An interventional study of Foley catheter removal in Voiding Disorders, sponsored by Yale University. Completed at 1 site in United States. Open to female participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-08-29.
Sponsored by Yale University · Not applicable, Interventional, and Supportive care
Among 98 studies in Urinary Retention with a site in United States — 13 open to participants now, 18 under way, 1 of them phase 3. Urinary Retention · United States.
Among the 98 studies in Urinary Retention with a site in United States, this one is the 44th largest by enrollment of the 81 interventional ones, is one of 8 that started in 2018, is one of 53 with no phase, and was the 46th registered.
241 studies on the registry are indexed under Urinary Retention; 44 are open to participants now.
This study's enrollment of 78 is below the median of 90 across 187 interventional studies indexed under Urinary Retention.
Browse Urinary Retention studies →13 of the 98 studies in Urinary Retention with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 31 Urinary Retention studies recruiting now, 23 (74%) set no upper age limit and 5 (16%) stop at 75 or younger; 1 take children under 18; 7 take healthy volunteers.
This study: 18 Years to 85 Years · female · no healthy volunteers.
The full table on the hub →98 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 8 started in 2018.
Median enrollment 88 across the 81 interventional studies, 90 across the 17 observational. Of the 69 that completed or were terminated, 35 (51%) have results posted.
18 of 98 have an industry lead sponsor. The 10 most frequent:
Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
Yale University has 2 studies filed under Urinary Retention — fewer than ten, so there is no comparison to draw.
8 of the studies in Urinary Retention with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06179654The Cleveland ClinicPreoperative Pelvic Floor Physical Therapy to Minimize Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate | 2026-11-30 |
| NCT04597372Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Impact of Tamsulosin on Post-Operative Urinary Retention Following Pelvic Reconstructive Surgery | 2026-12 |
| NCT05200923MedtronicNeuroPelvic Health Electrically Evoked Recording (PEER) 2 Study | 2026-12-18 |
| NCT07174349Mayo ClinicUroselective Alpha-1-Antagonist to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery | 2027-01-31 |
| NCT06918067Wake Forest University Health SciencesComparison of Urinary Flow Study | 2027-03 |
Among the 98 studies in Urinary Retention with a site in United States, from their registry updates:
The purpose of this study is to evaluate the patient satisfaction with voiding assessment remotely after removal of Foley catheter at home by the patient or her caregiver compared to removal at the office by a healthcare provider in patients who have been diagnosed to have voiding difficulty after pelvic reconstructive surgery.
While in the hospital, all women who undergo surgery for pelvic organ prolapse and/or urinary incontinence will have a voiding trial to evaluate whether their bladder is working as it should. A voiding trial is when you are asked to urinate when you feel the desire to do so, sometimes, a physician may fill your bladder with water prior to removing the Foley catheter. This allows the physician to know exactly how much is left in your bladder. This evaluation will occur in the recovery room for subjects who have a same-day procedure. Those who are admitted to the hospital will have the voiding trial before their discharge typically on postoperative day 1. Those who fail the voiding trial will be diagnosed with urinary retention (bladder not working as well as we expect) and will be discharged home with a Foley catheter. If you agree to participate you will be randomly assigned to one of two groups: Subjects in the one group will remove their indwelling Foley catheter at home and will have a voiding assessment done over the telephone based on their self-reported force of urinary stream. The other group will follow up in the Uro/Gynecology office for Foley catheter removal and voiding trial. Which group you are assigned to will be random. You have an equal chance to be assigned to either group. It is important to note that outside of the study, physicians choose to manage patients one of these two ways. Removal of the Foley catheter at home is not experimental, and often done in these situations.
Both groups of women will be given instructions on urinary catheter and bag (where the urine drains into) management. Prior to discharge, every subject from the home removal group as well as their significant other/caregiver/family member if applicable will receive a standardized education session and written and illustrated instructions on Foley catheter removal. This teaching will be done by an experienced and qualified nurse. You will be provided with the syringe for catheter removal, urine collection pan, and a diary to record their voiding quality and quantity. Both groups of women will have the catheter removal in 2 days. This will have to be delayed up to 4 days due to weekends if the procedure is performed on a Thursday or Friday.
