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Sacral Nerve Stimulation in Treating Low Anterior Resection Syndrome or Fecal Incontinence in Patients With Locally Advanced Rectal Cancer or Other Pelvic Cancer, the RESTORE Study

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04066894
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Brief Summary:
This trial studies how well sacral nerve stimulation works in treating low anterior resection syndrome or fecal incontinence (the body's passage of stool without control) in patients with rectal cancer that has spread to nearby tissues or lymph nodes, or other pelvic cancer. Sacral nerve stimulation is a permanent implant that may improve bowel functions by stimulating the nerves that control the muscles related to bowel function.

Condition or disease Intervention/treatment Phase
Fecal Incontinence Low Anterior Resection Syndrome Malignant Anal Neoplasm Malignant Bladder Neoplasm Malignant Cervical Neoplasm Malignant Ovarian Neoplasm Malignant Pelvic Neoplasm Malignant Prostate Neoplasm Malignant Uterine Neoplasm Malignant Vaginal Neoplasm Malignant Vulvar Neoplasm Rectal Adenocarcinoma Stage III Rectal Cancer AJCC v8 Stage IIIA Rectal Cancer AJCC v8 Stage IIIB Rectal Cancer AJCC v8 Stage IIIC Rectal Cancer AJCC v8 Stage IV Rectal Cancer AJCC v8 Stage IVA Rectal Cancer AJCC v8 Stage IVB Rectal Cancer AJCC v8 Stage IVC Rectal Cancer AJCC v8 Procedure: Explantation Other: Quality-of-Life Assessment Other: Questionnaire Administration Device: Sacral Nerve Stimulator Device: Sacral Nerve Stimulator Battery Procedure: Therapeutic Conventional Surgery Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To investigate the efficacy of sacral nerve stimulator placement in patients with fecal incontinence (FI) or low anterior resection syndrome (LARS) who have previously undergone chemoradiation treatment and/or a restorative partial or complete proctectomy with colorectal or coloanal anastomosis for cancer treatment as per standard of care (restorative surgery cohort).

II. To evaluate the feasibility of sacral nerve stimulator placement in patients with fecal incontinence (FI) or other defecatory dysfunction who have received pelvic radiation treatment without undergoing rectal or other pelvic surgery as per standard of cancer care (radiation only cohort).

SECONDARY OBJECTIVES:

I. To evaluate the effectiveness of sacral nerve stimulation (SNS) as measured by validated questionnaires in patients with FI or LARS within both patient cohorts.

II. To evaluate pelvic floor and sphincter physiology using anorectal manometry (ARM) before and after SNS in patients with FI or LARS within both patient cohorts.

III. To assess potential impact of SNS on urinary incontinence measuring a post-void urinary bladder residual and validated urinary symptom questionnaires in both patient cohorts.

IV. To assess efficacy of SNS on long-term bowel dysfunction at 1 and 3 years post battery implantation as measured by validated questionnaires for both patient cohorts.

OUTLINE:

Patients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads.

After completion of study, patients are followed up at 1 month, 1 year, and 3 years.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Sacral Nerve Stimulation for Low Anterior Resection Syndrome or Fecal Incontinence in Patients Following a Low Anterior Resection or Proctectomy With Coloanal Anastomosis or in Patients After Pelvic Chemoradiation (RESTORE)
Actual Study Start Date : April 12, 2019
Estimated Primary Completion Date : July 31, 2025
Estimated Study Completion Date : July 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arms and Interventions
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Arm Intervention/treatment
Experimental: Supportive Care (sacral nerve stimulator)
Patients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads.
 Procedure: Explantation
Undergo lead removal
Other Name: Implant, removal of

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Device: Sacral Nerve Stimulator
Undergo sacral nerve stimulator implantation
Other Name: Sacral Neuromodulator

Device: Sacral Nerve Stimulator Battery
Undergo sacral nerve stimulator battery implantation
Other Name: Sacral Neuromodulator Battery

Procedure: Therapeutic Conventional Surgery
Undergo sacral nerve stimulator implantation


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients with Sacral nerve stimulation (SNS) success [ Time Frame: up to 2 weeks (+7) days post SNS placement ]
    Primary Outcome Measure should read only: "SNS success will be measured as a patient having the battery implanted up to 2 weeks (+7) days post SNS placement. Patients who do not have the SNS placed, for any reason other than insurance coverage issues, will count as not having a success."


