Urinary RetentionNCT03009968
Reducing Postoperative Catheterization
A study testing Post-void residual free voiding trial in people with Urinary Retention and Urinary Incontinence, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
After reconstructive pelvic surgery urinary retention occurs in up to 60% of patients requiring an indwelling catheter or self-catheterization (1-5). Up to 35% of women with acute retention experience urinary tract infections in the postoperative period (6, 7). Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Retention, Urinary Incontinence, Pelvic Organ Prolapse
- What is being tested?
- Post-void residual free voiding trial
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2017to 1 Feb 2018
- 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 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The study will include women scheduled for pelvic organ prolapse surgery and/or stress urinary incontinence surgery requiring a post-operative voiding trial.
- 18 years or older
- English speaking
- Documented PVR of less than 100mL prior to surgery obtained either during a previous clinic visit or at the time of their preoperative urodynamics evaluation.
Who cannot join
- Pregnancy
- Dependent on catheterization to void preoperatively
- Patient's undergoing fistula repair, sacral neuromodulation, urethral diverticulum/vaginal mass excision or mesh revision surgery
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7570
About this study
Official title: Reducing Postoperative Catheterization After Urogynecology Surgery: A Randomized Trial
After reconstructive pelvic surgery urinary retention occurs in up to 60% of patients requiring an indwelling catheter or self-catheterization (1-5). Up to 35% of women with acute retention experience urinary tract infections in the postoperative period (6, 7). Many women consider being discharged with a Foley catheter to be a surgical complication and describe catheter use as the worst aspect of their surgery(8). At this time there is no consensus within the field of Female Pelvic Medicine and Reconstructive Surgery (FPMRS) on how to best assess voiding function postoperatively. FPMRS providers both within the United States and around the world utilize a variety of void trial methods and varying criteria to determine adequacy of post-operative voiding efficiency (5).
The traditional backfill assisted void trial method involves the assessment of a postvoid residual (PVR) volume obtained either via catheterization or bladder scan (3). Recently, there have been efforts to determine ways to avoid the assessment of a PVR as it is time-consuming and potentially exposes the patient to additional catheterizations (9, 10). Many FPMRS providers utilize the backfill assisted method without assessing a PVR and instead utilize a certain voided volume threshold to determine adequate voiding. However, to date, no one has directly studied this approach or compared the traditional backfill assisted void trial to a PVR-free backfill assisted void trial. By decreasing catheterization and creating a more efficient void trial method, the investigators hope improve patients' postoperative experience and reduce catheterization and risk of urinary tract infection (UTI).
This study aims to compare two void trial methodologies in order to help standardize post-operative care in the urogynecology population. This study also has potential to lead to an overall change in our field and improve the postoperative course for women across the country and abroad.
Read the detailed description
Data Collection Demographic characteristics (i.e. age, race, body mass index, medical history) will be collected at the time of preoperative visit. On the day of surgery, operative data will be recorded on a standard form to document procedures performed, intra-operative complications (if any), EBL and operative time. Prior to discharge the randomized void trial will be preformed. Data regarding the void trial will be documented on a standard form and will include which void trial was performed, amount backfilled, amount voided, post void residual when assessed, and if the patient was discharged voiding spontaneously, with a Foley catheter or performing CISC. All subjects will be instructed to call our clinical office to report any urinary complaints and treatment for UTI. Information will be collected from electronic medical records regarding any office visits, urine cultures performed or treatment for UTI during this 6-week period. Participants will be called 1 week from the time of surgery to complete the Short-term Catheter Burden Questionnaire.
Pre-operative Visit The preoperative visit may occur up to 3 months prior to surgery. Patients electing to participate in the study will be consented in a private exam to protect confidentiality. Once consented the subjects will be assigned a subject identification number for study identification purposes, which will consist of "A" if the patient's surgery is performed at Rex Hospital or "B" if the patient's surgery is performed at Hillsborough. A number will then follow the letter.
Void Trial Protocols
- Traditional backfill assisted voiding trial (control): Backfill the bladder with up to 300 ml as tolerated of normal saline or sterile water through an indwelling Foley catheter. The catheter is removed and the patient is given 15 minutes to void and the voided volume is measured. A post void residual (PVR) is measured after voiding (or attempt to void) using either an in and out catheter or a bladder scanner. The participant is considered to have passed the void trial if they have a PVR of less than 100 mL or less than half the voided volume if voided volume is greater than 200 mL.
