Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neuromodulation for Accidental Bowel Leakage (NOTABLe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03278613
Recruitment Status : Completed
First Posted : September 11, 2017
Results First Posted : May 14, 2021
Last Update Posted : May 14, 2021
Sponsor:
Collaborators:
University of Alabama at Birmingham
University of California, San Diego
Duke University
Women and Infants Hospital of Rhode Island
RTI International
University of Pennsylvania
University of Pittsburgh
Kaiser Permanente
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
NICHD Pelvic Floor Disorders Network

Tracking Information
First Submitted Date  ICMJE September 6, 2017
First Posted Date  ICMJE September 11, 2017
Results First Submitted Date  ICMJE March 24, 2021
Results First Posted Date  ICMJE May 14, 2021
Last Update Posted Date May 14, 2021
Actual Study Start Date  ICMJE February 9, 2018
Actual Primary Completion Date March 9, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2021)
Change From Baseline St. Mark's (Vaizey) Score [ Time Frame: 4, 8, and 12 Weeks ]
The primary outcome measure is the change from baseline in St. Mark's (Vaizey) Score 12 weeks after treatment initiation to compare the outcomes of post-tibial nerve stimulation (PTNS) versus sham stimulation. 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. Change from baseline is calculated as Week [4, 8, or 12] Score minus the score at baseline.
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2017)
St. Mark's (Vaizey) Score (PTNS vs. Sham) [ Time Frame: 12 weeks, 1 year ]
Change from baseline St. Mark's (Vaizey) Score after 12 weeks of stimulation and after 1 year of treatment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2021)
  • Responder to Treatment [ Time Frame: 4, 8, and 12 Weeks ]
    Responder status is based on the primary chnage from St. Mark's Score. A responder is defined as any particpant with at least a 4 point reduction in score compared to their baseline score
  • Change From Baseline Number of Fecal Incontinence Events Per Week [ Time Frame: 8 and 12 Weeks ]
    Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of fecal incontinence episodes per week at 8 and 12 weeks and the number of fecal incontinence episodes at baseline.
  • Change From Baseline Number of Urge Fecal Incontinence Events Per Week [ Time Frame: 8 and 12 Weeks ]
    Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of urge fecal incontinence episodes per week at 8 and 12 weeks and the number of urge fecal incontinence episodes at baseline.
  • Change From Baseline Number of Bowel Movements Per Week [ Time Frame: 8 and 12 Weeks ]
    Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of bowel movements per week at 8 and 12 weeks and the number of bowel movements at baseline.
  • Change From Baseline Number of Urge Bowel Movements Per Week [ Time Frame: 8 and 12 Weeks ]
    Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of urge bowel movements per week at 8 and 12 weeks and the number of urge bowel movements at baseline.
  • Change From Baseline Number of Days Without Fecal Incontinence Episodes Per Week [ Time Frame: 8 and 12 Weeks ]
    Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of days without fecal incontinence episodes per week at 8 and 12 weeks and the number of days without fecal incontinence episodes at baseline.
  • 50% Improvement in Fecal Incontinence Episodes Per Week [ Time Frame: 8 and 12 Weeks ]
    Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome is calculated as any participant with a 50% reduction in fecal incontinence episodes per week at 8 and 12 weeks compared to the fecal incontinence episodes at baseline
  • 75% Improvement in Fecal Incontinence Episodes Per Week [ Time Frame: 8 and 12 Weeks ]
    Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome is calculated as any participant with a 75% reduction in fecal incontinence episodes per week at 8, and 12 weeks compared to the fecal incontinence episodes at baseline.
