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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

United States1 site
  • Yale University

    New Haven, Connecticut, 06510

Other trials in United States

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.

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 groups in NCT03373773
Study groupRoleWhat they receive
Home RemovalActive comparatorPatients 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 RemovalActive comparatorPatients 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted14 Dec 2017
  2. Study start12 Mar 2018
  3. Primary completion19 Aug 2021
  4. Study completion19 Aug 2021

Resources

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)
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

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.

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