other clinical investigation during the period of this investigation. Patients who have been treated with any other investigational drug or participated in any investigational study within 30 days prior to enrollment in this study.
26. Inability to participate in all necessary study activities due to physical or mental limitations.
27. Inability or unwillingness to return for all required follow-up visits.
28. Inability or unwillingness to sign informed consent.
29. Any circumstance in which the investigator deems that participation in the study is not in the subject's best interest.
30. Presence of increased surgical risk associated with jejunal or IAS biopsy (e.g., multiple previous surgeries with potential for adhesions, ventral hernia). Subjects also may be excluded during the biopsy procedure (i.e., an intraoperative exclusion) if the investigator observes any conditions that in the investigator's opinion would generate increased risk. Should this occur, biopsy will not be performed, and the subject will be classified as an intraoperative screen failure.
31. Previous history of anorectal surgery or disease which would prevent or increase the difficulty of surgical dissection of the intersphincteric space.
32. Allergy to Marcaine, epinephrine, betadine, Dermabond dressing, Prolene (polypropylene) suture, Polydioxanone suture (PDS) and Monocryl suture.
1. Symptomatic anorectal disease including hemorrhoid disease, anal fissure, or fistula causing symptoms such as bleeding, swelling, pain, or drainage.
2. Pre-existing anorectal pain of any cause.
3. Incontinence of flatus only.
4. Chronic watery diarrhea unmanaged by medical therapy and which is the primary cause for FI.
5. Greater than 60 degrees of either external anal sphincter disruption or both (\>60° IAS and EAS). Patients with severe (\>60 degree) disruption of the EAS ± IAS are likely to have a component of both urge (EAS) and passive (IAS) fecal incontinence. Due to a combined etiology of FI, patients with a large EAS ± IAS disruption are unlikely to have a significant improvement in FI from BioSphincter treatment.
6. Acute or chronic anorectal infections (including proctitis, recurrent abscesses, or fistulae).
7. Presence of anorectal tumors.
8. Active proctitis.
9. Uncontrolled inflammatory bowel disease (IBD) characterized by one or more of the following: CRP 10 mg/L, fecal calprotectin \> 200 mg/L, new or uncontrolled symptoms of IBD, endoscopic disease, evidence of inflammation on MR Imaging.
10. Any illness or disease requiring chemotherapy or any malignant disease within 5 years of enrollment.
11. History of organ transplantation requiring immunosuppressive medications.
12. History of a bleeding disorder diagnosed and treated by a hematologist, or patient with a diagnosed bleeding disorder currently being treated by a hematologist. If patient is on anticoagulation therapy which can be temporarily halted with permission from the prescribing provider for elective surgery, the patient will be eligible for the trial.
13. History of pelvic radiation, rectal prolapse, anorectal malformations, anorectal surgery within the previous 12 months or current colostomy..
14. Neurologic disease characterized by significant peripheral neuropathy or spinal cord dysfunction.
15. Mobility impairment requiring the use of assistive devices (e.g., wheelchair).
16. Current pregnancy, breastfeeding, or childbirth within previous 12 months.
17. History of unstable cardiac function (New York Heart Association Functional Classification III or IV).
18. History of unstable pulmonary function requiring home oxygen.
19. History of abnormal kidney function (Cr \>1.5 mg/dl or on dialysis).
20. Any clinically important abnormal laboratory tests, including but not limited to:
1. Hemoglobin \<10g.
2. ALT and AST \>2 times the upper limit of normal).
3. Bilirubin \>1.5mg/dl. For criteria a, b, and c, the test can be repeated one time at the discretion of the Investigator. If this option is used, the last obtained reading will be used for determination of eligibility. Averages will not be used.
21. Active untreated gynecological or urologic infection.
22. Documented history of or positive test results for human immunodeficiency virus (HIV)-1/HIV-2 Antibodies (Abs), Hepatitis B surface Antigen (HBsAg), or Hepatitis C Antibody (HCVAb) and evidence of a chronic active infection.
23. Presence of significant comorbidities that may be an underlying cause of FI (e.g., uncontrolled diabetes (\>7.5 HgA1C), severe spinal stenosis).
24. History of alcohol or substance abuse within past 12 months.
25. Concurrent participation in any other clinical investigation during the period of this investigation. Patients who have been treated with any other investigational drug or participated in any investigational study within 30 days prior to enrollment in this study.
26. Inability to participate in all necessary study activities due to physical or mental limitations.
27. Inability or unwillingness to return for all required follow-up visits.
28. Inability or unwillingness to sign informed consent.
29. Any circumstance in which the investigator deems that participation in the study is not in the subject's best interest.
