Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-03-08 @ 11:00 PM
Study NCT ID:
NCT07041151
Status:
RECRUITING
Last Update Posted:
2025-08-15
First Post:
2025-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self-discontinuation of Urinary Catheters in a Rural Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized in a 1:1 ratio to either at-home foley catheter removal with a passive void trial or in-office catheter removal with a backfill void trial. Each participant will receive one intervention only and will be followed through postoperative recovery.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2025-06-18', 'studyFirstSubmitQcDate': '2025-06-18', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Satisfaction with Void Trial Process', 'timeFrame': '2 weeks postoperatively', 'description': 'Measured using a 0-100 mm visual analog scale (VAS) administered at the 2-week follow-up visit.'}], 'secondaryOutcomes': [{'measure': 'Postoperative Urinary Retention', 'timeFrame': 'within 72 hours postoperatively', 'description': 'Defined as inability to void ≥200 mL within 30 minutes after backfill (in-office) or failure to void minimum volume within 6 hours post-catheter removal (at-home).'}, {'measure': 'Urinary tract infection', 'timeFrame': 'Within 30 days postoperatively', 'description': 'Defined by positive urine culture (≥100,000 CFU/mL of uropathogen) and/or clinical diagnosis documented in the chart.'}, {'measure': 'Adverse Events Related to Foley Catheter Removal or Void Trial', 'timeFrame': 'up to 30 days postoperatively', 'description': 'Includes catheter reinsertion, pain, bleeding, ED visits, unplanned clinic visits, or other provider-documented complications.'}, {'measure': 'Healthcare Resource Utilization', 'timeFrame': 'up to 30 days postoperatively', 'description': 'Includes the number of MyDH messages, telephone encounters, and unplanned clinic or emergency department visits related to the void trial process, as documented in the electronic medical record.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post-operative urinary retention', 'Self-removal of foley catheter', 'Self-discontinuation of foley catheter', 'Post-operative void trial', 'Urogynecology', 'Pelvic surgery', 'Catheter management'], 'conditions': ['Post-Operative Urinary Retention']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to understand patient satisfaction with two different ways of managing difficulty urinating after gynecologic surgery with a focus on those patients who receive care in a rural area.\n\nOne common practice is to have an "office catheter removal." This means, if a patient has trouble urinating after surgery and goes home with a foley catheter, they usually have to come back to the clinic within 2-3 days to have the catheter removed and to do a test to see if they can urinate on their own. For some patients, coming back to the clinic so soon after surgery can be difficult, especially for those patients who live far away or are dependent on others for getting to appointments.\n\nA second, less common, practice is to have patients remove their own catheter at home, or "self-removal of urinary (Foley) catheter." With self-removal, patients remove their Foley catheter at home, and confirm that they are urinating normally. This approach has been shown to be safe, with similar patient satisfactions, and success, but those studies did not take into account situations where patients may live a rural area and/or travel a long distance to the medical center to receive care.\n\nThis study is comparing the in-office removal with self-removal. The goal is to find out which option patients prefer, how convenient each approach is, and how well they work. The main goal of this study is to understand patient satisfaction and improve care after surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults aged 18 years or older\n2. Undergoing gynecologic surgery with planned postoperative trial of void to confirm normal voiding prior to discharge home\n3. Willing and able to provide informed consent\n4. English-speaking\n5. Willing to comply with study procedures, including follow-up phone calls and surveys\n\nExclusion Criteria:\n\n1. Known urinary tract abnormalities (e.g., urethral strictures, neurogenic bladder) that may affect voiding.\n2. Diagnosis of voiding dysfunction prior to surgery with need to self-catheterize.\n3. Perioperative complication that necessitates indwelling catheter for a specific duration of time.\n4. Joint surgeries that would affect ability to comply with study methods (e.g. that necessitates longer inpatient admission or reduces mobility beyond that normal for postop patients after gynecologic surgery)\n5. Presence of significant cognitive or physical impairments that limit the ability to comply with study procedures.'}, 'identificationModule': {'nctId': 'NCT07041151', 'briefTitle': 'Self-discontinuation of Urinary Catheters in a Rural Population', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Self-discontinuation of Urinary Catheters in Patients With Urinary Retention Following Gynecologic Surgery in a Rural Population', 'orgStudyIdInfo': {'id': 'STUDY02002854'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'At-home passive void trial', 'description': 'Participants will be instructed to remove their foley catheter at home 48-72 hours postoperatively. After removal, they will perform a passive void trial and will be monitored for successful voiding within a designated time frame. Instructions will be provided, and participants will be advised to contact the clinic if unable to void.', 'interventionNames': ['Other: At-home Foley Catheter Self-Removal with Passive Void Trial']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'In-office backfill void trial', 'description': 'Participants will return to the clinic 48-72 hours postoperatively for standard foley catheter removal and a backfill void trial. The bladder will be filled with 300 mL of sterile water, and voiding will be assessed in clinic per institutional protocol.', 'interventionNames': ['Other: In-Office Foley Catheter Removal and Backfill Void Trial']}], 'interventions': [{'name': 'At-home Foley Catheter Self-Removal with Passive Void Trial', 'type': 'OTHER', 'description': 'Participants will remove their foley catheter at home and perform a passive void trial. They will be instructed to drink fluids and attempt to void within a designated time frame. Instructions and support will be provided to ensure safety and follow-up, including clinic contact if voiding is unsuccessful.', 'armGroupLabels': ['At-home passive void trial']}, {'name': 'In-Office Foley Catheter Removal and Backfill Void Trial', 'type': 'OTHER', 'description': 'Participants will return to clinic for removal of their foley catheter and undergo a backfill void trial. Standard protocols for instillation and assessment of urinary retention will be followed.', 'armGroupLabels': ['In-office backfill void trial']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03766', 'city': 'Lebanon', 'state': 'New Hampshire', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ekaterina Grebenyuk, MD', 'role': 'CONTACT', 'email': 'ekaterina.a.grebenyuk@hitchcock.org', 'phone': '603-653-9300'}], 'facility': 'Dartmouth Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '03104', 'city': 'Manchester', 'state': 'New Hampshire', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ekaterina Grebenyuk, MD', 'role': 'CONTACT', 'email': 'ekaterina.a.grebenyuk@hitchcock.org', 'phone': '603-653-9300'}], 'facility': 'Dartmouth Manchester Ambulatory Surgery Center', 'geoPoint': {'lat': 42.99564, 'lon': -71.45479}}], 'centralContacts': [{'name': 'Ekaterina Grebenyuk, MD', 'role': 'CONTACT', 'email': 'ekaterina.a.grebenyuk@hitchcock.org', 'phone': '603-653-9300'}, {'name': 'Anne Cooper, MD, MS', 'role': 'CONTACT', 'phone': '603-653-9300'}], 'overallOfficials': [{'name': 'Ekaterina Grebenyuk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth-Hitchcock Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is a single-center, investigator-initiated study. There are no plans to share individual participant data at this time.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ekaterina.A.Grebenyuk', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}