In the home removal group, you and your significant other/caregiver/family member will be instructed to remove the Foley catheter at the pre-set date prior to 8 am. The research nurse or Uro/Gynecology (uro/Gyn) office nurse will contact contact 4 hours after removal. Voiding function will be evaluated by your self reported Force of Stream (FOS). This means the force that urine is expelled from your body compared to normal. A report of FOS of at least 5 on a 0-10 has been shown to be a safe and effective method of assessing voiding function. Additionally, volume of each void will be measured by you and reported to the research nurse and/or the UroGyn office nurse. If there is evidence of voiding difficulty as indicated by a FOS below 5/10, the research and/or UroGyn nurse will instruct you to follow up in the office immediately for clean intermittent self-catheterization (CISC) teaching. This means inserting a small, thin plastic tube in your urethra (opening of the body where urine is expelled). If your voiding pattern qualifies as adequate, you will not require an office visit for voiding assessment. However, you will be instructed to contact the office if you feel full after voiding, are voiding less than 2 ounces or 50 mL each time and more often than every 30 minutes, or feel pressure and discomfort in their lower abdomen.
Women in the other group will return to the office in 2-4 days and will undergo a voiding trial via retrograde fill with 10 ounces (300 mL) of normal saline or until your bladder capacity is reached. This means that a catheter will be inserted in your urethra and normal saline will be put in your bladder via a large syringe that acts as a funnel. You would be considered to have failed the voiding trial and be taught clean intermittent self-catheterization if you do not void 5 ounces (150 mL) within an hour or you become too uncomfortable with the bladder fullness, and your postvoid residual volume is greater than 150 mL. The residual volume is determined by a portable ultrasound like machine via an external probe which is scanned over your lower pelvic area.
At the routine 2 - 4 week post-operative visit, both groups will receive a 5 question survey asking about your experience with removal of the Foley catheter.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients will be randomly allocated to two groups: subjects in one group will remove their indwelling Foley catheter at home and will have voiding assessment remotely based on their voiding characteristics (a Force of Stream of \>5/10 indicates that the patient has adequate bladder function), and the other group will follow up in the office for Foley catheter removal and voiding trial. Subjects in this arm will remove the Foley catheter at home.
Procedure: Foley catheter removal
Patients will be randomly allocated to two groups: subjects in one group will remove their indwelling Foley catheter at home and will have voiding assessment remotely based on their voiding characteristics (a Force of Stream of \>5/10 indicates that the patient has adequate bladder function), and the other group will follow up in the office for Foley catheter removal and voiding trial. Subjects in this arm will remove the Foley catheter in a medical office.
Procedure: Foley catheter removal
After reinsertion of the Foley catheter, both groups of women will be given instructions on urinary catheter and bag management, this will be done by an RN as per standard protocol. Prior to discharge, every subject from the home removal group as well as their significant other/caregiver/family member will receive a standardized education session and written and illustrated instructions on Foley catheter removal from RN, per standard protocol. They will be provided with the syringe for catheter removal, urine collection pan, and a diary to record their voiding quality and quantity. Both groups of women will have the catheter removal in 2 days.
Patient Satisfaction
At the routine 2-4 week post-operative visit, patients will be given an internally developed 5 item visual analogue scale regarding their experience with the Foley-catheter removal. The item used as the primary outcome measure will ask "How satisfied were you with the overall removal process of the Foley catheter?" Lower scores indicate less satisfaction, higher scores higher satisfaction.
Time frame: Up to 4 weeks
Removal Method Negative Emotions
At the routine 2-4 week post-operative visit, patients will be given an internally developed 5 item visual analogue scale regarding their experience with the Foley-catheter removal. This item used asks "Did you experience any negative emotions during the removal process (e.g. fear, anxiety ect.)?" Lower scores indicate greater negative emotions, higher scores indicate fewer negative emotions.
Time frame: Up to 4 weeks
Removal Method Recommendation
At the routine 2-4 week post-operative visit, patients will be given an internally developed 5 item visual analogue scale regarding their experience with the Foley-catheter removal. This item used asks "How likely would you be to recommend your method of Foley catheter removal to a friend/family member, if they were in the same situation?" Lower scores indicate less likely to recommend, higher scores indicate more likely to recommend.
Time frame: Up to 4 weeks
Removal Method Convenience
At the routine 2-4 week post-operative visit, patients will be given an internally developed 5 item visual analogue scale regarding their experience with the Foley-catheter removal. This item used asks "How convenient was the process of Foley catheter removal (e.g. time, ease ect.)?" Lower scores indicate less convenient, higher scores indicate more convenient.
Time frame: Up to 4 weeks
Removal Method Preference
At the routine 2-4 week post-operative visit, patients will be given an internally developed 5 item visual analogue scale regarding their experience with the Foley-catheter removal. This item used asks "Where would you prefer your Foley catheter removed?" Lower scores indicate preference for office removal, higher scores indicate preference for home removal.
Time frame: Up to 4 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Mar 2018 to primary completion in Aug 2021, 41 months.
Of 70 non-industry interventional studies with no phase under Urinary Retention, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's 41 months is above that.
Counting every sponsor, half of 82 studies reached it within 18 months; a quarter within 9 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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