  • Patient Global Impression-Improvement [ Time Frame: 4, 8, and 12 Weeks ]
    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) or 2 (much better)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2017)
  • Episodes of fecal incontinence (FI) (PTNS vs. Sham) [ Time Frame: 12 weeks, 1 year ]
    Change from baseline 14-day bowel diary FI episodes after 12 weeks of stimulation sessions in Part 1 and after 1 year in Part 2
  • Accidental Bowel Leakage Symptom questionnaire (ABLe) score (PTNS vs. Sham) [ Time Frame: 12 weeks, 1 year ]
    Change from baseline ABLe score after 12 weeks of stimulation sessions in Part 1 and after 1 year in Part 2
  • Fecal Incontinence Quality of Life (FIQL) questionnaire score (PTNS vs. Sham) [ Time Frame: 12 weeks, 1 year ]
    Change from baseline FIQL score after 12 weeks of stimulation sessions in Part 1 and after 1 year in Part 2
  • Modified Manchester Questionnaire with Female Sexual Function Index (FSFI) (PTNS vs. Sham) [ Time Frame: 12 weeks, 1 year ]
    Change from baseline Modified Manchester FSFI score after 12 weeks of stimulation sessions in Part 1 and after 1 year in Part 2
  • Pelvic Floor Distress Inventory Questionnaire - Short Form 20 (PFDI-20) (PTNS vs. Sham) [ Time Frame: 12 weeks, 1 year ]
    Change from baseline PFDI-20 score after 12 weeks of stimulation sessions in Part 1 and after 1 year in Part 2
  • Patient Assessment Of Constipation Symptoms (PAC-SYM) Questionnaire (PTNS vs. Sham) [ Time Frame: 12 weeks, 1 year ]
    Change from baseline PAC-SYM score after 12 weeks of stimulation sessions in Part 1 and after 1 year in Part 2
  • Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) (PTNS vs. Sham) [ Time Frame: 12 weeks, 1 year ]
    Change from baseline PISQ-IR score after 12 weeks of stimulation sessions in Part 1 and after 1 year in Part 2
  • Fecal Incontinence Adaptation Index Questionnaire (PTNS vs. Sham) [ Time Frame: 12 weeks, 1 year ]
    Change from baseline FI Adaptation Index score after 12 weeks of stimulation sessions in Part 1 and after 1 year in Part 2
  • Self-reported use of constipating medications over time (PTNS vs. Sham) [ Time Frame: 12 weeks, 1 year ]
    Change in constipating medication use reported on St. Mark's (Vaizey) Score questionnaire (Question 3b) over time
  • Patient Global Impression of Improvement (PGI-I) (PTNS vs. Sham) [ Time Frame: 12 weeks, 1 year ]
    Change in PGI-I scores over time
  • Patient Global Symptom Control (PGSC) (PTNS vs. Sham) [ Time Frame: 12 weeks, 1 year ]
    Change in PGSC scores over time
  • 12-Item Short Form Health Survey (SF-12) (PTNS vs. Sham) [ Time Frame: 12 weeks, 1 year ]
    Change from baseline SF-12 score after 12 weeks of stimulation sessions in Part 1 and after 1 year in Part 2
  • PTNS Treatment Adherence and Feasibility of Treatment Schedule in Part 1 [ Time Frame: 12 weeks ]
    Percent who attend 10 of 12 scheduled PTNS treatments in Part I
  • PTNS Treatment Adherence and Feasibility of Treatment Schedule in Part 2 [ Time Frame: 1 year ]
    Percent who attend 9 of 11 sessions in Part 2 (Fixed schedule)
  • Validity of the Sham (Part 1) [ Time Frame: 12 weeks ]
    Percent correctly identifying their treatment assignment via masking assessment form
  • Rate of UTIs treated with antibiotics (PTNS vs. Sham) [ Time Frame: 12 weeks, 1 year ]
    Difference in rate between the PTNS and Sham Groups reported via the Medical History Follow-Up Form in Part 1 and Part 2
  • Cost of PTNS Maintenance Schedules [ Time Frame: 1 year ]
    Mean number of PTNS treatments/year and mean treatment interval for those receiving PTNS in Part 2 via Treatment Form
  • Ability of PFDN accidental bowel leakage (ABL) phone app diary to detect change. [ Time Frame: 12 weeks ]
    Change from baseline fecal incontinence episodes recorded on phone app diary compared to change from baseline St. Mark's score after 12 weeks of stimulation
Current Other Pre-specified Outcome Measures
 (submitted: April 22, 2021)
  • Change From Baseline ABLe Liquid Score [ Time Frame: 8 and 12 Weeks ]
    The ABLE Liquid Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of liquid stool. Minimum score is 0 = no problem with liquid stool leakage; maximum score is 4 = frequent, bothersome leakage of large amounts of liquid stool. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
  • Change From Baseline ABLe Solid Score [ Time Frame: 8 and 12 Weeks ]
    The ABLE Solid Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of solid stool. Minimum score is 0 = no problem with solid stool leakage; maximum score is 4 = frequent, bothersome leakage of large amounts of solid stool. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
