Voiding DisordersNCT03373773
Home vs. Office Foley Catheter Removal in Women With Voiding Difficulty Following Pelvic Reconstructive Surgery
A study testing Foley catheter removal in people with Voiding Disorders, run by Yale University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Voiding Disorders
- What is being tested?
- Foley catheter removal
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2018to 19 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with post-operative voiding difficulty requiring catheterization after pelvic reconstructive surgery or surgery for urinary incontinency.
Who cannot join
- A Pelvic Reconstructive Surgery/Urogynecology fellow or attending physician may deem patients ineligible based on patients post-operative voiding trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home vs. Office Foley Catheter Removal in Women With Voiding Difficulty Following Pelvic Reconstructive Surgery: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Voiding Disorders
- Being tested
- Foley catheter removal
- Keywords
- pelvic reconstructive surgery, foley catheter, Foley removal, Urogynecology, Urinary Retention, Gynecologic surgery
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foley catheter removalProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Home Removal | Active comparator | 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. Receives: Procedure: Foley catheter removal |
| Office Removal | Active comparator | 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. Receives: Procedure: Foley catheter removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start12 Mar 2018
- Primary completion19 Aug 2021
- Study completion19 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Voiding DisordersStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oz Harmanli, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373773
- Sponsor's protocol ID
- 2000030019
- Other IDs
- 2000022371
- Status last verified
- Aug 2022
- First submitted
- 11 Dec 2017
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Popiel P, Getaneh F, Yeh J, Rickey L, Bercik R, Harmanli O. Voided Volume for Assessment of Bladder Emptying After Female Pelvic Floor Surgery: A Randomized Controlled Trial. Urogynecology (Phila). 2022 Dec 1;28(12):811-818. doi: 10.1097/SPV.0000000000001230. Epub 2022 Jun 22.
PubMed 36409638
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home vs. Office Foley Catheter Removal in Women With Voiding Difficulty Following Pelvic Reconstructive Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03373773
- Acronym / sponsor ID
- 2000030019
- Conditions
- Voiding Disorders
- Keywords
- pelvic reconstructive surgery, foley catheter, Foley removal, Urogynecology, Urinary Retention, Gynecologic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 19 Aug 2021 (actual)
- Study completion
- 19 Aug 2021 (actual)
- First posted
- 14 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Removal | Active comparator | Procedure: Foley catheter removalPatients 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. |
| Office Removal | Active comparator | Procedure: Foley catheter removalPatients 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women with post-operative voiding difficulty requiring catheterization after pelvic reconstructive surgery or surgery for urinary incontinency.
Key exclusion criteria (1 listed)
- A Pelvic Reconstructive Surgery/Urogynecology fellow or attending physician may deem patients ineligible based on patients post-operative voiding trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foley catheter removalAfter 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. | Procedure or surgery | Home Removal, Office Removal |
Primary outcome
Patient Satisfaction
Time frame: Up to 4 weeks
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.
4 secondary outcomes
Removal Method Negative Emotions
Time frame: Up to 4 weeks
Removal Method Recommendation
Time frame: Up to 4 weeks
Removal Method Convenience
Time frame: Up to 4 weeks
Removal Method Preference
Time frame: Up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- Derived from this study: PubMed 36409638Popiel P, Getaneh F, Yeh J, Rickey L, Bercik R, Harmanli O. Voided Volume for Assessment of Bladder Emptying After Female Pelvic Floor Surgery: A Randomized Controlled Trial. Urogynecology (Phila). 2022 Dec 1;28(12):811-818. doi: 10.1097/SPV.0000000000001230. Epub 2022 Jun 22.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oz Harmanli principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foley catheter removal in people with Voiding Disorders, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: Up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03373773, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2022.