Secondary Outcome Measures :
  1. Fecal Incontinence Severity Index [ Time Frame: Up to 3 years ]

    Will be reported descriptively with graphs or tabulations for categorical survey outcomes.

    • ranges from 0 to 61, a number of 30 has been shown to be reflective of severe fecal incontinence.
    • the higher the severity of the fecal incontinence,
    • no subscales

  2. Fecal Incontinence Quality of Life Scale [ Time Frame: Up to 3 years ]

    Will be reported descriptively with graphs or tabulations for categorical survey outcomes.

    • Scales range from 1-5, scale scores are the averages responses to all questions divided by the number of items (29) on the scale
    • Score of 1 indicates a lower functional status relating to quality of life

    • Subscales:

      • Lifestyle (10 items)
      • Coping/Behavior (9 items)
      • Depression/Self Perception (7 items)
      • Embarrassment (3 items)

  3. Anorectal manometry score [ Time Frame: At 1 month after completion of surgery ]

    Will be reported descriptively with graphs or tabulations for anorectal manometry measures.

    • The interpretation of the manometry findings will be documented but are not part of the determination as to if SNS is needed or not. They are not tabulated as part of a score.
    • Anal Sphincter Electromyography: Surface Electrode Anal EMG is recording by placing small electrodes peri-anally.

  4. Euroqol-5 Dimensions-5 Levels (EQ-5D-5L) [ Time Frame: Up to 3 years ]

    Will be reported descriptively with graphs or tabulations for categorical survey outcomes.

    • 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) rated on 5 levels: no problems, slight problems, moderate problems, severe problems, extreme problems
    • Additionally, participant is also asked to rate their health that day, from 0 to 100, 0 being the worst they could imagine, 100 being the best
    • This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state.
    • Scores will be assessed and compared pre and post placement to reflect general quality of life

  5. International Continence Society male Short Form [ Time Frame: Up to 3 years ]

    Will be reported descriptively with graphs or tabulations for categorical survey outcomes.

    • Higher scores indicate greater impact of individual symptoms on participant
    • 11 items assessing Voiding (5) and Incontinence (6) - renders two scores

    • Scoring:

      • 0-20 voiding symptoms subscale
      • 0-24 incontinence symptoms subscale
      • Frequency, Nocturia and QoL scores indicate impact of symptoms for the patient separately

    • Scale:

      • Occasionally = less than one third of the time
      • Sometimes = between one and two thirds of the time
      • Most of the time = more than two thirds of the time

  6. International Consultation on Incontinence Society - Female Lower Urinary Tract Symptoms [ Time Frame: Up to 3 years ]

    Will be reported descriptively with graphs or tabulations for categorical survey outcomes.

    • Overall score 0-48, (addition of all subscores)
    • Higher scores indicate greater impact of individual symptoms on participant
    • 12 items assessing Nocturia, Urgency, Bladder pain, Frequency, Hesitancy, Straining, Intermittency, Urge urinary incontinence, Frequency of urinary incontinence, Stress urinary incontinence, Unexplained urinary incontinence, Nocturnal enuresis

    • Scoring:

      • 0-16 filling symptoms subscale
      • 0-12 voiding symptoms subscale
      • 0-20 incontinence symptoms subscale
      • Bother scales are not incorporated in the overall score but indicate impact of individual symptoms for the patient

  7. Memorial Sloan Kettering Cancer Center Bowel Function Questionnaire (BFQ) (restorative surgery cohort) [ Time Frame: Up to 3 years ]

    Will be reported descriptively with graphs or tabulations for categorical survey outcomes.

    • five frequency options range from never to always (except for one question asking about the number of bowel movements per 24 hours)
    • 18 questions (14 within subscales and with four single items do not belong to a subscale). A global score can be calculated as the sum of the subscale scores, and a total score can be calculated by adding all the item scores (subscale plus single item scores). A higher score represents better bowel function.