  • Change From Baseline ABLe Mucus Score [ Time Frame: 8 and 12 Weeks ]
    The ABLE Mucus Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of mucus from the rectum. Minimum score is 0 = no problem with mucus leakage from the rectum; maximum score is 4 = frequent, bothersome leakage of large amounts of mucus from the rectum. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
  • Change From Baseline ABLe Gas Score [ Time Frame: 8 and 12 Weeks ]
    The ABLE Gas Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of gas from the rectum. Minimum score is 0 = no problem with gas leakage from the rectum; maximum score is 4 = frequent and bothersome leakage of gas from the rectum. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
  • Change From Baseline ABLe Predictability/Awareness Score [ Time Frame: 8 and 12 Weeks ]
    The ABLE Predictability/Awareness Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the predictability of bowel leakage events. Minimum score is 0 = no problems with leakage; maximum score is 4 = leakage without awareness or predictability. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
  • Change From Baseline ABLe Control Score [ Time Frame: 8 and 12 Weeks ]
    The ABLE Control Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the ability to control bowel movements. Minimum score is 0 = no problems with urgency to empty bowels wthout warning; maximum score is 4 = frequent and bothersome urgency to empty bowels wthout warning.
  • Change From Baseline ABLe Ancillary Bowel Symptoms Score [ Time Frame: 8 and 12 Weeks ]
    The ABLE Ancillary Bowel Symptoms Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the frequency and impact of ancially bowel symptoms. Minimum score is 0 = no problems with pain or incomplete emptying; maximum score is 4 = frequent and bothersome pain or incomplete emptying.
  • Change From Baseline ABLe Overall Score [ Time Frame: 8 and 12 Weeks ]
    The ABLE Overall Score is the summary score of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the frequency and impact of accidental bowel leakage and related symptoms. Minimum score is 0 = no problems with bowel leakage and related symptoms; maximum score is 4 = frequent and bothersome problems with bowel leakage and related symptoms.
  • Patient Global Symptom Control [ Time Frame: Baseline and 4, 8, and 12 Weeks ]
    The Patient Global Symptom Control (PGSC) is a patient-reported measure of perceived agreement that symptoms are under control, as assessed on a scale of 1 (Disagree Strongly) to 5 (Agree Strongly). Included here are participants who had reported disagreements as indicated by a rating of 1 (Disagree Strongly) or 2 (Disagree)
  • Change From Baseline FIQL Lifestyle Score [ Time Frame: 8 and 12 Weeks ]
    The FIQL Lifestyle Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
  • Change From Baseline FIQL Coping Score [ Time Frame: 8 and 12 Weeks ]
    The FIQL Coping Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
  • Change From Baseline FIQL Depression Score [ Time Frame: 8 and 12 Weeks ]
    The FIQL Depression Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
  • Change From Baseline FIQL Embarrassment Score [ Time Frame: 8 and 12 Weeks ]
    The FIQL Embarrassment Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
  • Change From Baseline FISI Patient Score [ Time Frame: 8 and 12 Weeks ]
    The FISI Patient Score is a summary score of the validated Fecal Incontinence Severity Index questionnaire which provides a summary metric of the severity of fecal incontinence from the patient's perspective. Minimum score is 0 = no fecal incontinence; maximum score is 61 = very severe fecal incontinence. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
  • Change From Baseline FISI Doctor Score [ Time Frame: 8 and 12 Weeks ]
    The FISI Doctor Score is a summary score of the validated Fecal Incontinence Severity Index questionnaire which provides a summary metric of the severity of fecal incontinence from the doctor's perspective. Minimum score is 0 = no fecal incontinence; maximum score is 57 = very severe fecal incontinence. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
  • Change From Baseline MMHQ Incontinence Impact Score [ Time Frame: 8 and 12 Weeks ]
    The MMHQ Incontinence Impact Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
  • Change From Baseline MMHQ Role Limitations Score [ Time Frame: 8 and 12 Weeks ]
    The MMHQ Role Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
  • Change From Baseline MMHQ Physical Limitations Score [ Time Frame: 8 and 12 Weeks ]
    The MMHQ Physical Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
  • Change From Baseline MMHQ Social Limitations Score [ Time Frame: 8 and 12 Weeks ]
