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Sacral Nerve Stimulator for Colorectal Cancer

Phase 2
Waitlist Available
Led By Craig A Messick, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial looks at whether sacral nerve stimulation can help people with rectal cancer who have problems controlling their stool.

Eligible Conditions
  • Colorectal Cancer
  • Anal Cancer
  • Anterior Resection Syndrome
  • Cervical Cancer
  • Bladder Cancer
  • Ovarian Cancer
  • Pelvic Cancer
  • Prostate Cancer
  • Uterine Cancer
  • Vulvar Cancer
  • Vaginal Neoplasms

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sacral Nerve Stimulation (SNS) Success
Secondary outcome measures
Cleveland Clinic Incontinence Score
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29
Euroqol-5 Dimensions-5 Levels (EQ-5D-5L)
+7 more

Side effects data

From 2021 Phase 3 trial • 902 Patients • NCT04225260
7%
Injection site Pain
7%
Injection site bruising
6%
Headache
5%
COVID-19
2%
Aspartate aminotransferase increased
2%
Hypertension
2%
Alanine aminotransferase increased
2%
Urinary Tract Infection
2%
Upper respiratory tract infection
1%
Sinusitis
1%
Gamma-glutamyltransferase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
QM1114-DP in the LCL and the GL Areas

Trial Design

1Treatment groups
Experimental Treatment
Group I: Supportive Care (sacral nerve stimulator)Experimental Treatment6 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
Explantation
2010
N/A
~200

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,150 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,778 Total Patients Enrolled
Craig A Messick, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
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
2019. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04066894.
~0 spots leftby Apr 2025
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