    • Three subscales

      • frequency, 6 items
      • diet, 4 items
      • urgency/soilage, 4 items

  8. Low anterior resection syndrome score BFQ [ Time Frame: Up to 3 years ]

    Will be reported descriptively with graphs or tabulations for categorical survey outcomes.

    • range 0-42 points: ("no LARS": 0-20), ("minor LARS": 21-29), ("major LARS": 30-42). Major LARS requires treatment

    • 5 issues graded,

      • Incontinence for flatus (0: no, never; 4: yes, less than once/week; 7: yes, at least once/week)
      • Incontinence for liquid stool (0: no, never; 3: yes, less than once/week; 3: yes, at least once/week)
      • Frequency (4: >7x/day (24 hrs); 2: 4-7x/day, 0: 1-3x/day; 5: less than 1x/day)
      • Clustering (0: no, never; 9: yes - less than once/week; 11: yes, at least once/week)
      • Urgency (0: no, never; 11: yes - less than once/week; 16: yes, at least once/week)

  9. Cleveland Clinic Incontinence Score (radiation cohort) [ Time Frame: Up to 3 years ]

    Will be reported descriptively with graphs or tabulations for categorical survey outcomes.

    • 5 questions. The frequency with which each type of incontinence occurs is rated on a scale from 0 (never) to 4 (always or to 1/day). The sum of the frequencies is added for a total score that can range from 0 - 20, with higher scores indicating higher levels of incontinence.


  10. Impact of SNS on bowel dysfunction [ Time Frame: Up to 30 days (visit 2) ]
    Will be measured using bowel diaries.

  11. Impact of SNS on urinary incontinence of the Bladder Diaries [ Time Frame: Up to 30 days (visit 2) ]
    Will be measured using bladder diaries and a post-void urinary bladder residual and validated urinary symptom questionnaire.

  12. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29 [ Time Frame: Up to 3 years ]

    Will be reported descriptively with graphs or tabulations for categorical survey outcomes.

    • has 5 functional and 18 symptom scales.
    • Contains 4 subscales (urinary frequency (UF), blood and mucus in stool (BMS), stool frequency (SF), and body image (BI)) and 19 single items (urinary incontinence, dysuria, abdominal pain, buttock pain, bloating, dry mouth, hair loss, taste, anxiety, weight, flatulence, fecal incontinence, sore skin, embarrassment, stoma care problems, sexual interest (men), impotence, sexual interest (women), and dyspareunia).
    • Scores can be linearly transformed to provide a score from 0 to 100.
    • Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cohort 1: Patients with pathologically proven diagnosis of primary rectal cancer
  • Cohort 1: Patients who have previously undergone surgical resection and anastomosis (restorative) with curative intent treatment with or without chemoradiation
  • Cohort 1: Patients with T1 and T2 pathologic stage patients treated with restorative surgical resection without radiation
  • Cohort 1: Patients with locally advanced rectal adenocarcinoma (T3 and T4 or lymph node positive) treated with radiation and restorative surgery
  • Cohort 1: Patients with self-reported FI or LARS
  • Cohort 1: Patients must be able to speak and understand English
  • Cohort 1: Patients must be willing to and able to sign an approved informed consent document
  • Cohort 1: Patients must be >= 24 months post-resection of rectal cancer
  • Cohort 1: Patients must have failed prior conservative measures such as Metamucil and motility medications and already been assessed and treated in a pelvic floor rehabilitation program (biofeedback) designed to treat FI and LARS, and continue to experience significant defecatory dysfunction, allowable per principal investigator (PI) discretion
  • Cohort 1: Patients must be willing and able to complete Patient Reported Outcomes Questionnaires for before device placement, during the testing phase following lead placement, and after implantation of the battery
  • Cohort 1: Patients must be willing and able to undergo elective ARM testing to objectively measure pelvic floor function
  • Cohort 1: Patients who have an average resting tone < 40 mmHg (normal > 40 mmHg) and maximal tolerance < 200 milliliters (normal 200-300 milliliters) as measured by ARM
  • Cohort 2: Patients with pathologically proven malignancy of the pelvis, other than rectal cancer (e.g. prostate, bladder, anus, vagina, vulva, cervix, uterus, or ovary)
  • Cohort 2: Patients treated with standard of care radiation therapies without surgical resection
  • Cohort 2: Patients with self-reported FI or other defecatory dysfunction
  • Cohort 2: Patients must be able to speak and understand English
  • Cohort 2: Patients must be willing to and able to sign an approved informed consent document
  • Cohort 2: Patients must be >= 18 months post-pelvic chemoradiation
  • Cohort 2: Patients must have already been assessed and treated in a pelvic floor rehabilitation program design to treat FI or other defecatory dysfunction and continue to experience significant defecatory dysfunction
  • Cohort 2: Patients must be willing and able to complete Patient Reported Outcomes (PROs) and bowel and bladder diaries (Medtronic) at multiple times during the study
  • Cohort 2: Patients must be willing and able to undergo elective ARM testing to measure pelvic floor function
  • Cohort 2: Patients who have an average resting tone < 40 mmHg (normal > 40 mmHg) and maximal tolerance < 200 milliliters (normal 200-300 milliliters) as measured by ARM