30. Presence of increased surgical risk associated with jejunal or IAS biopsy (e.g., multiple previous surgeries with potential for adhesions, ventral hernia). Subjects also may be excluded during the biopsy procedure (i.e., an intraoperative exclusion) if the investigator observes any conditions that in the investigator's opinion would generate increased risk. Should this occur, biopsy will not be performed, and the subject will be classified as an intraoperative screen failure.
31. Previous history of anorectal surgery or disease which would prevent or increase the difficulty of surgical dissection of the intersphincteric space.
32. Allergy to Marcaine, epinephrine, betadine, Dermabond dressing, Prolene (polypropylene) suture, Polydioxanone suture (PDS) and Monocryl suture.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cellf Bio LLC
INDUSTRY
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jaime Bohl, MD
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Virginia Commonwealth University Health Main Hospital (VCU)
Richmond, Virginia, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
Baxter NN, Rothenberger DA, Lowry AC. Measuring fecal incontinence. Dis Colon Rectum. 2003 Dec;46(12):1591-605. doi: 10.1007/BF02660762.
Reference Type
BACKGROUND
Bharucha AE, Fletcher JG, Seide B, Riederer SJ, Zinsmeister AR. Phenotypic variation in functional disorders of defecation. Gastroenterology. 2005 May;128(5):1199-210. doi: 10.1053/j.gastro.2005.03.021.
Reference Type
BACKGROUND
Cleveland Clinic Incontinence Score. Vol. 0, 2021, p. 1993.
Reference Type
BACKGROUND
Engel AF, Kamm MA, Bartram CI, Nicholls RJ. Relationship of symptoms in faecal incontinence to specific sphincter abnormalities. Int J Colorectal Dis. 1995;10(3):152-5. doi: 10.1007/BF00298538.
Reference Type
BACKGROUND
Farouk R, Duthie GS, Pryde A, McGregor AB, Bartolo DC. Internal anal sphincter dysfunction in neurogenic faecal incontinence. Br J Surg. 1993 Feb;80(2):259-61. doi: 10.1002/bjs.1800800250.
Reference Type
BACKGROUND
Fecal Incontinence Quality of Life Scale (FIQOL). 2021.
Reference Type
BACKGROUND
Fecal Incontinence Severity Index ( FISI ). 2021.
Reference Type
BACKGROUND
Goode PS, Burgio KL, Halli AD, Jones RW, Richter HE, Redden DT, Baker PS, Allman RM. Prevalence and correlates of fecal incontinence in community-dwelling older adults. J Am Geriatr Soc. 2005 Apr;53(4):629-35. doi: 10.1111/j.1532-5415.2005.53211.x.
Reference Type
BACKGROUND
Huebner M, Margulies RU, Fenner DE, Ashton-Miller JA, Bitar KN, DeLancey JO. Age effects on internal anal sphincter thickness and diameter in nulliparous females. Dis Colon Rectum. 2007 Sep;50(9):1405-11. doi: 10.1007/s10350-006-0877-7.
Reference Type
BACKGROUND
Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307.
Reference Type
BACKGROUND
Luo C, Samaranayake CB, Plank LD, Bissett IP. Systematic review on the efficacy and safety of injectable bulking agents for passive faecal incontinence. Colorectal Dis. 2010 Apr;12(4):296-303. doi: 10.1111/j.1463-1318.2009.01828.x. Epub 2009 Mar 6.
Reference Type
BACKGROUND
Maeda Y, Laurberg S, Norton C. Perianal injectable bulking agents as treatment for faecal incontinence in adults. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD007959. doi: 10.1002/14651858.CD007959.pub3.
Reference Type
BACKGROUND
Norton C, Cody JD. Biofeedback and/or sphincter exercises for the treatment of faecal incontinence in adults. Cochrane Database Syst Rev. 2012 Jul 11;2012(7):CD002111. doi: 10.1002/14651858.CD002111.pub3.
Reference Type
BACKGROUND
Omar MI, Alexander CE. Drug treatment for faecal incontinence in adults. Cochrane Database Syst Rev. 2013 Jun 11;2013(6):CD002116. doi: 10.1002/14651858.CD002116.pub2.
Reference Type
BACKGROUND
Rao SS. Pathophysiology of adult fecal incontinence. Gastroenterology. 2004 Jan;126(1 Suppl 1):S14-22. doi: 10.1053/j.gastro.2003.10.013.
Reference Type
BACKGROUND
Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7. doi: 10.1007/BF02237236.
Reference Type
BACKGROUND
Sangwan YP, Coller JA, Schoetz DJ, Roberts PL, Murray JJ. Spectrum of abnormal rectoanal reflex patterns in patients with fecal incontinence. Dis Colon Rectum. 1996 Jan;39(1):59-65. doi: 10.1007/BF02048271.
Reference Type
BACKGROUND
Tan JJ, Chan M, Tjandra JJ. Evolving therapy for fecal incontinence. Dis Colon Rectum. 2007 Nov;50(11):1950-67. doi: 10.1007/s10350-007-9009-2.
Reference Type
BACKGROUND
Whitehead WE, Palsson OS, Simren M. Treating Fecal Incontinence: An Unmet Need in Primary Care Medicine. N C Med J. 2016 May-Jun;77(3):211-5. doi: 10.18043/ncm.77.3.211.
Reference Type
BACKGROUND
Zbar AP, Khaikin M. Should we care about the internal anal sphincter? Dis Colon Rectum. 2012 Jan;55(1):105-8. doi: 10.1097/DCR.0b013e318235b645.
Reference Type
BACKGROUND
Zutshi M, Tracey TH, Bast J, Halverson A, Na J. Ten-year outcome after anal sphincter repair for fecal incontinence. Dis Colon Rectum. 2009 Jun;52(6):1089-94. doi: 10.1007/DCR.0b013e3181a0a79c.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Fecal Microbial Transplantation for the Treatment of Fecal Incontinence in Women
NCT04201821
TERMINATED
PHASE1/PHASE2
Evaluation of the Efficacy and Safety of Autologous Fat Injection Into the Intersphincter Space in Fecal Incontinence: a Randomized, Placebo-controlled, Cross-over, Double-blind Trial
NCT04972799
RECRUITING
NA
A Feasibility Study of a Fecal Incontinence Management System for Medical Use
NCT00556972
TERMINATED
NA
Feasibility Study of the Magnetic Anal Sphincter (FENIX System)
NCT01625221
COMPLETED
NA
Effectiveness and Safety of Cell-Assisted Lipotransfer for the Treatment of Stress Urinary Incontinence
NCT01850342
UNKNOWN
PHASE1/PHASE2
Fecal Incontinence Treatment (FIT) Study
NCT03811821
ACTIVE_NOT_RECRUITING
NA
Safety, Efficacy and Quality of Life of Sphinkeeper Implantation for Fecal Incontinence
NCT06958497
COMPLETED
A Clinical Evaluation of a Vaginal Bowel Control System for the Treatment of Fecal Incontinence in Women (LIFE)
NCT01655498
COMPLETED
NA
Pelvipower for Faecal Incontinence
NCT05900726
UNKNOWN
NA
An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells as Therapy for Stress Urinary Incontinence
NCT00847535
COMPLETED
PHASE2
Autologous Myoblast Intrasphincteric Injection for Fecal Incontinence
NCT01523522
COMPLETED
PHASE2/PHASE3
Treatment of Anal Incontinence With Intersphincteric Implants
NCT03080753
TERMINATED
NA
Treatment of Faecal Incontinence With Sacral Nerve Stimulation - Improved Function With Stimulation Bilaterally?
NCT00913601
TERMINATED
NA
Cystic Fibrosis and Urinary Incontinence
NCT04922255
TERMINATED
NA
SphinkeeperTM Procedure for Treating Severe Faecal Incontinence
NCT04664868
COMPLETED
Peri-sphincter Injection of Autologous Myofibres to Treat of Urinary Incontinence by Sphincter Deficiency
NCT02606201
COMPLETED
NA
Sacral Neuromodulation and Faecal Incontinence and Its Unknown Effect on the External Anal Sphincter
NCT06763861
RECRUITING
Autologous Muscle Derived Cells for Underactive Bladder
NCT02463448
COMPLETED
PHASE1
Efficacy, Safety, and Performance Study of a Novel Device Designed to Manage Fecal Incontinence in Hospitalized Bedridden Patients With Liquid to Semi-formed Stool.
NCT02208258
WITHDRAWN
NA
Treatment of Fecal Incontinence by Injection of Autologous Muscle Fibers Into the Anal Sphincter
NCT01949922
UNKNOWN
NA
Muscle Progenitor Cell Therapy for Urinary Incontinence
NCT01953315
COMPLETED
PHASE1
Transdermal Administration by a Novel Wireless Iontophoresis Device
NCT06351852
COMPLETED
EARLY_PHASE1
Trial to Evaluate Fecobionics in Healthy Subjects and Patients
NCT04766138
COMPLETED
NA
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
NCT06738576
RECRUITING
PHASE1
Autologous Cell Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery
NCT02291432
COMPLETED
PHASE1/PHASE2