- The post-void residual free voiding trial (intervention): Backfill the bladder with up to 300 ml as tolerated of normal saline or sterile water through an indwelling Foley catheter. The catheter is removed and the patient is given 15 minutes to void and the voided volume is measured. The participant is considered to have passed the void trial if they void more than 1/2 the instilled volume. A PVR will not be performed.
If the participant fails the voiding trial through either method they will be discharged to home with an indwelling catheter or with clean intermittent self-catheterization (CISC) per the participants preference. Subjects with an indwelling catheter will return to clinic within 1-3 days for a repeat voiding trial using the same voiding trial guidelines. If the subject is discharged on clean intermittent self-catheterization (CISC) she will document her voided volumes and PVRs at home. Our nurse will then call the participant every 1-2 business days to determine when they can stop CISC (2 consecutive PVRs less than 100 mL). Nurses will document all information into a standardized template in EPIC per routine clinic protocol.
Follow-Up Participants will be scheduled for their post-operative appointment at the time of scheduling their surgery per usual protocol. They will be called 1 week after surgery to complete a questionnaire. The postoperative visit usually takes place approximately 6 weeks after surgery. Any additional visits or calls to Urogynecology clinic prior to their post-operative appointment will be documented in the electronic medical record per routine clinical practice.
All efforts will be made to ensure minimal loss to follow-up of participants. This plan may include efforts such as telephone follow-up or electronic medical record communication with the patient.
Week 1 Phone Call The patient will be called one week after their surgery to answer the questions from the Short-Term Catheter Burden Questionnaire.
Week 6 Visit (-2 weeks/+2 weeks) The primary outcome will be assessed at the time of the post-operative visit with confirmation of need for catheterization. At this visit the subject will also have the patient complete a questionnaire regarding catheter use.
- Being tested
- Post-void residual free voiding trial
- Medical subject headings
- Urinary Retention, Urinary Incontinence, Pelvic Organ Prolapse, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-void residual free voiding trialOther
Will proceed with voiding trial and assess bladder emptying based on voided amount without checking a post-void residual.
| Study group | Role | What they receive |
|---|---|---|
| Traditional backfill assisted voiding trial | No intervention | Backfill the bladder with up to 300 ml as tolerated of normal saline or sterile water through an indwelling Foley catheter. The catheter is removed and the patient is given 15 minutes to void and the voided volume is measured. A post void residual (PVR) is measured after voiding (or attempt to void) using either an in and out catheter or a bladder scanner. The participant is considered to have passed the void trial if they have a PVR of less than 100 mL or less than half the voided volume if voided volume is greater than 200 mL. |
| Post-void residual free voiding trial | Experimental | The post-void residual free voiding trial (intervention): Backfill the bladder with up to 300 ml as tolerated of normal saline or sterile water through an indwelling Foley catheter. The catheter is removed and the patient is given 15 minutes to void and the voided volume is measured. The participant is considered to have passed the void trial if they void more than 1/2 the instilled volume. A PVR will not be performed. Receives: Other: Post-void residual free voiding trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of postoperative catheterization
Rate of postoperative catheterization which is defined as failing the postoperative voiding trial requiring the patients to be discharged to home with a Foley catheter or using clean intermittent self-catheterization (CISC).
Measured: At the time of hospital discharge (0-1 days)
Secondary outcomes (5)
Duration of catheterization
The number of days the subjects use either an indwelling Foley catheter or clean intermittent self catheterization starting on day of surgery.
Measured: From the day of surgery to 6 weeks post op
Treatment of clinical-suspected or culture proven urinary tract infection
Antibiotic therapy given for either empiric or culture-proven UTI within the 6 week postoperative period. Any UTI treatment provided within our clinic is routinely documented in the EMR with urine culture results available in laboratory results. Patients will also be instructed to have any records from treatment obtained outside the UNC system to be faxed to our research offices. At the 6 week postoperative visits participants will be asked as well whether they received any antibiotic treatment for UTI during the 6 week postoperative period.
Measured: From the day of surgery to 6 weeks post op
Time spent in the Post Anesthesia Care Unit (PACU).
PACU time will be defined as the time from when the patient leaves the OR and the time the patient is discharged from the PACU. This information is routinely recorded in the EMR by anesthesia and nursing staff. This secondary outcome will only be used in participants who are being discharged to home from the PACU.
Measured: 0-24 hours
Short term catheter burden
Short term catheter burden will be assess using a validated 6-item questionnaire that will be completed 1 week following surgery in patients who failed the post operative voiding trial and are sent home with either indwelling Foley catheter or performing CISC.
Measured: 1 week
Number of post-operative patient calls and subsequent clinic visits.
This will be calculated using electronic medical record documentation and will compare the number of post-operative patient calls and subsequent patient visits between the control and intervention group.
Measured: From the day of surgery to 6 weeks post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study start17 Mar 2017
- Primary completion1 Jan 2018
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Responsible party
- Sponsor
- Investigators
- Marcella G Willis-Gray, MD, Principal investigator, UNC at Chapel Hill, Division of Female Pelvic Medicine and Reconstructive Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009968
- Sponsor's protocol ID
- 16-2888
- Status last verified
- Mar 2018
- First submitted
- 2 Jan 2017
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Geller EJ, Hankins KJ, Parnell BA, Robinson BL, Dunivan GC. Diagnostic accuracy of retrograde and spontaneous voiding trials for postoperative voiding dysfunction: a randomized controlled trial. Obstet Gynecol. 2011 Sep;118(3):637-642. doi: 10.1097/AOG.0b013e318229e8dd.
PubMed 21860294Schiotz HA, Tanbo TG. Postoperative voiding, bacteriuria and urinary tract infection with Foley catheterization after gynecological surgery. Acta Obstet Gynecol Scand. 2006;85(4):476-81. doi: 10.1080/00016340500409877.
PubMed 16612711Foster RT Sr, Borawski KM, South MM, Weidner AC, Webster GD, Amundsen CL. A randomized, controlled trial evaluating 2 techniques of postoperative bladder testing after transvaginal surgery. Am J Obstet Gynecol. 2007 Dec;197(6):627.e1-4. doi: 10.1016/j.ajog.2007.08.017.
PubMed 18060956Hakvoort RA, Thijs SD, Bouwmeester FW, Broekman AM, Ruhe IM, Vernooij MM, Burger MP, Emanuel MH, Roovers JP. Comparing clean intermittent catheterisation and transurethral indwelling catheterisation for incomplete voiding after vaginal prolapse surgery: a multicentre randomised trial. BJOG. 2011 Aug;118(9):1055-60. doi: 10.1111/j.1471-0528.2011.02935.x. Epub 2011 Apr 11.
PubMed 21481147Hakvoort RA, Burger MP, Emanuel MH, Roovers JP. A nationwide survey to measure practice variation of catheterisation management in patients undergoing vaginal prolapse surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jul;20(7):813-8. doi: 10.1007/s00192-009-0847-4. Epub 2009 Mar 10.
PubMed 19495543Sutkin G, Alperin M, Meyn L, Wiesenfeld HC, Ellison R, Zyczynski HM. Symptomatic urinary tract infections after surgery for prolapse and/or incontinence. Int Urogynecol J. 2010 Aug;21(8):955-61. doi: 10.1007/s00192-010-1137-x. Epub 2010 Mar 31.
PubMed 20354678Dieter AA, Amundsen CL, Edenfield AL, Kawasaki A, Levin PJ, Visco AG, Siddiqui NY. Oral antibiotics to prevent postoperative urinary tract infection: a randomized controlled trial. Obstet Gynecol. 2014 Jan;123(1):96-103. doi: 10.1097/AOG.0000000000000024.
PubMed 24463669Elkadry EA, Kenton KS, FitzGerald MP, Shott S, Brubaker L. Patient-selected goals: a new perspective on surgical outcome. Am J Obstet Gynecol. 2003 Dec;189(6):1551-7; discussion 1557-8. doi: 10.1016/s0002-9378(03)00932-3.
PubMed 14710061Ingber MS, Vasavada SP, Moore CK, Rackley RR, Firoozi F, Goldman HB. Force of stream after sling therapy: safety and efficacy of rapid discharge care pathway based on subjective patient report. J Urol. 2011 Mar;185(3):993-7. doi: 10.1016/j.juro.2010.10.050. Epub 2011 Jan 19.
PubMed 21247598Tunitsky-Bitton E, Murphy A, Barber MD, Goldman HB, Vasavada S, Jelovsek JE. Assessment of voiding after sling: a randomized trial of 2 methods of postoperative catheter management after midurethral sling surgery for stress urinary incontinence in women. Am J Obstet Gynecol. 2015 May;212(5):597.e1-9. doi: 10.1016/j.ajog.2014.11.033. Epub 2014 Nov 27.
PubMed 25434837Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Obstet Gynecol. 2010 May;115(5):1063-1070. doi: 10.1097/AOG.0b013e3181d9d421. No abstract available.
PubMed 20410783Willis-Gray MG, Wu JM, Field C, Pulliam S, Husk KE, Brueseke TJ, Geller EJ, Connolly A, Dieter AA. Is a Postvoid Residual Necessary? A Randomized Trial of Two Postoperative Voiding Protocols. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):e256-e260. doi: 10.1097/SPV.0000000000000743.
PubMed 31157716
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Postoperative Catheterization After Urogynecology Surgery: A Randomized Trial
- ClinicalTrials.gov ID
- NCT03009968
- Acronym / sponsor ID
- 16-2888
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Study start
- 17 Mar 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 4 Jan 2017 (estimated)
- 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.
After reconstructive pelvic surgery urinary retention occurs in up to 60% of patients requiring an indwelling catheter or self-catheterization (1-5). Up to 35% of women with acute retention experience urinary tract infections in the postoperative period (6, 7). Many women consider being discharged with a Foley catheter to be a surgical complication and describe catheter use as the worst aspect of their surgery(8). At this time there is no consensus within the field of Female Pelvic Medicine and Reconstructive Surgery (FPMRS) on how to best assess voiding function postoperatively. FPMRS providers both within the United States and around the world utilize a variety of void trial methods and varying criteria to determine adequacy of post-operative voiding efficiency (5).
The traditional backfill assisted void trial method involves the assessment of a postvoid residual (PVR) volume obtained either via catheterization or bladder scan (3). Recently, there have been efforts to determine ways to avoid the assessment of a PVR as it is time-consuming and potentially exposes the patient to additional catheterizations (9, 10). Many FPMRS providers utilize the backfill assisted method without assessing a PVR and instead utilize a certain voided volume threshold to determine adequate voiding. However, to date, no one has directly studied this approach or compared the traditional backfill assisted void trial to a PVR-free backfill assisted void trial. By decreasing catheterization and creating a more efficient void trial method, the investigators hope improve patients' postoperative experience and reduce catheterization and risk of urinary tract infection (UTI).
This study aims to compare two void trial methodologies in order to help standardize post-operative care in the urogynecology population. This study also has potential to lead to an overall change in our field and improve the postoperative course for women across the country and abroad.
Detailed description
Data Collection Demographic characteristics (i.e. age, race, body mass index, medical history) will be collected at the time of preoperative visit. On the day of surgery, operative data will be recorded on a standard form to document procedures performed, intra-operative complications (if any), EBL and operative time. Prior to discharge the randomized void trial will be preformed. Data regarding the void trial will be documented on a standard form and will include which void trial was performed, amount backfilled, amount voided, post void residual when assessed, and if the patient was discharged voiding spontaneously, with a Foley catheter or performing CISC. All subjects will be instructed to call our clinical office to report any urinary complaints and treatment for UTI. Information will be collected from electronic medical records regarding any office visits, urine cultures performed or treatment for UTI during this 6-week period. Participants will be called 1 week from the time of surgery to complete the Short-term Catheter Burden Questionnaire.
Pre-operative Visit The preoperative visit may occur up to 3 months prior to surgery. Patients electing to participate in the study will be consented in a private exam to protect confidentiality. Once consented the subjects will be assigned a subject identification number for study identification purposes, which will consist of "A" if the patient's surgery is performed at Rex Hospital or "B" if the patient's surgery is performed at Hillsborough. A number will then follow the letter.
Void Trial Protocols
- Traditional backfill assisted voiding trial (control): Backfill the bladder with up to 300 ml as tolerated of normal saline or sterile water through an indwelling Foley catheter. The catheter is removed and the patient is given 15 minutes to void and the voided volume is measured. A post void residual (PVR) is measured after voiding (or attempt to void) using either an in and out catheter or a bladder scanner. The participant is considered to have passed the void trial if they have a PVR of less than 100 mL or less than half the voided volume if voided volume is greater than 200 mL.
- The post-void residual free voiding trial (intervention): Backfill the bladder with up to 300 ml as tolerated of normal saline or sterile water through an indwelling Foley catheter. The catheter is removed and the patient is given 15 minutes to void and the voided volume is measured. The participant is considered to have passed the void trial if they void more than 1/2 the instilled volume. A PVR will not be performed.