    The MMHQ Social Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
  • Change From Baseline MMHQ Personal Relationship Score [ Time Frame: 8 and 12 Weeks ]
    The MMHQ Personal Relationship Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
  • Change From Baseline MMHQ Emotional Function Score [ Time Frame: 8 and 12 Weeks ]
    The MMHQ Emotional Function Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
  • Change From Baseline MMHQ Sleep/Energy Score [ Time Frame: 8 and 12 Weeks ]
    The MMHQ Sleep/Energy Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
  • Change From Baseline MMHQ Severity Measures Score [ Time Frame: 8 and 12 Weeks ]
    The MMHQ Severity Measures Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
  • Change From Baseline CRAIQ Score [ Time Frame: 8 and 12 Weeks ]
    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). 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 [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
  • Change From Baseline POPIQ Score [ Time Frame: 8 and 12 Weeks ]
    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). 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 [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
  • Change From Baseline UIQ Score [ Time Frame: 8 and 12 Weeks ]
    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). 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 [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
  • Change From Baseline PFIQ Score [ Time Frame: 8 and 12 Weeks ]
    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). 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 [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
  • Change From Baseline PAC-SYM Abdominal Score [ Time Frame: 12 Weeks ]
    The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.
  • Change From Baseline PAC-SYM Rectal Score [ Time Frame: 12 Weeks ]
    The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.
  • Change From Baseline PAC-SYM Stool Score [ Time Frame: 12 Weeks ]
    The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.
  • Change From Baseline PAC-SYM Total Score [ Time Frame: 12 Weeks ]
    The Patient Assessment of Constipation - Symptom (PAC-SYM) is a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-missing responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very severe). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.
  • Change From Baseline PISQ-IR NSA-PR Score [ Time Frame: 12 Weeks ]
    The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Partner Related (NSA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
  • Change From Baseline PISQ-IR NSA-CS Score [ Time Frame: 12 Weeks ]
    The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Specific (NSA-CS) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
  • Change From Baseline PISQ-IR NSA-GQA Score [ Time Frame: 12 Weeks ]
    The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Global Quality Rating (NSA-GQA) ranges from 1 to 4.5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
  • Change From Baseline PISQ-IR NSA-CI Score [ Time Frame: 12 Weeks ]
    The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Impact (NSA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
  • Change From Baseline PISQ-IR SA-AO Score [ Time Frame: 12 Weeks ]
    The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Arousal Orgasm (SA-AO) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
  • Change From Baseline PISQ-IR SA-PR Score [ Time Frame: 12 Weeks ]
    The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Partner Related (SA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
  • Change From Baseline PISQ-IR SA-CS Score [ Time Frame: 12 Weeks ]
    The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Specific (SA-CS) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
  • Change From Baseline PISQ-IR SA-GQR Score [ Time Frame: 12 Weeks ]
    The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Global Quality Rating (SA-GQR) ranges from 1 to 4.75 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
  • Change From Baseline PISQ-IR SA-CI Score [ Time Frame: 12 Weeks ]
    The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Impact (SA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
  • Change From Baseline PISQ-IR SA-D Score [ Time Frame: 12 Weeks ]
    The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Desire (SA-D) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
  • Change From Baseline PISQ-IR SA-AVG Score [ Time Frame: 12 Weeks ]
    The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Average (SA-AVG) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
  • Change From Baseline FIAI Hygiene Index Score [ Time Frame: 12 Weeks ]
    The Fecal Incontinence Adaptation Index (FIAI) is a validated form which measures the adaptation behavios resulting from fecal incontinence. It consists of two subscales: Hygiene (range: 0-100) and Avoidance (range: 0-100). Scores are cal calculated as the average of the non-missing responses multiplied by 25. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
  • Change From Baseline FIAI Avoidance Index Score [ Time Frame: 12 Weeks ]
    The Fecal Incontinence Adaptation Index (FIAI) is a validated form which measures the adaptation behavios resulting from fecal incontinence. It consists of two subscales: Hygiene (range: 0-100) and Avoidance (range: 0-100). Scores are cal calculated as the average of the non-missing responses multiplied by 25. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
  • Change From Baseline SF-12 Aggregate Physical Score [ Time Frame: 12 Weeks ]
    The 12-Item Short-Form Health Survey (SF-12) is a validated survey which assesses overall physical and mental health. The Aggregate Physical Score ranges from 24 to 56.6 with higher scores indicating greater physical health. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
  • Change From Baseline SF-12 Aggregate Mental Score [ Time Frame: 12 Weeks ]
    The 12-Item Short-Form Health Survey (SF-12) is a validated survey which assesses overall physical and mental health. The Aggregate Mental Score ranges from 19.06 to 60.86 with higher scores indicating greater mental health. The outcome is calculated as the difference in score at 12 weeks and the score at baseline
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuromodulation for Accidental Bowel Leakage
Official Title  ICMJE Neuromodulation for Accidental Bowel Leakage
Brief Summary

This study is a multi-center, randomized clinical trial of women with refractory accidental bowel leakage (ABL) symptoms who have failed to achieve satisfactory symptom control from 2 first-line treatments for ABL: supervised pelvic muscle training (PMT) and constipating medication. The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to a validated sham to determine if PTNS is effective for the treatment of fecal incontinence (FI) in women.

The investigators will test the null hypothesis that change from baseline in St. Mark's (Vaizey) score after 12 weeks of stimulation is not significantly different in women with symptomatic ABL receiving PTNS treatments compared to women receiving sham PTNS treatments.

Detailed Description

The overarching goal of this randomized clinical trial is to determine if PTNS is more effective than sham PTNS for the treatment of FI in women after 12 weeks of treatment and 1 year after initiating treatment. This is a two-part trial with a Run-In Phase prior to randomization. The trial has the following primary aim:

To determine whether the change from baseline in St. Mark's (Vaizey) score in women with symptomatic ABL undergoing PTNS differs from sham after 12 weeks of stimulation.

Additional secondary aims include:

  1. To compare changes from baseline in self-reported functional outcomes after 12 weekly stimulation sessions in both PTNS and sham groups in Part 1.
  2. To determine whether symptom relief amongst study "responders" can be sustained for one year with maintenance treatments in Part II.
  3. To determine the impact of completing a bowel diary and receiving education on FI on symptom severity.
  4. To determine the ability of the PFDN ABL phone app bowel diary to detect changes from baseline in fecal incontinence episodes recorded to after 12 weeks of stimulation sessions.
  5. To determine the association between St. Mark's score and both fat and fiber intake alone and in combination.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description:
Participants will remain masked to subject treatment assignment throughout the trial. To maintain masking of participants, the duration of treatment sessions for both the PTNS and sham groups will be 30 minutes and will be conducted with subjects in a supine position with the knees comfortably abducted and flexed. The leg and foot involved in treatment will be obscured from the subject's view with a portable anesthesia drape frame to which an exam sheet will be secured.
Primary Purpose: Treatment
Condition  ICMJE
  • Fecal Incontinence
  • Bowel Incontinence
Intervention  ICMJE Device: ES-130
The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Study Arms  ICMJE
  • Experimental: Percutaneous Tibial Nerve Stimulation (PTNS)
    PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.
    Intervention: Device: ES-130
  • Sham Comparator: Validated Sham
    Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.
    Intervention: Device: ES-130
Publications * Zyczynski HM, Arya LA, Lukacz ES, Richter HE, Rahn DD, Sung VW, Visco AG, Shaffer A, Jelovsek JE, Rogers R, Mazloomdoost D, Gantz MG; Eunice Kennedy Shriver NICHD Pelvic Floor Disorders Network (PFDN). Design of a Randomized Controlled Trial of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of Refractory Fecal Incontinence in Women: The NeurOmodulaTion for Accidental Bowel Leakage Study. Female Pelvic Med Reconstr Surg. 2021 Dec 1;27(12):726-734. doi: 10.1097/SPV.0000000000001050.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 30, 2020)
166
Original Estimated Enrollment  ICMJE
 (submitted: September 7, 2017)
359
Actual Study Completion Date  ICMJE March 9, 2020
Actual Primary Completion Date March 9, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women ≥ 18 years of age
  • FI symptoms ≥ 3 months
  • Baseline St. Mark's score of ≥ 12
  • Attended ≥ 2 supervised PMT for ABL
  • Intolerance, unwillingness, or inadequate response to constipating medications
  • Current negative colon cancer screening based on the USPSTF's recommendation for colorectal cancer screening (2016)

Exclusion Criteria:

  • Previous PTNS treatment
  • History of uncontrolled diarrhea in the past 3 months (usual or most common stool type over the preceding 3 months of 7 on the Bristol Stool Form Scale)
  • History of severe constipation in the past 3 months (usual or most common stool type over the preceding 3 months of 1 on the Bristol Stool Form Scale)
  • History of inflammatory bowel disease (includes Crohn's disease and ulcerative colitis, but does not include irritable bowel disease)
  • Unrepaired rectovaginal fistula/chronic 4th degree laceration
  • Full thickness rectal prolapse
  • History of congenital anorectal malformation
  • History of bowel resection surgery for any indication
  • Minor anal procedures within 6 months for treatment of ABL (injection of bulking agent or radiofrequency energy) or ligation of hemorrhoids
  • Prior pelvic or abdominal radiation
  • Diagnosis of cancer of the descending colon or anus
  • Diagnosis of cancer in the region where the PTNS or sham needles or surface electrodes would be placed
  • Pacemaker, implantable defibrillator
  • Current use of Interstim sacral nerve stimulator or TENS in the pelvic region, back, or legs
  • Clinically significant neurological disorders known to affect anal continence
  • Coagulopathy
  • Severe peripheral edema preventing accurate placement of PTNS needles
  • Chronic swollen, infected, inflamed skin or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins) in the region where the PTNS or sham needles or surface electrodes would be placed
  • Metal implant in foot/toes near TENS electrode location
  • Marked sensory deficit (numbness) of feet or ankles in the region where the PTNS or sham needles or surface electrodes would be placed
  • Childbirth within the last 3 months
  • Pregnant or planning to become pregnant during the study duration 1 year; a urine pregnancy test will be performed and must be negative by the first intervention visit if the participant is of childbearing potential
  • Unwilling to use acceptable form of contraceptive if the participant is of childbearing potential
  • Participation in another intervention trial impacting bowel function
  • Inability to provide informed consent, complete questionnaires independently, or to attend intervention sessions
  • Unable or unwilling to complete the bowel diary in Run-In Phase (valid diary defined as data from ≥ 10 of 14 days with minimum of 3 consecutive days per week)
  • Unwilling to download bowel diary app onto smartphone if the participant owns a smartphone
  • Visual impairment prohibiting reading the paper diary, the smart phone screen
  • Unable to speak, read, or write in English or Spanish at a basic level
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03278613
Other Study ID Numbers  ICMJE 12865-29
2U24HD069031-06 ( U.S. NIH Grant/Contract )
2UG1HD069013-06 ( U.S. NIH Grant/Contract )
5UG1HD041267-18 ( U.S. NIH Grant/Contract )
5UG1HD069010-07 ( U.S. NIH Grant/Contract )
5UG1HD069006-07 ( U.S. NIH Grant/Contract )
5UG1HD041261-17 ( U.S. NIH Grant/Contract )
5UG1HD054214-12 ( U.S. NIH Grant/Contract )
5UG1HD054241-12 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party NICHD Pelvic Floor Disorders Network
Study Sponsor  ICMJE NICHD Pelvic Floor Disorders Network
Collaborators  ICMJE
  • University of Alabama at Birmingham
  • University of California, San Diego
  • Duke University
  • Women and Infants Hospital of Rhode Island
  • RTI International
  • University of Pennsylvania
  • University of Pittsburgh
  • Kaiser Permanente
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of Texas Southwestern Medical Center
Investigators  ICMJE
Study Chair: Halina M Zyczynski, MD Magee-Women's Hospital, Department of Obstetrics and Gynecology
PRS Account NICHD Pelvic Floor Disorders Network
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP