Urinary IncontinenceNCT03539107
Voiding Assessment Based on Minimum Spontaneous Void of 150 mL Compared to Retrograde Fill Method After Female Pelvic Floor Reconstructive Surgery
A study testing Retrograde bladder fill and spontaneous void in people with Urinary Incontinence and Pelvic Organ Prolapse, run by Yale University at 1 site in United States.
Trial summary
This study will compare voiding assessment based on a minimum spontaneous voided volume of 150 cc with the standard retrograde fill approach in women after pelvic floor procedures. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Pelvic Organ Prolapse
- What is being tested?
- Retrograde bladder fill and spontaneous void
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 20 Dec 2019
- 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
- All 18-year-old or older women who undergo surgery for urinary incontinence and/or pelvic organ prolapse (POP)
Who cannot join
- Patients who require prolonged Foley catheter or suprapubic catheter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Voiding Assessment Based on Minimum Spontaneous Void of 150 mL Compared to Retrograde Fill Method After Female Pelvic Floor Reconstructive Surgery: A Randomized Controlled Trial
This study will compare voiding assessment based on a minimum spontaneous voided volume of 150 cc with the standard retrograde fill approach in women after pelvic floor procedures.
- Conditions
- Urinary Incontinence, Pelvic Organ Prolapse
- Being tested
- Retrograde bladder fill, spontaneous void
- Medical subject headings
- Urinary Incontinence, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrograde bladder fillProcedure or surgery
Subjects will have their bladder retrograde filled with 300mL of fluid prior to a voiding trial.
spontaneous voidOther
Subjects will not have retrograde fill of bladder, rather will be required to void 150 mL spontaneously prior to discharge.
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous void | Experimental | Subjects will not have retrograde fill of bladder, rather will be required to void 150 mL spontaneously prior to discharge. Receives: Other: spontaneous void |
| Retrograde bladder fill | Active comparator | Subjects will have their bladder retrograde filled with 300mL of fluid prior to a voiding trial. Receives: Procedure: Retrograde bladder fill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure rate
The percentage of subjects who did not meet the required voiding assessment criteria and needed catheterization .
Measured: Up to 2 days post op
Secondary outcomes (12)
False pass rate
The percentage of women who initially met the voiding assessment but returned for re-catheterization due to voiding difficulty .
Measured: up to 30 days after discharge.
Force of stream (FOS)
Patient reported force of stream (FOS) during voiding; (0 being no urination, 10 being normal strong flow).
Measured: Up to 2 days post op.
Force of stream (FOS)
Patient reported force of stream (FOS) during voiding; (0 being no urination, 10 being normal strong flow).
Measured: Up to 2 days post-surgery.
Patient Satisfaction Questionnaire for Voiding Assessment-method used
This question asks "How satisfied were you with the method we used to evaluate how well you could urinate after our surgery?" It is measured on a continuum from 0 (very dissatisfied) to 100 (very satisfied).
Measured: Up to 2 days post-surgery.
Patient Satisfaction Questionnaire for Voiding Assessment-negative emotions
This question asks "Did you experience any negative emotions such as fear or anxiety when we were evaluating urination after our surgery?" It is measured on a continuum from 0 (many negative emotions) to 100 (no negative emotions).
Measured: Up to 2 days post-surgery.
Patient Satisfaction Questionnaire for Voiding Assessment-recommend method
This question asks "How likely would you be to recommend to a friend or family member, the method we used to evaluate your urination after our surgery, if they were in the same situation?" It is measured on a continuum from 0 (very unlikely) to 100 (very likely).
Measured: Up to 2 days post-surgery.
Patient Satisfaction Questionnaire for Voiding Assessment-convenience of method
This question asks "How convenient was the method we used to evaluate your urination after our surgery (e.g. time, ease etc.)? It is measured on a continuum from 0 (very inconvenient) to 100 (very convenient).
Measured: Up to 2 days post-surgery.
Patient Satisfaction Questionnaire for Voiding Assessment-preferred method
This question asks the patient: "If it was all up to you, which It is measured on a continuum from 0 (strongly prefer backfill before catheter) to 100 (strongly prefer no backfill before catheter removal).
Measured: Up to 2 days post-surgery.
Postoperative pain score
This outcome is measured by a 10-point visual analog scale where 0= no pain, 10=worst pain you have ever experienced.
Measured: One day post-surgery.
Urinary tract infection (UTI)
UTI is defined as culture-proven bladder infection or, in the absence of a culture, clinical suspicion of a bladder infection that resulted in treatment.
Measured: Up to 30 days post surgery.
Post-operative complications
Post-operative complications assessed by medical record review.
Measured: Up to 30 days post-surgery.
Length of hospital stay
Length of hospital stay assessed by medical record review.
Measured: Up to 2 days post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start1 Sep 2019
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
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 Urinary IncontinenceStudies 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
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harmanli Oz, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539107
- Sponsor's protocol ID
- Popiel02
- Status last verified
- Jan 2020
- First submitted
- 15 May 2018
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
PubMed 34184246
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voiding Assessment Based on Minimum Spontaneous Void of 150 mL Compared to Retrograde Fill Method After Female Pelvic Floor Reconstructive Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03539107
- Acronym / sponsor ID
- Popiel02
- Conditions
- Urinary Incontinence, Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 29 May 2018 (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.
This study will compare voiding assessment based on a minimum spontaneous voided volume of 150 cc with the standard retrograde fill approach in women after pelvic floor procedures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spontaneous void | Experimental | Other: spontaneous voidSubjects will not have retrograde fill of bladder, rather will be required to void 150 mL spontaneously prior to discharge. |
| Retrograde bladder fill | Active comparator | Procedure: Retrograde bladder fillSubjects will have their bladder retrograde filled with 300mL of fluid prior to a voiding trial. |
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)
- All 18-year-old or older women who undergo surgery for urinary incontinence and/or pelvic organ prolapse (POP)
Key exclusion criteria (1 listed)
- Patients who require prolonged Foley catheter or suprapubic catheter
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 |
|---|---|---|
| Retrograde bladder fillSubjects will have their bladder retrograde filled with 300mL of fluid prior to a voiding trial. | Procedure or surgery | Retrograde bladder fill |
| spontaneous voidSubjects will not have retrograde fill of bladder, rather will be required to void 150 mL spontaneously prior to discharge. | Other | Spontaneous void |
Primary outcome
Failure rate
Time frame: Up to 2 days post op
The percentage of subjects who did not meet the required voiding assessment criteria and needed catheterization .
12 secondary outcomes
False pass rate
Time frame: up to 30 days after discharge.
Force of stream (FOS)
Time frame: Up to 2 days post op.
Force of stream (FOS)
Time frame: Up to 2 days post-surgery.
Patient Satisfaction Questionnaire for Voiding Assessment-method used
Time frame: Up to 2 days post-surgery.
Patient Satisfaction Questionnaire for Voiding Assessment-negative emotions
Time frame: Up to 2 days post-surgery.
Patient Satisfaction Questionnaire for Voiding Assessment-recommend method
Time frame: Up to 2 days post-surgery.
Patient Satisfaction Questionnaire for Voiding Assessment-convenience of method
Time frame: Up to 2 days post-surgery.
Patient Satisfaction Questionnaire for Voiding Assessment-preferred method
Time frame: Up to 2 days post-surgery.
Postoperative pain score
Time frame: One day post-surgery.
Urinary tract infection (UTI)
Time frame: Up to 30 days post surgery.
Post-operative complications
Time frame: Up to 30 days post-surgery.
Length of hospital stay
Time frame: Up to 2 days post-surgery.
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 13 Jan 2020.
- Derived from this study: PubMed 34184246Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
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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.
Harmanli Oz, MD 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 Retrograde bladder fill and spontaneous void in people with Urinary Incontinence and Pelvic Organ Prolapse, 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 13 Jan 2020. 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?
Failure rate (time frame: Up to 2 days post op). 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 NCT03539107, 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 13 Jan 2020.