loperamide and Fecal Incontinence

loperamide has been researched along with Fecal Incontinence in 35 studies

Loperamide: One of the long-acting synthetic ANTIDIARRHEALS; it is not significantly absorbed from the gut, and has no effect on the adrenergic system or central nervous system, but may antagonize histamine and interfere with acetylcholine release locally.
loperamide : A synthetic piperidine derivative, effective against diarrhoea resulting from gastroenteritis or inflammatory bowel disease.

Fecal Incontinence: Failure of voluntary control of the anal sphincters, with involuntary passage of feces and flatus.

Research

Studies (35)

Authors

Clinical Trials (5)

Trial Overview

Trial Outcomes

Number of Urge Urinary Incontinence (UUI) Episodes

The primary outcome is the change from baseline in mean number of UUI episodes over the first 6-month visit period (1, 2, 3, 4, 5 and 6 month assessments); and is measured using 3-day bladder diaries administered monthly for the first 6 month visit period. (NCT01502956)
Timeframe: 6 Months

Quality of Life (HUI-3)

Change from baseline in quality of life measures over the first 6 month visit period (6 month assessment) as measured by the Health Utility Index, Version 3 (HUI-3). The HUI 3 scale has a range from 0 to 1 with higher scores representing better health. (NCT01502956)
Timeframe: 6 Months

Quality of Life (IIQ-SF)

Change from baseline in quality of life measures over the first 6 month visit period (6 month assessment) as measured by the change in the mean Incontinence Impact Questionnaire short form (IIQ-SF) score. The IIQ-SF scale has a range from 0 to 100 with higher scores indicating a worse quality of life. (NCT01502956)
Timeframe: 6 Months

Quality of Life (UDI-SF)

Change from baseline in quality of life measures over the first 6 month visit period (6 month assessment) as measured by the change in mean Urinary Distress Inventory Short Form (UDI-SF) score. The UDI-SF scale has a range from 0 to 100 with higher scores indicating greater distress. (NCT01502956)
Timeframe: 6 Months

Treatment Satisfaction (OAB-SATq Treatment Preference)

"Treatment preference as measured by the Overactive Bladder Satisfaction of Treatment Questionnaire (OAB-SATq) at 6 months (6 month assessment).OAB-SATq treatment preference is a binary outcome that is classified as yes if a participant answers either Slight preference for the treatment I am receiving now or Definitely prefer the treatment I am receiving now to the question Do you prefer the treatment that you received since entering this study to the treatment you received before the study?" (NCT01502956)
Timeframe: 6 Months

Change in Overactive Bladder

Change in mean Overactive Bladder Questionnaire Short Form (OABq-SF) score throughout baseline to the first 6-month visit (1, 2, 3, 4, 5, and 6-month assessments). Values range from 0 to 100 with higher scores on the symptom scale indicating greater severity of symptoms and higher scores on the quality of life scale indicating a better quality of life. (NCT01502956)
Timeframe: 6 Months

Number of Participants With Improvement of Bladder Function and Urinary Leakage

Proportion of subjects who report adequate improvement of their bladder function and urinary leakage with the Patient Global Impression of Improvement Questionnaire (PGI-I) at 6 months. Adequate improvement is defined as a rating of 1, 2, or 3 (better) on the patient-reported measure of perceived improvement with treatment on a scale of 1 (very much better) to 7 (very much worse). (NCT01502956)
Timeframe: 6 Months

Severity of Urge Incontinence Symptoms

Severity of urge incontinence symptoms at 6 month visit period as measured by the Sandvik questionnaire. The Sandvik score is a patient-reported measure of incontinence severity as assessed on a scale of slight (1-2), moderate (3-6), severe (8-9), very severe (12) to severe (10-12) using a standard scoring algorithm. (NCT01502956)
Timeframe: 6 Months

Treatment Satisfaction (OAB-SATq Treatment Satisfaction, Adverse Effects, Treatment Endorsement, and Convenience)

Treatment satisfaction as measured by the mean Overactive Bladder Satisfaction of Treatment Questionnaire (OAB-SATq) score at 6 months (6 month assessment). The OAB-SATq score ranges from 0 to 100 and includes 5 subscales: treatment satisfaction, side effects, treatment endorsement, convenience, and treatment preference, with higher scores reflecting better satisfaction. (NCT01502956)
Timeframe: 6 months

Urinary Frequency and Nocturia

Change in mean number of urinary incontinence episodes (any type) and nocturia episodes from baseline over the first 6-month visit period (1, 2, 3, 4, 5, and 6-month assessments) as measured by the 3 day bladder diary. (NCT01502956)
Timeframe: 6 Months

Change From Baseline Accident-free Days at 12 and 24 Weeks

Based on data collected from participant-completed diaries at baseline and 12 and 24 weeks, the outcome variable is computed as the difference in number of accident-free days at 12 and 24 weeks and the number of accident-free days at baseline. Only valid diaries were included in the analyses (e.g. completion of all 7 days for baseline and at least 3 complete days, not necessarily consecutive, for follow-up diaries). (NCT02008565)
Timeframe: 12 and 24 weeks

Change From Baseline Maximum Anal Pressures During Squeeze With the Catheter at the HPZ at 12 and 24 Weeks

Based on data collected from the manometry form, the outcome variable will be computed as the difference in maximum anal pressures during squeeze with the catheter at the high pressure zone (HPZ) at 12 and 24 weeks and maximum anal pressures during squeeze with the catheter at the HPZ at baseline. (NCT02008565)
Timeframe: 12 and 24 weeks

Change From Baseline Pad-change Leaks Per Day at 12 and 24 Weeks

Based on data collected from participant-completed diaries at baseline and 12 and 24 weeks, the outcome variable is computed as the difference in number of fecal incontinence episodes per day resulting in a change in pad, clothes or underwear at 12 and 24 weeks and the number of fecal incontinence episodes resulting in a change in pad, clothes or underwear at baseline. Only valid diaries were included in the analyses (e.g. completion of all 7 days for baseline and at least 3 complete days, not necessarily consecutive, for follow-up diaries). (NCT02008565)
Timeframe: 12 and 24 weeks

Change From Baseline Pad-change Leaks Per Week at 12 and 24 Weeks

Based on data collected from participant-completed diaries at baseline and 12 and 24 weeks, the outcome variable is computed as the difference in number of fecal incontinence episodes per week resulting in a change in pad, clothes or underwear at 12 and 24 weeks and the number of fecal incontinence episodes resulting in a change in pad, clothes or underwear at baseline. Only valid diaries were included in the analyses (e.g. completion of all 7 days for baseline and at least 3 complete days, not necessarily consecutive, for follow-up diaries). (NCT02008565)
Timeframe: 12 and 24 weeks

Change From Baseline Resting Anal Canal Pressures (mm of Hg) at 2 cm, 1 cm, and 0 cm Insertion at 12 and 24 Weeks

Based on data collected from the manometry form, the outcome variable is computed as the difference in resting anal canal pressures (mm Hg) at 2 cm, 1 cm, and 0 cm insertion at 12 and 24 weeks and resting anal canal pressures (mm Hg) at 2 cm, 1 cm, and 0 cm insertion at baseline (NCT02008565)
Timeframe: 12 and 24 weeks

Change From Baseline St. Mark's (Vaizey) Score

"The primary outcome measure for all study arms is the change from baseline in St. Mark's (Vaizey) Score 24 weeks after treatment initiation to compare the marginal outcomes of anal exercise with biofeedback to usual care and loperamide to placebo.~The St. Mark's (Vaizey) score, published in 1999, is commonly used in clinical studies and reports and was based on the Jorge-Wexner score but added two further items for assessment: the use of constipating medication and the presence of fecal urgency. Minimum score is 0 = perfect continence; maximum score is 24 = totally incontinent." (NCT02008565)
Timeframe: 12 and 24 weeks

Change From Baseline Total Number of Leaks Per Day at 12 and 24 Weeks

Based on data collected from participant-completed diaries at baseline and 12 and 24 weeks, the outcome variable is computed as the difference in daily average FI episodes at 12 and 24 weeks and the daily average FI episodes at baseline. Only valid diaries were included in the analyses (e.g. completion of all 7 days for baseline and at 3 complete days, not necessarily consecutive, for follow-up diaries). (NCT02008565)
Timeframe: 12 and 24 weeks

Change From Baseline Volume of Air (mL) at First Sensation for Perception of Rectal Distention at 12 and 24 Weeks

Based on data collected from the manometry form, the outcome variable is computed as the difference in volume of air (mL) at first sensation for perception of rectal distention at 12 and 24 weeks and volume of air (mL) at first sensation for perception of rectal distention at baseline. (NCT02008565)
Timeframe: 12 and 24 weeks

Change From Baseline Volume of Air (mL) at Urge to Defecate at 12 and 24 Weeks

Based on data collected from the manometry form, the outcome variable is computed as the difference in maximum tolerable rectal volume of air (mL) at 12 and 24 weeks and maximum tolerable rectal volume of air (mL) at baseline. (NCT02008565)
Timeframe: 12 and 24 weeks

Change in Colorectal-Anal Subscale of the Pelvic Floor Impact Questionnaire Short Form (CRAIQ) Score

The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on the CRAIQ is 0-3 with (0) Not at all, (1) Somewhat, (2) Moderately, and (3), Quite a bit. Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [12, 24] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. (NCT02008565)
Timeframe: 12 and 24 weeks

Change in Fecal Incontinence Severity Index (FISI) Score

"The Modified Manchester Health Questionnaire (MMHQ) includes the 4-item Fecal Incontinence Severity Index (FISI), which measures the severity of liquid, solid, mucus, or gas incontinence that occurs from 2 or more times per day, once per day, 2 or more times per week, once a week, to 1-3 times per month. Patient-weighted scores were used to determine severity and scores ranged from 0-61, with higher scores indicating worse fecal incontinence (FI) severity. An FISI score of 0 indicated continence." (NCT02008565)
Timeframe: 12 and 24 weeks

Change in Quality of Life on Colorectal-Anal Distress Inventory (CRADI)

The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1) Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2) Colorectal Anal Distress Inventory (range: 0-100), and 3) Urinary Distress Inventory (range: 0-100). The range of responses on the CRADI is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25 for the scale. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress). Change = (Week [12, 24] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. (NCT02008565)
Timeframe: 12 and 24 weeks

Participants With Improvement in Patient Global Impression of Improvement (PGI-I) Score

The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better), 2 (much better), or 3 (a little better). (NCT02008565)
Timeframe: 12 and 24 Weeks

Reviews

6 reviews available for loperamide and Fecal Incontinence

Trials

13 trials available for loperamide and Fecal Incontinence

Other Studies

16 other studies available for loperamide and Fecal Incontinence