Urinary Retention PostoperativeOPTIONNCT04010656
Optimization of Spontaneous Postoperative Trial of Void Among Women
A study testing PVR-based self-catheterization in people with Urinary Retention Postoperative and Voiding Disorders, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial summary
Trial of void (TOV) is a diagnostic test performed on all women who undergo prolapse repair or incontinence surgery, due to the importance of diagnosing postoperative urinary retention (POUR). Incidence of POUR may be as high as 62% in some studies. 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 Postoperative, Voiding Disorders
- What is being tested?
- PVR-based self-catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2018to 30 Dec 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English-speaking women, age >18yo
- Scheduled for urogynecology procedure which will need post-operative trial of void (including pelvic organ prolapse and/or stress urinary incontinence repair), with plan for same-day discharge.
Who cannot join
- Unable or unwilling to perform self-catheterizatoin either by patient or willing family member
- Pre-existing voiding dysfunction defined as documented PVR > 200 mL
- Intraoperative urinary tract injury needing indwelling catheter on discharge
- Need for overnight admission
Trial locations and contacts
1 site in 1 country.
United States1 site
Women & Infants Hospital
Providence, Rhode Island, 02903
About this study
Official title: Optimization of Spontaneous Trial of Void: a Prospective Cohort Study
Trial of void (TOV) is a diagnostic test performed on all women who undergo prolapse repair or incontinence surgery, due to the importance of diagnosing postoperative urinary retention (POUR). Incidence of POUR may be as high as 62% in some studies. Timely and accurate diagnosis is important to avoid complications such as urinary tract infection, bladder overdistension, and permanent bladder injury. Despite the frequent use of TOV, there is no gold standard for the test, and it likely has poor specificity, leading to discharge of more patients with catheter than required. This prospective cohort study will seek to establish evidence-based optimal parameters for spontaneous trial of void, a TOV modality that has merit for further evaluation given lower theoretical risk of urinary tract infection.
Read the detailed description
Patients will learn to perform self-catheterization ('clean intermittent catheterization', or CIC) preoperatively; after surgery, the investigators will collect a range of voiding parameters used during different TOV protocols (including minimum voided volume [MVV], post-void residual via bladder scanner [PVR], subjective force of urinary stream [sFOS]). Patients will discharge home to perform CIC until two sequential post-void residuals of less than half the volume voided have been achieved. The rate of voiding dysfunction and resulting PVRs will be used to compare the diagnostic accuracy of the perioperative voiding parameters to predict need to perform CIC and post-operative urinary retention.
- Conditions
- Urinary Retention Postoperative, Voiding Disorders
- Being tested
- PVR-based self-catheterization
- Keywords
- Urogynecologic surgery, Urinary retention postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVR-based self-catheterizationProcedure or surgery
Home self-catheterization based on standard of care
| Study group | Role | What they receive |
|---|---|---|
| PVR-based home self-catheterization | Experimental | Patients will learn to self-catheterize preoperatively prior to urogynecology surgery requiring trial of void. First post-operative void will be used to collect basic information about voiding function. All participants will leave the hospital and self-catheterize until they achieve two sequential voids with post-void residual (PVR) less than half the volume voided. The cases of urinary retention captured with abnormal PVR will be used to compare the diagnostic accuracy of several commonly-used, pre-defined parameters for trial of void. Receives: Procedure: PVR-based self-catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-operative urinary retention
Based on defined criteria
Measured: 24-72 hours postoperative
Diagnostic accuracy of trial of void parameters
Comparison of sensitivity, specificity, positive/negative predictive value of different trial of void parameters from first postoperative void, based on those used in the literature.
Measured: First void postoperative (within 4 hours postop)
Secondary outcomes (4)
Rate of post-operative and post-discharge urinary retention
Based on post-void residual volume
Measured: 24-72 hours postoperative
Rate of post-operative urinary tract infection
UTI in first 6 weeks postoperative
Measured: 6 weeks postoperative
Patient satisfaction with self-catheterization method via questionnaire
Novel questionnaire, 5 point Likert scale from "Very dissatisfied to Very satisfied"
Measured: 2 weeks postoperative
Time to first void postoperative
To assess time to spontaneous void after surgery
Measured: 4 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start10 Sep 2018
- Primary completion10 May 2021
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Urinary Retention PostoperativeStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will be taught to perform self-catheterization prior to prolapse repair or incontinence surgery; voiding data will be collected on the participant's first void after surgery. Participants will be discharged home to perform self-catheterization until post-void residual is less than half the volume voided on 2 sequential voids to assess actual voiding function, and this data will be used to calculate the diagnostic accuracy of pre-determined combinations of the TOV parameters.
