Urinary Incontinence, UrgeBAMANCT03543566
Bladder Antimuscarinic Medication and Accidental Bowel Leakage
An observational study of Urinary Incontinence, Urge and Fecal Incontinence, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This observational research study will examine whether a medication known as darifenacin (Enablex ®) used for urgency urinary incontinence (UUI) also helps to improve fecal incontinence symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Urge, Fecal Incontinence
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2018to 18 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients presenting to UAB urogynecology and continence clinics
Who may be able to join
- Women ≥18yrs presenting to UAB urogynecology and continence clinics with co-occurring UUI and FI
- Willing to complete all study related items
Who cannot join
- Severe constipation, fecal impaction or overflow fecal incontinence
- Inflammatory bowel disease, colorectal CA, spinal cord injury, multiple sclerosis, stroke, myasthenia gravis
- Infectious diarrhea
- Bothersome SUI (defined as "moderately" or greater bother on UDI-3)
- Patients planning to undergo surgery during study period
- Patients who are pregnant or intending to become pregnant during the study period
Show all 11Show fewer
- Patients with contraindications to antimuscarinic medications (ie. closed angle glaucoma)
- Patients on unstable or changing dosage of fiber or narcotics in the past 14 days
- Patients taking more than 2mg/day of loperamide (patients taking more than 2mg will be required a 2 week washout period)
- Patients currently taking medication for urgency urinary incontinence (these patients will also require a 2 week washout period)
- Patients initiating care with a pelvic floor physical therapist during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antimuscarinic Medication for Urgency Urinary Incontinence in Women With Dual Incontinence (Darifenacin for Treatment of Women With Dual Incontinence)
This observational research study will examine whether a medication known as darifenacin (Enablex ®) used for urgency urinary incontinence (UUI) also helps to improve fecal incontinence symptoms. Darifenacin is FDA approved for UUI, but is not FDA approved for fecal incontinence or specifically for dual incontinence (treatment of urinary incontinence and fecal incontinence at the same time). If participants are eligible for this study, they will have had symptoms of bothersome urgency urinary incontinence and fecal incontinence, and have decided to try medication for urgency urinary incontinence. Darifenacin (Enablex ®) is an oral medication which relaxes the bladder muscle to help prevent urgency urinary leakage. It is commonly used to treat overactive bladder and urgency urinary leakage. There is some evidence that this medication may also help with fecal incontinence by slowing the gut and preventing loose stools. Investigators are planning to enroll approximately 30 patients who have both UUI and fecal incontinence and who choose medical treatment as a part of their standard care.
Read the detailed description
Urgency urinary incontinence (UUI) and fecal incontinence (FI) are two highly prevalent pelvic floor disorders which negatively impact quality of life (QOL). Among women with urgency urinary incontinence (UUI), 8-20% also suffer from FI.
Initial management of both UUI and FI consists of behavioral therapies with or without pharmacologic management. First line management of FI includes diet, fluid and fiber intake adjustments (Grade A), antidiarrheal medication (Grade B) and exercises to strengthen and enhance awareness of the anal sphincter (Grade C). If symptoms fail to improve with these measures by 8-12 weeks, further investigations should be considered before moving to more invasive management options such as bulking agents, sphincterplasty or sacral nerve stimulation.
In addition to fiber and antidiarrheals, medications with antimuscarinic effects such as hyoscyamine and tricyclic antidepressants are often used in the treatment of FI and IBS-D. Antimuscarinic medications function in this setting by blockade of colonic muscarinic acetylcholine receptors causing smooth muscle relaxation, decreased gut motility and prolonged colon transit time.
In patients with overactive bladder (OAB) with UUI, anti-muscarinic medications or a β3-adrenoreceptor agonist medication can be added to behavioral therapy as first line to optimize symptom control and QOL (Gormley 2015). In patients being treated for UUI, constipation is often viewed as an unwanted side effect of antimuscarinic medications, with varying constipation rates observed among the different medications. Non-selective antimuscarinic medications such as fesoterodine (Toviaz ®) and tolterodine (Detrol ®) may be less likely to cause constipation, whereas newer M2 or M3-selective agents such as darifenacin (Enablex ®), solifencin (Vesicare®) or trospium (Sanctura ®) may be more constipating. Darifenacin is notable for the highest constipation rates- up to 15% for the 7.5mg dose, and up to 21% for the 15mg dose.
While there is no current evidence for one specific antimuscarinic medication use in patients suffering with dual incontinence (specifically UUI and FI), many providers use the more constipating antimuscarinic medications as treatment in this setting. Patients with loose-stool-predominant FI may benefit from the constipating side effects by slowed colonic transit time, firmer bowel movements and thereby improved bowel-related QOL. Only one study has previously examined the effect of antimuscarinic medication for OAB on bowel-related QOL. In this descriptive study, 90 patients who were treated with antimuscarinic medication for OAB were followed to measure change in ePAQ (electronic Personal Assessment Questionnaire) score. Investigators reported significant improvement in bowel-related QOL three to six months after treatment. Authors did not specify pre-treatment diagnoses, symptoms or details of the antimuscarinic treatment.
While anecdotally antimuscarinic medications are an effective first line medication in patients with dual incontinence, more evidence is needed. The goal of our study therefore, is to observe the effect of standard of care antimuscarinic therapy for UUI on fecal incontinence symptoms in women with dual incontinence. Investigators will compare patient reported fecal incontinence symptoms before and after treatment in women with dual incontinence who elect to undergo standard of care medical management for UUI with the antimuscarinic medication darifenacin.
Hypothesis: In patients with dual incontinence, treatment of urgency urinary incontinence with darifenacin 7.5mg will improve FI symptom severity at 8 weeks Primary Aim: To characterize change in FI symptom severity (change in Vaizey score) after darifenacin treatment in patients with dual incontinence at 8 weeks
Secondary Aims:
Secondary Aim #1: To characterize post-treatment change in FI frequency using 7-day bowel diaries, change in quality of life (change in Fecal Incontinence Quality of Life (FIQOL) total and subscale scores), and characterize treatment improvement using the Patient Global Impression of Improvement (PGI-I) measure Secondary Aim #2: To describe compliance and adverse effects of antimuscarinic medication in patients with dual incontinence.
Secondary Aim #3: To describe effect of antimuscarinic medication on OAB symptom bother and quality of life in patients with dual incontinence, using the OAB questionnaire short form (OAB-q SF)
- Conditions
- Urinary Incontinence, Urge, Fecal Incontinence
- Keywords
- antimuscarinic medication, medical management, dual incontinence, darifenacin, quality of life, bowel diary
- Medical subject headings
- Urinary Incontinence, Urge, Fecal Incontinence
What is being measured
The primary outcome is the main question the study is designed to answer.
change in FI symptom severity
to be measured by questionnaire and bowel diary Questionnaire to be used is the Vaizey scale which measures fecal incontinence severity. Minimum score is 0 (perfect continence; best) and maximum score is 24 (total incontinence; worse). There is no subscale.
Bowel diary is a weeklong record of each bowel movement the patient has. there is no standardized scoring or scale.
Measured: 8 weeks
Secondary outcomes (1)
post-treatment change in FI frequency
to be measured by bowel diary
Bowel diary is a weeklong record of each bowel movement the patient has. there is no standardized scoring or scale.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start21 May 2018
- Primary completion18 Jan 2019
- Study completion18 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence, UrgeStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, Lindsay M Kissane, University of Alabama at Birmingham
- Investigators
- Lindsay M Kissane, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543566
- Sponsor's protocol ID
- IRB-300000103
- Acronym
- BAMA
- Status last verified
- Jan 2019
- First submitted
- 20 Mar 2018
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaplan SA, Dmochowski R, Cash BD, Kopp ZS, Berriman SJ, Khullar V. Systematic review of the relationship between bladder and bowel function: implications for patient management. Int J Clin Pract. 2013 Mar;67(3):205-16. doi: 10.1111/ijcp.12028.
PubMed 23409689Khullar V, Damiano R, Toozs-Hobson P, Cardozo L. Prevalence of faecal incontinence among women with urinary incontinence. Br J Obstet Gynaecol. 1998 Nov;105(11):1211-3. doi: 10.1111/j.1471-0528.1998.tb09978.x.
PubMed 9853773Coyne KS, Cash B, Kopp Z, Gelhorn H, Milsom I, Berriman S, Vats V, Khullar V. The prevalence of chronic constipation and faecal incontinence among men and women with symptoms of overactive bladder. BJU Int. 2011 Jan;107(2):254-61. doi: 10.1111/j.1464-410X.2010.09446.x.
PubMed 20590548Lawrence JM, Lukacz ES, Nager CW, Hsu JW, Luber KM. Prevalence and co-occurrence of pelvic floor disorders in community-dwelling women. Obstet Gynecol. 2008 Mar;111(3):678-85. doi: 10.1097/AOG.0b013e3181660c1b.
PubMed 18310371Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006 Dec;50(6):1306-14; discussion 1314-5. doi: 10.1016/j.eururo.2006.09.019. Epub 2006 Oct 2.
PubMed 17049716Milsom I, Abrams P, Cardozo L, Roberts RG, Thuroff J, Wein AJ. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int. 2001 Jun;87(9):760-6. doi: 10.1046/j.1464-410x.2001.02228.x.
PubMed 11412210Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R, Hunt TL, Wein AJ. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003 May;20(6):327-36. doi: 10.1007/s00345-002-0301-4. Epub 2002 Nov 15.
PubMed 12811491Kannan H, Radican L, Turpin RS, Bolge SC. Burden of illness associated with lower urinary tract symptoms including overactive bladder/urinary incontinence. Urology. 2009 Jul;74(1):34-8. doi: 10.1016/j.urology.2008.12.077. Epub 2009 May 9.
PubMed 19428076Darkow T, Fontes CL, Williamson TE. Costs associated with the management of overactive bladder and related comorbidities. Pharmacotherapy. 2005 Apr;25(4):511-9. doi: 10.1592/phco.25.4.511.61033.
PubMed 15977912Wu JM, Hundley AF, Fulton RG, Myers ER. Forecasting the prevalence of pelvic floor disorders in U.S. Women: 2010 to 2050. Obstet Gynecol. 2009 Dec;114(6):1278-1283. doi: 10.1097/AOG.0b013e3181c2ce96.
PubMed 19935030Brown HW, Wexner SD, Segall MM, Brezoczky KL, Lukacz ES. Quality of life impact in women with accidental bowel leakage. Int J Clin Pract. 2012 Nov;66(11):1109-16. doi: 10.1111/ijcp.12017.
PubMed 23067035Smith TM, Menees SB, Xu X, Saad RJ, Chey WD, Fenner DE. Factors associated with quality of life among women with fecal incontinence. Int Urogynecol J. 2013 Mar;24(3):493-9. doi: 10.1007/s00192-012-1889-6. Epub 2012 Jul 18.
PubMed 22806489Soligo M, Salvatore S, Milani R, Lalia M, Malberti S, Digesu GA, Mariani S. Double incontinence in urogynecologic practice: a new insight. Am J Obstet Gynecol. 2003 Aug;189(2):438-43. doi: 10.1067/s0002-9378(03)00466-6.
PubMed 14520214Lacima G, Espuna M, Pera M, Puig-Clota M, Quinto L, Garcia-Valdecasas JC. Clinical, urodynamic, and manometric findings in women with combined fecal and urinary incontinence. Neurourol Urodyn. 2002;21(5):464-9. doi: 10.1002/nau.10025.
PubMed 12232882Markland AD, Goode PS, Burgio KL, Redden DT, Richter HE, Sawyer P, Allman RM. Correlates of urinary, fecal, and dual incontinence in older African-American and white men and women. J Am Geriatr Soc. 2008 Feb;56(2):285-90. doi: 10.1111/j.1532-5415.2007.01509.x. Epub 2007 Dec 7.
PubMed 18070007
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimuscarinic Medication for Urgency Urinary Incontinence in Women With Dual Incontinence (Darifenacin for Treatment of Women With Dual Incontinence)
- ClinicalTrials.gov ID
- NCT03543566
- Acronym / sponsor ID
- BAMA / IRB-300000103
- Conditions
- Urinary Incontinence, Urge, Fecal Incontinence
- Keywords
- antimuscarinic medication, medical management, dual incontinence, darifenacin, quality of life, bowel diary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- 21 May 2018 (actual)
- Primary completion
- 18 Jan 2019 (actual)
- Study completion
- 18 Jan 2019 (actual)
- First posted
- 1 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational research study will examine whether a medication known as darifenacin (Enablex ®) used for urgency urinary incontinence (UUI) also helps to improve fecal incontinence symptoms. Darifenacin is FDA approved for UUI, but is not FDA approved for fecal incontinence or specifically for dual incontinence (treatment of urinary incontinence and fecal incontinence at the same time). If participants are eligible for this study, they will have had symptoms of bothersome urgency urinary incontinence and fecal incontinence, and have decided to try medication for urgency urinary incontinence. Darifenacin (Enablex ®) is an oral medication which relaxes the bladder muscle to help prevent urgency urinary leakage. It is commonly used to treat overactive bladder and urgency urinary leakage. There is some evidence that this medication may also help with fecal incontinence by slowing the gut and preventing loose stools. Investigators are planning to enroll approximately 30 patients who have both UUI and fecal incontinence and who choose medical treatment as a part of their standard care.
Detailed description
Urgency urinary incontinence (UUI) and fecal incontinence (FI) are two highly prevalent pelvic floor disorders which negatively impact quality of life (QOL). Among women with urgency urinary incontinence (UUI), 8-20% also suffer from FI.
Initial management of both UUI and FI consists of behavioral therapies with or without pharmacologic management. First line management of FI includes diet, fluid and fiber intake adjustments (Grade A), antidiarrheal medication (Grade B) and exercises to strengthen and enhance awareness of the anal sphincter (Grade C). If symptoms fail to improve with these measures by 8-12 weeks, further investigations should be considered before moving to more invasive management options such as bulking agents, sphincterplasty or sacral nerve stimulation.
In addition to fiber and antidiarrheals, medications with antimuscarinic effects such as hyoscyamine and tricyclic antidepressants are often used in the treatment of FI and IBS-D. Antimuscarinic medications function in this setting by blockade of colonic muscarinic acetylcholine receptors causing smooth muscle relaxation, decreased gut motility and prolonged colon transit time.
In patients with overactive bladder (OAB) with UUI, anti-muscarinic medications or a β3-adrenoreceptor agonist medication can be added to behavioral therapy as first line to optimize symptom control and QOL (Gormley 2015). In patients being treated for UUI, constipation is often viewed as an unwanted side effect of antimuscarinic medications, with varying constipation rates observed among the different medications. Non-selective antimuscarinic medications such as fesoterodine (Toviaz ®) and tolterodine (Detrol ®) may be less likely to cause constipation, whereas newer M2 or M3-selective agents such as darifenacin (Enablex ®), solifencin (Vesicare®) or trospium (Sanctura ®) may be more constipating. Darifenacin is notable for the highest constipation rates- up to 15% for the 7.5mg dose, and up to 21% for the 15mg dose.
While there is no current evidence for one specific antimuscarinic medication use in patients suffering with dual incontinence (specifically UUI and FI), many providers use the more constipating antimuscarinic medications as treatment in this setting. Patients with loose-stool-predominant FI may benefit from the constipating side effects by slowed colonic transit time, firmer bowel movements and thereby improved bowel-related QOL. Only one study has previously examined the effect of antimuscarinic medication for OAB on bowel-related QOL. In this descriptive study, 90 patients who were treated with antimuscarinic medication for OAB were followed to measure change in ePAQ (electronic Personal Assessment Questionnaire) score. Investigators reported significant improvement in bowel-related QOL three to six months after treatment. Authors did not specify pre-treatment diagnoses, symptoms or details of the antimuscarinic treatment.
While anecdotally antimuscarinic medications are an effective first line medication in patients with dual incontinence, more evidence is needed. The goal of our study therefore, is to observe the effect of standard of care antimuscarinic therapy for UUI on fecal incontinence symptoms in women with dual incontinence. Investigators will compare patient reported fecal incontinence symptoms before and after treatment in women with dual incontinence who elect to undergo standard of care medical management for UUI with the antimuscarinic medication darifenacin.
Hypothesis: In patients with dual incontinence, treatment of urgency urinary incontinence with darifenacin 7.5mg will improve FI symptom severity at 8 weeks Primary Aim: To characterize change in FI symptom severity (change in Vaizey score) after darifenacin treatment in patients with dual incontinence at 8 weeks
Secondary Aims:
Secondary Aim #1: To characterize post-treatment change in FI frequency using 7-day bowel diaries, change in quality of life (change in Fecal Incontinence Quality of Life (FIQOL) total and subscale scores), and characterize treatment improvement using the Patient Global Impression of Improvement (PGI-I) measure Secondary Aim #2: To describe compliance and adverse effects of antimuscarinic medication in patients with dual incontinence.
Secondary Aim #3: To describe effect of antimuscarinic medication on OAB symptom bother and quality of life in patients with dual incontinence, using the OAB questionnaire short form (OAB-q SF)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients presenting to UAB urogynecology and continence clinics
Key inclusion criteria (2 listed)
- Women ≥18yrs presenting to UAB urogynecology and continence clinics with co-occurring UUI and FI
- Willing to complete all study related items
Key exclusion criteria (11 listed)
- Severe constipation, fecal impaction or overflow fecal incontinence
- Inflammatory bowel disease, colorectal CA, spinal cord injury, multiple sclerosis, stroke, myasthenia gravis
- Infectious diarrhea
- Bothersome SUI (defined as "moderately" or greater bother on UDI-3)
- Patients planning to undergo surgery during study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in FI symptom severity
Time frame: 8 weeks
to be measured by questionnaire and bowel diary Questionnaire to be used is the Vaizey scale which measures fecal incontinence severity. Minimum score is 0 (perfect continence; best) and maximum score is 24 (total incontinence; worse). There is no subscale. Bowel diary is a weeklong record of each bowel movement the patient has. there is no standardized scoring or scale.
1 secondary outcome
post-treatment change in FI frequency
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Background: PubMed 23409689Kaplan SA, Dmochowski R, Cash BD, Kopp ZS, Berriman SJ, Khullar V. Systematic review of the relationship between bladder and bowel function: implications for patient management. Int J Clin Pract. 2013 Mar;67(3):205-16. doi: 10.1111/ijcp.12028.
- Background: PubMed 9853773Khullar V, Damiano R, Toozs-Hobson P, Cardozo L. Prevalence of faecal incontinence among women with urinary incontinence. Br J Obstet Gynaecol. 1998 Nov;105(11):1211-3. doi: 10.1111/j.1471-0528.1998.tb09978.x.
- Background: PubMed 20590548Coyne KS, Cash B, Kopp Z, Gelhorn H, Milsom I, Berriman S, Vats V, Khullar V. The prevalence of chronic constipation and faecal incontinence among men and women with symptoms of overactive bladder. BJU Int. 2011 Jan;107(2):254-61. doi: 10.1111/j.1464-410X.2010.09446.x.
- Background: PubMed 18310371Lawrence JM, Lukacz ES, Nager CW, Hsu JW, Luber KM. Prevalence and co-occurrence of pelvic floor disorders in community-dwelling women. Obstet Gynecol. 2008 Mar;111(3):678-85. doi: 10.1097/AOG.0b013e3181660c1b.
- Background: PubMed 17049716Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006 Dec;50(6):1306-14; discussion 1314-5. doi: 10.1016/j.eururo.2006.09.019. Epub 2006 Oct 2.
- Background: PubMed 11412210Milsom I, Abrams P, Cardozo L, Roberts RG, Thuroff J, Wein AJ. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int. 2001 Jun;87(9):760-6. doi: 10.1046/j.1464-410x.2001.02228.x.
- Background: PubMed 12811491Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R, Hunt TL, Wein AJ. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003 May;20(6):327-36. doi: 10.1007/s00345-002-0301-4. Epub 2002 Nov 15.
- Background: PubMed 19428076Kannan H, Radican L, Turpin RS, Bolge SC. Burden of illness associated with lower urinary tract symptoms including overactive bladder/urinary incontinence. Urology. 2009 Jul;74(1):34-8. doi: 10.1016/j.urology.2008.12.077. Epub 2009 May 9.
- Background: PubMed 15977912Darkow T, Fontes CL, Williamson TE. Costs associated with the management of overactive bladder and related comorbidities. Pharmacotherapy. 2005 Apr;25(4):511-9. doi: 10.1592/phco.25.4.511.61033.
- Background: PubMed 19935030Wu JM, Hundley AF, Fulton RG, Myers ER. Forecasting the prevalence of pelvic floor disorders in U.S. Women: 2010 to 2050. Obstet Gynecol. 2009 Dec;114(6):1278-1283. doi: 10.1097/AOG.0b013e3181c2ce96.
- Background: PubMed 23067035Brown HW, Wexner SD, Segall MM, Brezoczky KL, Lukacz ES. Quality of life impact in women with accidental bowel leakage. Int J Clin Pract. 2012 Nov;66(11):1109-16. doi: 10.1111/ijcp.12017.
- Background: PubMed 22806489Smith TM, Menees SB, Xu X, Saad RJ, Chey WD, Fenner DE. Factors associated with quality of life among women with fecal incontinence. Int Urogynecol J. 2013 Mar;24(3):493-9. doi: 10.1007/s00192-012-1889-6. Epub 2012 Jul 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsay M Kissane, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence, Urge and Fecal Incontinence, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in FI symptom severity (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03543566, which also lists 40 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2019.