Clinical trial · Interventional
Use of Pedometer Following Radical Cystectomy
Does the Use of a Post-Operative Pedometer Affect Rate of Return of Bowel Function and Narcotic Use Following Radical Cystectomy
NCT04305730CI-TRIAL-00050072unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a study to evaluate whether use of a pedometer following radical cystectomy decreases post-operative narcotic use and time to return of bowel function.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Ileus | — | UNRESOLVED | — |
| Narcotic Use | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard of care | Behavioral | — | UNRESOLVED |
| Use of a pedometer following surgery | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pedometer Group
- description
- This group will be given a pedometer following radical cystectomy. Subjects in the experimental group will have a graduated step-count goal as follows: POD 0-2: 1,000/day. POD 3-6: 2,000/day. POD 7-9: 3,000/day. POD 10-14: 4,000/day. POD 14-21: 5,000
- interventionNames
- Behavioral: Use of a pedometer following surgery
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- This is the control group. Following radical cystectomy subjects in the control group will receive standard of care, which includes counseling regarding the importance of ambulation following surgery.
- interventionNames
- Behavioral: Standard of care
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: This study will include men and women age18-75 undergoing radical cystectomy for bladder cancer at Virginia Mason Medical Center. This includes both open and robot-assisted radical cystectomy, and all types of urinary diversion will be included in the trial. Subjects both with and without neo-adjuvant chemotherapy will be included in the study. Exclusion Criteria: * Long-term opioid use, defined by CDC as use of opioids on most days for \>3 months * History of inflammatory bowel disease * Prior abdominopelvic radiation * Travel to Europe during study period * Concurrent surgery during radical cystectomy * Inability to ambulate * Gastroparesis or other baseline bowel dysmotility issues * Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.