If the participant fails the voiding trial through either method they will be discharged to home with an indwelling catheter or with clean intermittent self-catheterization (CISC) per the participants preference. Subjects with an indwelling catheter will return to clinic within 1-3 days for a repeat voiding trial using the same voiding trial guidelines. If the subject is discharged on clean intermittent self-catheterization (CISC) she will document her voided volumes and PVRs at home. Our nurse will then call the participant every 1-2 business days to determine when they can stop CISC (2 consecutive PVRs less than 100 mL). Nurses will document all information into a standardized template in EPIC per routine clinic protocol.
Follow-Up Participants will be scheduled for their post-operative appointment at the time of scheduling their surgery per usual protocol. They will be called 1 week after surgery to complete a questionnaire. The postoperative visit usually takes place approximately 6 weeks after surgery. Any additional visits or calls to Urogynecology clinic prior to their post-operative appointment will be documented in the electronic medical record per routine clinical practice.
All efforts will be made to ensure minimal loss to follow-up of participants. This plan may include efforts such as telephone follow-up or electronic medical record communication with the patient.
Week 1 Phone Call The patient will be called one week after their surgery to answer the questions from the Short-Term Catheter Burden Questionnaire.
Week 6 Visit (-2 weeks/+2 weeks) The primary outcome will be assessed at the time of the post-operative visit with confirmation of need for catheterization. At this visit the subject will also have the patient complete a questionnaire regarding catheter use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional backfill assisted voiding trial | No intervention | –Backfill the bladder with up to 300 ml as tolerated of normal saline or sterile water through an indwelling Foley catheter. The catheter is removed and the patient is given 15 minutes to void and the voided volume is measured. A post void residual (PVR) is measured after voiding (or attempt to void) using either an in and out catheter or a bladder scanner. The participant is considered to have passed the void trial if they have a PVR of less than 100 mL or less than half the voided volume if voided volume is greater than 200 mL. |
| Post-void residual free voiding trial | Experimental | Other: Post-void residual free voiding trialThe post-void residual free voiding trial (intervention): Backfill the bladder with up to 300 ml as tolerated of normal saline or sterile water through an indwelling Foley catheter. The catheter is removed and the patient is given 15 minutes to void and the voided volume is measured. The participant is considered to have passed the void trial if they void more than 1/2 the instilled volume. A PVR will not be performed. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The study will include women scheduled for pelvic organ prolapse surgery and/or stress urinary incontinence surgery requiring a post-operative voiding trial.
- 18 years or older
- English speaking
- Documented PVR of less than 100mL prior to surgery obtained either during a previous clinic visit or at the time of their preoperative urodynamics evaluation.
Key exclusion criteria (4 listed)
- Pregnancy
- Dependent on catheterization to void preoperatively
- Patient's undergoing fistula repair, sacral neuromodulation, urethral diverticulum/vaginal mass excision or mesh revision surgery
- Inability to give informed consent
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 |
|---|---|---|
| Post-void residual free voiding trialWill proceed with voiding trial and assess bladder emptying based on voided amount without checking a post-void residual. | Other | Post-void residual free voiding trial |
Primary outcome
Rate of postoperative catheterization
Time frame: At the time of hospital discharge (0-1 days)
Rate of postoperative catheterization which is defined as failing the postoperative voiding trial requiring the patients to be discharged to home with a Foley catheter or using clean intermittent self-catheterization (CISC).
5 secondary outcomes
Duration of catheterization
Time frame: From the day of surgery to 6 weeks post op
Treatment of clinical-suspected or culture proven urinary tract infection
Time frame: From the day of surgery to 6 weeks post op
Time spent in the Post Anesthesia Care Unit (PACU).
Time frame: 0-24 hours
Short term catheter burden
Time frame: 1 week
Number of post-operative patient calls and subsequent clinic visits.
Time frame: From the day of surgery to 6 weeks post op
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 19 Mar 2018.
- Background: PubMed 21860294Geller EJ, Hankins KJ, Parnell BA, Robinson BL, Dunivan GC. Diagnostic accuracy of retrograde and spontaneous voiding trials for postoperative voiding dysfunction: a randomized controlled trial. Obstet Gynecol. 2011 Sep;118(3):637-642. doi: 10.1097/AOG.0b013e318229e8dd.
- Background: PubMed 16612711Schiotz HA, Tanbo TG. Postoperative voiding, bacteriuria and urinary tract infection with Foley catheterization after gynecological surgery. Acta Obstet Gynecol Scand. 2006;85(4):476-81. doi: 10.1080/00016340500409877.
- Background: PubMed 18060956Foster RT Sr, Borawski KM, South MM, Weidner AC, Webster GD, Amundsen CL. A randomized, controlled trial evaluating 2 techniques of postoperative bladder testing after transvaginal surgery. Am J Obstet Gynecol. 2007 Dec;197(6):627.e1-4. doi: 10.1016/j.ajog.2007.08.017.
- Background: PubMed 21481147Hakvoort RA, Thijs SD, Bouwmeester FW, Broekman AM, Ruhe IM, Vernooij MM, Burger MP, Emanuel MH, Roovers JP. Comparing clean intermittent catheterisation and transurethral indwelling catheterisation for incomplete voiding after vaginal prolapse surgery: a multicentre randomised trial. BJOG. 2011 Aug;118(9):1055-60. doi: 10.1111/j.1471-0528.2011.02935.x. Epub 2011 Apr 11.
- Background: PubMed 19495543Hakvoort RA, Burger MP, Emanuel MH, Roovers JP. A nationwide survey to measure practice variation of catheterisation management in patients undergoing vaginal prolapse surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jul;20(7):813-8. doi: 10.1007/s00192-009-0847-4. Epub 2009 Mar 10.
- Background: PubMed 20354678Sutkin G, Alperin M, Meyn L, Wiesenfeld HC, Ellison R, Zyczynski HM. Symptomatic urinary tract infections after surgery for prolapse and/or incontinence. Int Urogynecol J. 2010 Aug;21(8):955-61. doi: 10.1007/s00192-010-1137-x. Epub 2010 Mar 31.
- Background: PubMed 24463669Dieter AA, Amundsen CL, Edenfield AL, Kawasaki A, Levin PJ, Visco AG, Siddiqui NY. Oral antibiotics to prevent postoperative urinary tract infection: a randomized controlled trial. Obstet Gynecol. 2014 Jan;123(1):96-103. doi: 10.1097/AOG.0000000000000024.
- Background: PubMed 14710061Elkadry EA, Kenton KS, FitzGerald MP, Shott S, Brubaker L. Patient-selected goals: a new perspective on surgical outcome. Am J Obstet Gynecol. 2003 Dec;189(6):1551-7; discussion 1557-8. doi: 10.1016/s0002-9378(03)00932-3.
- Background: PubMed 21247598Ingber MS, Vasavada SP, Moore CK, Rackley RR, Firoozi F, Goldman HB. Force of stream after sling therapy: safety and efficacy of rapid discharge care pathway based on subjective patient report. J Urol. 2011 Mar;185(3):993-7. doi: 10.1016/j.juro.2010.10.050. Epub 2011 Jan 19.
- Background: PubMed 25434837Tunitsky-Bitton E, Murphy A, Barber MD, Goldman HB, Vasavada S, Jelovsek JE. Assessment of voiding after sling: a randomized trial of 2 methods of postoperative catheter management after midurethral sling surgery for stress urinary incontinence in women. Am J Obstet Gynecol. 2015 May;212(5):597.e1-9. doi: 10.1016/j.ajog.2014.11.033. Epub 2014 Nov 27.
- Background: PubMed 20410783Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Obstet Gynecol. 2010 May;115(5):1063-1070. doi: 10.1097/AOG.0b013e3181d9d421. No abstract available.
- Derived from this study: PubMed 31157716Willis-Gray MG, Wu JM, Field C, Pulliam S, Husk KE, Brueseke TJ, Geller EJ, Connolly A, Dieter AA. Is a Postvoid Residual Necessary? A Randomized Trial of Two Postoperative Voiding Protocols. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):e256-e260. doi: 10.1097/SPV.0000000000000743.
- Individual participant dataSharing planned: No
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Overactive Bladder (OAB), Urgency Urinary Incontinence
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
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
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.
Marcella G Willis-Gray, MD principal investigator
UNC at Chapel Hill, Division of Female Pelvic Medicine and Reconstructive Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post-void residual free voiding trial in people with Urinary Retention and Urinary Incontinence, run by University of North Carolina, Chapel Hill 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 4 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: finished, as of the sponsor's last update on 19 Mar 2018. 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?
Rate of postoperative catheterization (time frame: At the time of hospital discharge (0-1 days)). 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 NCT03009968, which also lists 12 linked publications.
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 19 Mar 2018.