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

Summary

This phase II 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.

Conditions

• 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 Carcinoma

Interventions

PROCEDURE

Explantation

Undergo lead removal

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

DEVICE

Sacral Nerve Stimulator

Undergo sacral nerve stimulator implantation

DEVICE

Sacral Nerve Stimulator Battery

Undergo sacral nerve stimulator battery implantation

PROCEDURE

Therapeutic Conventional Surgery

Undergo sacral nerve stimulator implantation

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Craig A Messick, MD · M.D. Anderson Cancer Center

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-12

Primary Completion

2022-09-01

Completion

2022-09-01

FDA Device

Yes

Countries

• United States

Study Locations