- Masking
- None (open label)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- American Urogynecologic Society, American Association of Gynecologic Laparoscopists
- Responsible party
- Principal investigator, Anne Cooper, MD, Dartmouth-Hitchcock Medical Center
- Investigators
- Anne C Cooper, MD, MA, Principal investigator, Dartmouth-Hitchcock Medical Center, Lebanon NHJulia Shinnick, MD, Principal investigator, Women & Infants Hospital, Providence RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010656
- Sponsor's protocol ID
- WIH IRB 1145237
- Acronym
- OPTION
- Status last verified
- Jul 2021
- First submitted
- 19 Feb 2019
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dorflinger A, Monga A. Voiding dysfunction. Curr Opin Obstet Gynecol. 2001 Oct;13(5):507-12. doi: 10.1097/00001703-200110000-00010.
PubMed 11547032Partoll LM. Efficacy of tension-free vaginal tape with other pelvic reconstructive surgery. Am J Obstet Gynecol. 2002 Jun;186(6):1292-5; discussion 1295-8. doi: 10.1067/mob.2002.123736.
PubMed 12066111Barber MD, Kleeman S, Karram MM, Paraiso MF, Walters MD, Vasavada S, Ellerkmann M. Transobturator tape compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2008 Mar;111(3):611-21. doi: 10.1097/AOG.0b013e318162f22e.
PubMed 18310363Geller EJ. Prevention and management of postoperative urinary retention after urogynecologic surgery. Int J Womens Health. 2014 Aug 28;6:829-38. doi: 10.2147/IJWH.S55383. eCollection 2014.
PubMed 25210477Geller 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 21860294de Souza GM, Costa WS, Bruschini H, Sampaio FJ. Morphological analysis of the acute effects of overdistension on the extracellular matrix of the rat urinary bladder wall. Ann Anat. 2004 Feb;186(1):55-9. doi: 10.1016/S0940-9602(04)80122-5.
PubMed 14994912Rosseland LA, Stubhaug A, Breivik H. Detecting postoperative urinary retention with an ultrasound scanner. Acta Anaesthesiol Scand. 2002 Mar;46(3):279-82. doi: 10.1034/j.1399-6576.2002.t01-1-460309.x.
PubMed 11939918Asimakopoulos AD, De Nunzio C, Kocjancic E, Tubaro A, Rosier PF, Finazzi-Agro E. Measurement of post-void residual urine. Neurourol Urodyn. 2016 Jan;35(1):55-7. doi: 10.1002/nau.22671. Epub 2014 Sep 22.
PubMed 25251215Wheeler TL 2nd, Richter HE, Greer WJ, Bowling CB, Redden DT, Varner RE. Predictors of success with postoperative voiding trials after a mid urethral sling procedure. J Urol. 2008 Feb;179(2):600-4. doi: 10.1016/j.juro.2007.09.080. Epub 2007 Dec 21.
PubMed 18082219Hakvoort RA, Dijkgraaf MG, Burger MP, Emanuel MH, Roovers JP. Predicting short-term urinary retention after vaginal prolapse surgery. Neurourol Urodyn. 2009;28(3):225-8. doi: 10.1002/nau.20636.
PubMed 19130599Ripperda CM, Kowalski JT, Chaudhry ZQ, Mahal AS, Lanzer J, Noor N, Good MM, Hynan LS, Jeppson PC, Rahn DD. Predictors of early postoperative voiding dysfunction and other complications following a midurethral sling. Am J Obstet Gynecol. 2016 Nov;215(5):656.e1-656.e6. doi: 10.1016/j.ajog.2016.06.010. Epub 2016 Jun 16.
PubMed 27319367Kleeman S, Goldwasser S, Vassallo B, Karram M. Predicting postoperative voiding efficiency after operation for incontinence and prolapse. Am J Obstet Gynecol. 2002 Jul;187(1):49-52. doi: 10.1067/mob.2002.124841.
PubMed 12114887Foster 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 18060956Saint S. Clinical and economic consequences of nosocomial catheter-related bacteriuria. Am J Infect Control. 2000 Feb;28(1):68-75. doi: 10.1016/s0196-6553(00)90015-4.
PubMed 10679141Dieter AA, Amundsen CL, Visco AG, Siddiqui NY. Treatment for urinary tract infection after midurethral sling: a retrospective study comparing patients who receive short-term postoperative catheterization and patients who pass a void trial on the day of surgery. Female Pelvic Med Reconstr Surg. 2012 May-Jun;18(3):175-8. doi: 10.1097/SPV.0b013e3182544e03.
PubMed 22543772
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Spontaneous Trial of Void: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04010656
- Acronym / sponsor ID
- OPTION / WIH IRB 1145237
- Conditions
- Urinary Retention Postoperative, Voiding Disorders
- Keywords
- Urogynecologic surgery, Urinary retention postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Collaborators
- American Urogynecologic Society, American Association of Gynecologic Laparoscopists
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 10 May 2021 (actual)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 8 Jul 2019 (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.
Trial of void (TOV) is a diagnostic test performed on all women who undergo prolapse repair or incontinence surgery, due to the importance of diagnosing postoperative urinary retention (POUR). Incidence of POUR may be as high as 62% in some studies. Timely and accurate diagnosis is important to avoid complications such as urinary tract infection, bladder overdistension, and permanent bladder injury. Despite the frequent use of TOV, there is no gold standard for the test, and it likely has poor specificity, leading to discharge of more patients with catheter than required. This prospective cohort study will seek to establish evidence-based optimal parameters for spontaneous trial of void, a TOV modality that has merit for further evaluation given lower theoretical risk of urinary tract infection.
Detailed description
Patients will learn to perform self-catheterization ('clean intermittent catheterization', or CIC) preoperatively; after surgery, the investigators will collect a range of voiding parameters used during different TOV protocols (including minimum voided volume [MVV], post-void residual via bladder scanner [PVR], subjective force of urinary stream [sFOS]). Patients will discharge home to perform CIC until two sequential post-void residuals of less than half the volume voided have been achieved. The rate of voiding dysfunction and resulting PVRs will be used to compare the diagnostic accuracy of the perioperative voiding parameters to predict need to perform CIC and post-operative urinary retention.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will be taught to perform self-catheterization prior to prolapse repair or incontinence surgery; voiding data will be collected on the participant's first void after surgery. Participants will be discharged home to perform self-catheterization until post-void residual is less than half the volume voided on 2 sequential voids to assess actual voiding function, and this data will be used to calculate the diagnostic accuracy of pre-determined combinations of the TOV parameters.
| Arm | Type | Receives |
|---|---|---|
| PVR-based home self-catheterization | Experimental | Procedure: PVR-based self-catheterizationPatients will learn to self-catheterize preoperatively prior to urogynecology surgery requiring trial of void. First post-operative void will be used to collect basic information about voiding function. All participants will leave the hospital and self-catheterize until they achieve two sequential voids with post-void residual (PVR) less than half the volume voided. The cases of urinary retention captured with abnormal PVR will be used to compare the diagnostic accuracy of several commonly-used, pre-defined parameters for trial of void. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English-speaking women, age >18yo
- Scheduled for urogynecology procedure which will need post-operative trial of void (including pelvic organ prolapse and/or stress urinary incontinence repair), with plan for same-day discharge.
Key exclusion criteria (4 listed)
- Unable or unwilling to perform self-catheterizatoin either by patient or willing family member
- Pre-existing voiding dysfunction defined as documented PVR > 200 mL
- Intraoperative urinary tract injury needing indwelling catheter on discharge
- Need for overnight admission
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 |
|---|---|---|
| PVR-based self-catheterizationHome self-catheterization based on standard of care | Procedure or surgery | PVR-based home self-catheterization |
Primary outcome
Incidence of post-operative urinary retention
Time frame: 24-72 hours postoperative
Based on defined criteria
Diagnostic accuracy of trial of void parameters
Time frame: First void postoperative (within 4 hours postop)
Comparison of sensitivity, specificity, positive/negative predictive value of different trial of void parameters from first postoperative void, based on those used in the literature.
4 secondary outcomes
Rate of post-operative and post-discharge urinary retention
Time frame: 24-72 hours postoperative
Rate of post-operative urinary tract infection
Time frame: 6 weeks postoperative
Patient satisfaction with self-catheterization method via questionnaire
Time frame: 2 weeks postoperative
Time to first void postoperative
Time frame: 4 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Background: PubMed 11547032Dorflinger A, Monga A. Voiding dysfunction. Curr Opin Obstet Gynecol. 2001 Oct;13(5):507-12. doi: 10.1097/00001703-200110000-00010.
- Background: PubMed 12066111Partoll LM. Efficacy of tension-free vaginal tape with other pelvic reconstructive surgery. Am J Obstet Gynecol. 2002 Jun;186(6):1292-5; discussion 1295-8. doi: 10.1067/mob.2002.123736.
- Background: PubMed 18310363Barber MD, Kleeman S, Karram MM, Paraiso MF, Walters MD, Vasavada S, Ellerkmann M. Transobturator tape compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2008 Mar;111(3):611-21. doi: 10.1097/AOG.0b013e318162f22e.
- Background: PubMed 25210477Geller EJ. Prevention and management of postoperative urinary retention after urogynecologic surgery. Int J Womens Health. 2014 Aug 28;6:829-38. doi: 10.2147/IJWH.S55383. eCollection 2014.
- 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 14994912de Souza GM, Costa WS, Bruschini H, Sampaio FJ. Morphological analysis of the acute effects of overdistension on the extracellular matrix of the rat urinary bladder wall. Ann Anat. 2004 Feb;186(1):55-9. doi: 10.1016/S0940-9602(04)80122-5.
- Background: PubMed 11939918Rosseland LA, Stubhaug A, Breivik H. Detecting postoperative urinary retention with an ultrasound scanner. Acta Anaesthesiol Scand. 2002 Mar;46(3):279-82. doi: 10.1034/j.1399-6576.2002.t01-1-460309.x.
- Background: PubMed 25251215Asimakopoulos AD, De Nunzio C, Kocjancic E, Tubaro A, Rosier PF, Finazzi-Agro E. Measurement of post-void residual urine. Neurourol Urodyn. 2016 Jan;35(1):55-7. doi: 10.1002/nau.22671. Epub 2014 Sep 22.
- Background: PubMed 18082219Wheeler TL 2nd, Richter HE, Greer WJ, Bowling CB, Redden DT, Varner RE. Predictors of success with postoperative voiding trials after a mid urethral sling procedure. J Urol. 2008 Feb;179(2):600-4. doi: 10.1016/j.juro.2007.09.080. Epub 2007 Dec 21.
- Background: PubMed 19130599Hakvoort RA, Dijkgraaf MG, Burger MP, Emanuel MH, Roovers JP. Predicting short-term urinary retention after vaginal prolapse surgery. Neurourol Urodyn. 2009;28(3):225-8. doi: 10.1002/nau.20636.
- Background: PubMed 27319367Ripperda CM, Kowalski JT, Chaudhry ZQ, Mahal AS, Lanzer J, Noor N, Good MM, Hynan LS, Jeppson PC, Rahn DD. Predictors of early postoperative voiding dysfunction and other complications following a midurethral sling. Am J Obstet Gynecol. 2016 Nov;215(5):656.e1-656.e6. doi: 10.1016/j.ajog.2016.06.010. Epub 2016 Jun 16.
- Background: PubMed 12114887Kleeman S, Goldwasser S, Vassallo B, Karram M. Predicting postoperative voiding efficiency after operation for incontinence and prolapse. Am J Obstet Gynecol. 2002 Jul;187(1):49-52. doi: 10.1067/mob.2002.124841.
- 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.
Anne C Cooper, MD, MA principal investigator
Dartmouth-Hitchcock Medical Center, Lebanon NH
Julia Shinnick, MD principal investigator
Women & Infants Hospital, Providence RI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVR-based self-catheterization in people with Urinary Retention Postoperative and Voiding Disorders, run by Women and Infants Hospital of Rhode Island 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 2 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 20 Jul 2021. 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?
Results are not available in the source record.
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?
Incidence of post-operative urinary retention (time frame: 24-72 hours postoperative). The study lists 2 primary outcomes in all. 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 NCT04010656, which also lists 30 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 20 Jul 2021.