Voiding DysfunctionNCT05820139
Evaluating the Optimal Volume Voided for Passage of a Backfill-Assisted Voiding Trial Following Urogynecologic Surgery
A study testing Test Group in people with Voiding Dysfunction, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Urinary retention can lead to bladder over-distention, ischemia, and long-term voiding dysfunction, and early identification of urinary retention can help prevent these adverse events Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Voiding Dysfunction
- What is being tested?
- Test Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2023to 26 Feb 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nonpregnant women >18yo undergoing pelvic organ prolapse or urinary incontinence surgery
Who cannot join
- Patients undergoing fistula repair or sacral neuromodulation
- Voiding dysfunction preoperatively that requires intermittent self-catheterization
- Intraoperative bladder injury
- Pregnancy
- Preoperative UTI (culture proven within 7 days prior to surgery)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: A Randomized Controlled Single-Blinded Study Evaluating the Optimal Volume Voided for Passage of a Backfill-Assisted Voiding Trial Following Urogynecologic Surgery
Urinary retention can lead to bladder over-distention, ischemia, and long-term voiding dysfunction, and early identification of urinary retention can help prevent these adverse events
Read the detailed description
Postoperative voiding trials (VT) can identify as well as prevent postoperative urinary retention. Voiding trial protocols vary by provider and healthcare facilities/institutions as there is no consensus on how to prevent postoperative urinary retention optimally. Identification of an optimal VT could not only help decrease adverse events associated with urinary retention but also decrease postoperative catheter-associated urinary tract infection (CAUTI) rates, unplanned hospital or clinic visits, and decrease patient discomfort while increasing patient satisfaction.
- Conditions
- Voiding Dysfunction
- Being tested
- Control Group, Test Group
- Keywords
- Urinary Tract Infections, overactive bladder, pelvic organ prolapse surgery, urinary incontinence surgery
- Medical subject headings
- Urinary Tract Infections, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupProcedure or surgery
Also called backfill-assisted voiding trial
Patients will be randomized to a 200mL (control group)
Test GroupProcedure or surgery
Also called backfill-assisted voiding trial
Patients will be randomized to a cut-off of 150mL (test group)
| Study group | Role | What they receive |
|---|---|---|
| control group (voids 2/3 of the volume backfilled) | Other | control group Receives: Procedure: Control Group |
| test group (voids ½ of the total volume backfilled) | Active comparator | test group) Receives: Procedure: Test Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in acute voiding dysfunction between a backfill assisted voiding trial
difference in acute voiding dysfunction between a backfill assisted voiding trial with a volume voided cutoff of 150mL vs. 200mL for passage of VT - Acute voiding dysfunction is defined as a failed voiding trial requiring discharge home with a catheter, as well as voiding dysfunction occurring at a later time that results in an emergency department/urgent care/clinic visit requiring either an indwelling catheter or clean intermittent catheterization (CIC)
Measured: Week 6
Secondary outcomes (5)
proportion of patients develops postoperative UTIs
UTI diagnosed by symptomatology alone or urinalysis (UA) + culture proven within one week (7 days) of catheter removal
Measured: Day 7
proportion of patients developing overactive bladder symptoms
Sudden urge to urinate that is difficult to hold, with leakage of urine (even if you just voided recently), Frequent urination (>8 times/day), or waking up at night to urinate (2 or more times/night)
Measured: Week 6
proportion of patients developing bladder pain or pressure
Bladder pain (pain or discomfort in the lower abdomen when your bladder is full) or bladder pressure (continuous feeling of pressure, not relieved by urination)
Measured: Week 6
proportion of patients requiring repeat outpatient voiding trials
proportion of patients requiring repeat outpatient voiding trials
Measured: Week 6
average number of days postoperatively, that require catheterization
average number of days postoperatively, that require catheterization
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start11 Jul 2023
- Primary completion26 Feb 2024
- Study completion26 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voiding DysfunctionStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be recruited at an Urogynecology office either at the pre-operative visit or on the day of surgery
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Lovejoy, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820139
- Sponsor's protocol ID
- IRB00091698
- Status last verified
- Mar 2024
- First submitted
- 7 Apr 2023
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Single-Blinded Study Evaluating the Optimal Volume Voided for Passage of a Backfill-Assisted Voiding Trial Following Urogynecologic Surgery
- ClinicalTrials.gov ID
- NCT05820139
- Acronym / sponsor ID
- IRB00091698
- Conditions
- Voiding Dysfunction
- Keywords
- Urinary Tract Infections, overactive bladder, pelvic organ prolapse surgery, urinary incontinence surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 19 Apr 2023 (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.
Urinary retention can lead to bladder over-distention, ischemia, and long-term voiding dysfunction, and early identification of urinary retention can help prevent these adverse events
Detailed description
Postoperative voiding trials (VT) can identify as well as prevent postoperative urinary retention. Voiding trial protocols vary by provider and healthcare facilities/institutions as there is no consensus on how to prevent postoperative urinary retention optimally. Identification of an optimal VT could not only help decrease adverse events associated with urinary retention but also decrease postoperative catheter-associated urinary tract infection (CAUTI) rates, unplanned hospital or clinic visits, and decrease patient discomfort while increasing patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be recruited at an Urogynecology office either at the pre-operative visit or on the day of surgery
| Arm | Type | Receives |
|---|---|---|
| control group (voids 2/3 of the volume backfilled) | Other | Procedure: Control Groupcontrol group |
| test group (voids ½ of the total volume backfilled) | Active comparator | Procedure: Test Grouptest group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Nonpregnant women >18yo undergoing pelvic organ prolapse or urinary incontinence surgery
Key exclusion criteria (5 listed)
- Patients undergoing fistula repair or sacral neuromodulation
- Voiding dysfunction preoperatively that requires intermittent self-catheterization
- Intraoperative bladder injury
- Pregnancy
- Preoperative UTI (culture proven within 7 days prior to surgery)
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 |
|---|---|---|
| Control GroupAlso: backfill-assisted voiding trialPatients will be randomized to a 200mL (control group) | Procedure or surgery | control group (voids 2/3 of the volume backfilled) |
| Test GroupAlso: backfill-assisted voiding trialPatients will be randomized to a cut-off of 150mL (test group) | Procedure or surgery | test group (voids ½ of the total volume backfilled) |
Primary outcome
difference in acute voiding dysfunction between a backfill assisted voiding trial
Time frame: Week 6
difference in acute voiding dysfunction between a backfill assisted voiding trial with a volume voided cutoff of 150mL vs. 200mL for passage of VT - Acute voiding dysfunction is defined as a failed voiding trial requiring discharge home with a catheter, as well as voiding dysfunction occurring at a later time that results in an emergency department/urgent care/clinic visit requiring either an indwelling catheter or clean intermittent catheterization (CIC)
5 secondary outcomes
proportion of patients develops postoperative UTIs
Time frame: Day 7
proportion of patients developing overactive bladder symptoms
Time frame: Week 6
proportion of patients developing bladder pain or pressure
Time frame: Week 6
proportion of patients requiring repeat outpatient voiding trials
Time frame: Week 6
average number of days postoperatively, that require catheterization
Time frame: Week 6
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 Apr 2024.
- Individual participant dataSharing planned: No
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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.
David Lovejoy, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test Group in people with Voiding Dysfunction, run by Wake Forest University Health Sciences 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 5 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 Apr 2024. 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?
difference in acute voiding dysfunction between a backfill assisted voiding trial (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2024.