Exclusion Criteria:

  • Cohort 1: Patients with co-morbid illnesses or concurrent disease, which in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Cohort 1: Any diverting bowel ostomy at the time of consent to this study
  • Cohort 1: Patients with an absolute neutrophil count (ANC) < 1.7 within 30 days of consent
  • Cohort 1: Patients with an international normalized rate (INR) > 1.3 within 30 days of consent
  • Cohort 1: Patients with a platelet count < 50 K within 30 days of consent
  • Cohort 1: Patients currently being treated with chemotherapy or within preceding 30 days at the time consent
  • Cohort 1: Patients previously treated with a SNS for urinary or FI
  • Cohort 1: Patients who were documented to have an anastomotic leak following their restorative surgical resection
  • Cohort 1: Patients with an Eastern Cooperative Oncology Group (ECOG) performance status > 2 at the time of consent
  • Cohort 1: Patients with an active infection requiring systemic therapy at the time of consent
  • Cohort 1: Patients with a significant history of uncontrolled cardiac disease including, but not limited to hypertension, unstable angina, myocardial infarction within the last 4 months, and uncontrolled congestive heart failure
  • Cohort 2: Co-morbid illnesses or other concurrent disease, which in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Cohort 2: Patients with an ANC < 1.7 within 30 days of consent
  • Cohort 2: Patients with an INR > 1.3 within 30 days of consent
  • Cohort 2: Patients with a platelet count < 50 K, within 30 days of consent
  • Cohort 2: Patients currently being treated with chemotherapy or within the preceding 30 days at the time of consent
  • Cohort 2: Patients previously treated with a sacral nerve stimulator for urinary or fecal incontinence
  • Cohort 2: Patients with an ECOG performance status > 2 at the time of consent
  • Cohort 2: Patients with an active infection requiring systemic therapy at the time of consent
  • Cohort 2: Patients with a significant history of uncontrolled cardiac disease including, but not limited to hypertension, unstable angina, myocardial infarction within the last 4 months, and uncontrolled congestive heart failure
  • Cohort 2: Patients with an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study
  • Cohort 2: Patients who are human immunodeficiency virus (HIV) positive (+) or have hepatitis B or C remain eligible, however, HIV+ patients must have a CD4 T cell count > 200 cells per microliter
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066894


Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Craig A. Messick    713-792-6940    cmessick@mdanderson.org   
Principal Investigator: Craig A. Messick         
MD Anderson in Sugar Land Recruiting
Sugar Land, Texas, United States, 77478
Contact: Craig A. Messick    713-792-6940    cmessick@mdanderson.org2016-0754   
Principal Investigator: Craig A. Messick         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Craig A Messick M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04066894    
Other Study ID Numbers: 2016-0754
NCI-2019-02649 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0754 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Neoplasms
Rectal Neoplasms
Ovarian Neoplasms
Uterine Cervical Neoplasms
Urinary Bladder Neoplasms
Prostatic Neoplasms
Uterine Neoplasms
Vulvar Neoplasms
Pelvic Neoplasms
Vaginal Neoplasms
Anus Neoplasms
Fecal Incontinence
Syndrome
Disease
Pathologic Processes
 Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases