Urinary RetentionCATHNCT05860634
Urinary Catheter Self-Discontinuation After Urogynecology Surgery
A study testing Catheter self-discontinuation in people with Urinary Retention and Pelvic Organ Prolapse, run by University of Texas at Austin at 4 sites in United States.
Trial summary
The goal of this randomized clinical trial is to determine if removal of transurethral urinary catheters by patients at home is as safe as catheter removal in the office following urogynecologic surgery. Participants will be randomized to either standard catheter removal in the office or catheter self-removal at home. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Retention, Pelvic Organ Prolapse, Stress Urinary Incontinence
- What is being tested?
- Catheter self-discontinuation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Aug 2023to 1 Nov 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are at least 18 years of age
- Are fluent and able to read in English or Spanish
- Undergo POP and/or SUI surgery (uterosacral ligament suspension, sacrospinous ligament fixation, sacral colpopexy, anterior colporrhaphy, posterior colporrhaphy, and/or mid-urethral sling) that occurs on Monday - Thursday
- Have transurethral catheter in place at the conclusion of surgery as part of standard care
- Are diagnosed with POUR on POD0 based on ultrasound bladder scan PVR of 100 mL or more
- Are discharged home on the same day of surgery (POD 0)
Who cannot join
- Have preoperative voiding dysfunction requiring self-catheterization or indwelling transurethral catheter
- Have physical or mental impairment that would impact their ability to remove their catheter themselves.
- Undergo urethral bulking injections as part of surgery
- Have undergone a planned or unplanned urinary tract procedure requiring prolonged catheterization as standard of care (e.g. cystotomy repair, ureteral reimplantation, vesicovaginal fistula repair, urethral diverticulum repair)
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
University of Texas of Austin - Dell Seton Medical Center
Austin, Texas, 78701
Collin M McKenzie, MD, 512-324-8670, collin.mckenzie@austin.utexas.edu
- Recruiting
Seton Medical Center Austin
Austin, Texas, 78705
Collin M McKenzie, MD, 512-324-8670, collin.mckenzie@austin.utexas.edu
- Recruiting
Ascension Seton Hays Hospital
Kyle, Texas, 78640
Collin M McKenzie, MD, 512-324-8670, collin.mckenzie@austin.utexas.edu
- Recruiting
Seton Medical Center Williamson
Round Rock, Texas, 78665
Collin M McKenzie, MD, 512-324-8670, collin.mckenzie@austin.utexas.edu
About this study
The goal of this randomized clinical trial is to determine if removal of transurethral urinary catheters by patients at home is as safe as catheter removal in the office following urogynecologic surgery.
Participants will be randomized to either standard catheter removal in the office or catheter self-removal at home.
Read the detailed description
This is a prospective, randomized, two-parallel arm, non-inferiority trial to evaluate two methods of catheter discontinuation in women with post-operative urinary retention (POUR) after surgery for pelvic organ prolapse (POP) or stress urinary incontinence (SUI). This study will evaluate whether self-discontinuation of transurethral catheter by patients is non-inferior to standard office discontinuation based on rates of persistent POUR on post-operative day (POD) 1.
- Conditions
- Urinary Retention, Pelvic Organ Prolapse, Stress Urinary Incontinence, Catheter Related Complication
- Being tested
- Catheter self-discontinuation
- Keywords
- Post-operative urinary retention, Pelvic organ prolapse, Stress urinary incontinence, Cather self-discontinuation
- Medical subject headings
- Urinary Retention, Pelvic Organ Prolapse, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter self-discontinuationProcedure or surgery
Self-discontinuation of a transurethral catheter
| Study group | Role | What they receive |
|---|---|---|
| Catheter office-discontinuation group | No intervention | The patients randomized to the office-discontinuation group will visit the office for a repeat voiding trial on postoperative day 1. At this visit, the patients will undergo a backfill voiding trial. |
| Catheter self-discontinuation group | Experimental | The patients randomized to the catheter self-discontinuation group will be provided with a diagrammatic handout and will be instructed to remove their indwelling urinary catheter at home on the morning of Postoperative day 1. Receives: Procedure: Catheter self-discontinuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Postoperative Urinary Retention
Non-inferiority comparison of the rates of persistent POUR on POD1 between catheter self-discontinuation and standard office catheter. Persistent POUR is defined as PVR greater than 100 mL by bladder scan on POD1.
Measured: Post-operative day 1
Secondary outcomes (5)
Rates of postoperative urinary tract infection (UTI)
Rates of postoperative UTI within 6 weeks of surgery - UTI will be defined as treatment with antibiotics for symptoms of UTI.
Measured: within 6 weeks of surgery
Incidence of recurrent POUR
Recurrent POUR will be defined as any participant with successful POD1 voiding trial who later requires replacement of catheter due to recurrent POUR within 6 weeks of surgery. Recurrent POUR is defined as PVR greater than 100 mL by bladder scan after passing initial POD1 voiding trial.
Measured: within 6 weeks of surgery
Number of postoperative patient encounters
Number of postoperative patient encounters, including any patient call to the office, electronic medical record message to office from patient, office visit, or emergency department visit.
Measured: within 6 weeks of surgery
Patient satisfaction assessment via the Acceptability of Intervention Measure (AIM) Questionnaire
Patient satisfaction with catheter removal method as assessed via the Acceptability of Intervention Measure (AIM) Questionnaire.
The AIM Questionnaire is a 4-item questionnaire on a 5-point Likert scale. Response Scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree Scoring Instructions: Scale is created by averaging responses. Scale values range from 1 to 5.
The higher the score is, the higher the degree the patient finds the intervention acceptable.
Measured: Post-operative day 1
Patient satisfaction assessment via the the Surgical Satisfaction Questionnaire - 8 (SSQ-8).
Patient satisfaction with catheter removal method as assessed via the Surgical Satisfaction Questionnaire - 8 (SSQ-8).
The SSQ-8 is an 8-item questionnaire, with responses recorded on a 5-point Likert scale with responses from 0 "Very Unsatisfied" to 4 "Very Satisfied." Scoring uses the mean average of the 8 scores being multiplied by 25 (the questionnaire is considered incomplete if more than 2 items are not answered), yielding a potential range of scores from 0 to 100. The higher the score is, the greater the degree of surgical satisfaction.
Measured: Post-operative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start1 Aug 2023
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe 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
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary M Rieger, MD, Principal investigator, University of Texas at AustinCollin M McKenzie, MD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860634
- Sponsor's protocol ID
- STUDY00004321
- Acronym
- CATH
- Status last verified
- Jan 2024
- First submitted
- 27 Apr 2023
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Catheter Self-Discontinuation After Urogynecology Surgery
- ClinicalTrials.gov ID
- NCT05860634
- Acronym / sponsor ID
- CATH / STUDY00004321
- Conditions
- Urinary Retention, Pelvic Organ Prolapse, Stress Urinary Incontinence, Catheter Related Complication
- Keywords
- Post-operative urinary retention, Pelvic organ prolapse, Stress urinary incontinence, Cather self-discontinuation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 16 May 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.
The goal of this randomized clinical trial is to determine if removal of transurethral urinary catheters by patients at home is as safe as catheter removal in the office following urogynecologic surgery.
Participants will be randomized to either standard catheter removal in the office or catheter self-removal at home.
Detailed description
This is a prospective, randomized, two-parallel arm, non-inferiority trial to evaluate two methods of catheter discontinuation in women with post-operative urinary retention (POUR) after surgery for pelvic organ prolapse (POP) or stress urinary incontinence (SUI). This study will evaluate whether self-discontinuation of transurethral catheter by patients is non-inferior to standard office discontinuation based on rates of persistent POUR on post-operative day (POD) 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter office-discontinuation group | No intervention | –The patients randomized to the office-discontinuation group will visit the office for a repeat voiding trial on postoperative day 1. At this visit, the patients will undergo a backfill voiding trial. |
| Catheter self-discontinuation group | Experimental | Procedure: Catheter self-discontinuationThe patients randomized to the catheter self-discontinuation group will be provided with a diagrammatic handout and will be instructed to remove their indwelling urinary catheter at home on the morning of Postoperative day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are at least 18 years of age
- Are fluent and able to read in English or Spanish
- Undergo POP and/or SUI surgery (uterosacral ligament suspension, sacrospinous ligament fixation, sacral colpopexy, anterior colporrhaphy, posterior colporrhaphy, and/or mid-urethral sling) that occurs on Monday - Thursday
- Have transurethral catheter in place at the conclusion of surgery as part of standard care
- Are diagnosed with POUR on POD0 based on ultrasound bladder scan PVR of 100 mL or more
Key exclusion criteria (4 listed)
- Have preoperative voiding dysfunction requiring self-catheterization or indwelling transurethral catheter
- Have physical or mental impairment that would impact their ability to remove their catheter themselves.
- Undergo urethral bulking injections as part of surgery
- Have undergone a planned or unplanned urinary tract procedure requiring prolonged catheterization as standard of care (e.g. cystotomy repair, ureteral reimplantation, vesicovaginal fistula repair, urethral diverticulum repair)
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 |
|---|---|---|
| Catheter self-discontinuationSelf-discontinuation of a transurethral catheter | Procedure or surgery | Catheter self-discontinuation group |
Primary outcome
Number of Participants With Postoperative Urinary Retention
Time frame: Post-operative day 1
Non-inferiority comparison of the rates of persistent POUR on POD1 between catheter self-discontinuation and standard office catheter. Persistent POUR is defined as PVR greater than 100 mL by bladder scan on POD1.
5 secondary outcomes
Rates of postoperative urinary tract infection (UTI)
Time frame: within 6 weeks of surgery
Incidence of recurrent POUR
Time frame: within 6 weeks of surgery
Number of postoperative patient encounters
Time frame: within 6 weeks of surgery
Patient satisfaction assessment via the Acceptability of Intervention Measure (AIM) Questionnaire
Time frame: Post-operative day 1
Patient satisfaction assessment via the the Surgical Satisfaction Questionnaire - 8 (SSQ-8).
Time frame: Post-operative day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Urinary Retention
Not yet recruiting
Effect of Voiding Position (Standing in the Shower vs. Sitting) on Post- Void Residual Urine Volume (PVR) After Removal of Urinary Catheter in Women Following Vaginal Delivery With Epidural Analgesia: A Double- Blind Randomized Controlled Trial
Postpartum Urinary Retention
Recruiting
Pelvic Health Electrically Evoked Recording (PEER) 2 Study
Overactive Bladder, Fecal Incontinence
Not yet recruitingObservational study
Long-Term Effectiveness and Safety of Sacral Neuromodulation With InterStim for Lower Urinary Tract Dysfunction
Overactive Bladder (OAB), Urgency Urinary Incontinence
Recruiting
Evaluating the Clinical Efficacy of Thulio vs. Holmium Laser Enucleation of the Prostate
BPH With Symptomatic Lower Urinary Tract Symptoms, BPH With Urinary Obstruction
Active, not recruiting
Preoperative Pelvic Floor Physical Therapy to Minimize Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate
Benign Prostatic Hyperplasia With Outflow Obstruction, Urinary Retention
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.
Mary M Rieger, MD principal investigator
University of Texas at Austin
Collin M McKenzie, MD principal investigator
University of Texas at Austin
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter self-discontinuation in people with Urinary Retention and Pelvic Organ Prolapse, run by University of Texas at Austin at 4 sites 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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mary M Rieger, MD (512-324-8670, mary.rieger@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Postoperative Urinary Retention (time frame: Post-operative day 1). 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 11 Dec 2024.