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Trial registered on ANZCTR


Registration number
ACTRN12616001734459
Ethics application status
Approved
Date submitted
30/11/2016
Date registered
16/12/2016
Date last updated
16/12/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Infusion method vs. standard auto-fill trial of void following a tension free vaginal tape (TVT-exact) procedure in women with urodynamic stress incontinence
Scientific title
Effect of infusion method vs. standard auto-fill trial of void following a tension free vaginal tape (TVT-exact) procedure on time to discharge in women with urodynamic stress incontinence
Secondary ID [1] 290657 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
urodynamic stress incontinence 301183 0
post surgery (midurethral sling procedure) 301184 0
Condition category
Condition code
Surgery 300938 300938 0 0
Other surgery
Renal and Urogenital 301092 301092 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After routine surgery instead of emptying bladder and sending patient to ward for trial of void, we will fill bladder with 200ml normal saline (called infusion method) and perform trial of void in recovery.
The intervention takes place once the entire surgical procedure is finished. The last part of the procedure is cystoscopy. After the bladder is emptied via the cystoscope, 200ml of normal saline with by infused back into bladder (infusion method).
Intervention code [1] 296536 0
Treatment: Surgery
Intervention code [2] 296656 0
Treatment: Other
Comparator / control treatment
the control group is women who undergo the standard auto-fill trial of void method. This means that the women have their bladders emptied at the end of the procedure via cystoscopy and undergo their trial of void on the ward.
Control group
Active

Outcomes
Primary outcome [1] 300359 0
The primary outcome is discharge home from the recovery area. The primary outcome is not the actual time taken to pass trial of void. It is whether the women are discharged home from recovery so we want to know what percentage go home from recovery with each method of trial of void. We want to establish if the infusion method will result in a higher proportion of women going home from recovery.
Patients who initially fail their trial of void in the 2 hours may go on to pass it on the ward within 24 hours (most do). If they continued to fail their trial of void, they are either sent home with an indwelling catheter or they are taught to self catheterise (more common). Catherisation is continued until bladder function normalises.
For discharge from recover to be achieved the woman must have successfully passed the trial of void (TOV)
A successful TOV for the purposes of this trial is defined as follows:
A SINGLE void of greater than or equal to 2/3 of total bladder volume
i.e. volume voided/(volume voided + post void residual) is more than 68%.

This will be determined by measuring volume of urine voided and then using a bladder scanner to measure the volume of the post void residual.
Timepoint [1] 300359 0
within 2 hours of surgery (usually within 4 hours of randomization)
Secondary outcome [1] 329776 0
time taken to achieve a successful trial of void.
A successful TOV for the purposes of this trial is defined as follows:
A SINGLE void of greater than 2/3 of total bladder volume
i.e. volume voided/(volume voided + post void residual) is more than68%.

This will be determined by measuring volume of urine voided and then using a bladder scanner to measure the volume of the post void residual.
Timepoint [1] 329776 0
The timepoint for this is variable. If patients initially fail their TOV they go home with a catheter and are brought back between 2 days to 1 week to repeat their TOV
Assessment of the length of time they took to pass their TOV will occur a 6 weeks after randomisation.
Secondary outcome [2] 330163 0
Requirement for catheterisation post operatively.
Timepoint [2] 330163 0
10 days
Secondary outcome [3] 330176 0
successful trial of void (eventually). This is a dichotomous outcome. It is assessed by the formal trial of void process. It requires clinician assessment that voiding is adequate by measuring volume voided with a measuring jug and post void residual with a bladder scanner. If initial trial of void is failed, most clinicians would consider 2 consecutive succsssful voids at defined previously as adequate for a successful trial of void. There is some clinician discretion involved but ultimately it is a question of whether the patient can successful void.
Timepoint [3] 330176 0
6 week follow up

Eligibility
Key inclusion criteria
Any woman consented for a mid urethral sling procedure at Robina Hospital.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with urodynamic study proven detrusor overactivity, mixed urinary incontinence or voiding dysfunction.
Preoperative postvoid residual of >150ml
Patients who cannot be booked as a day case i.e. patients with a medical or social reason preventing discharge on the day of operation.
Epidural/spinal anaesthesia
Neurological conditions affecting the lower urinary tract
Bladder perforation at the time of TVT placement or other incidental pathologies diagnosed at time of surgery such as interstitial cystitis, malignancy or calculi.
Patients undergoing any other concomitant procedure.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involved contacting the holder of the allocation schedule who will be responsible for assigning randomisation according to the computer generated sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated block
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Intention to treat analysis will be used.
Dichotomous and categorical data will be analysed using the chi-square test and continuous data will be analysed using the student t-test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/01/2016
Date of last participant enrolment
Anticipated
31/01/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7011 0
Robina Hospital - Robina
Recruitment postcode(s) [1] 14743 0
4226 - Robina

Funding & Sponsors
Funding source category [1] 295087 0
Hospital
Name [1] 295087 0
Robina Hospital
Country [1] 295087 0
Australia
Primary sponsor type
Individual
Name
Dr Alex Mowat
Address
Royal Brisbane and Women's Hospital
Butterfield St & Bowen Bridge Rd, Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 293907 0
None
Name [1] 293907 0
Address [1] 293907 0
Country [1] 293907 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296528 0
Gold Coast Hospital
Ethics committee address [1] 296528 0
Clinical Governance, Education and Research
Level 2 Block E Gold Coast University Hospital
1 Hospital Boulevard
Southport QLD 4215
Ethics committee country [1] 296528 0
Australia
Date submitted for ethics approval [1] 296528 0
13/08/2014
Approval date [1] 296528 0
21/10/2014
Ethics approval number [1] 296528 0
HREC/14/QGC/151

Summary
Brief summary
Aim
The aim of the study was to determine length of time from tension-free vaginal tape procedure to discharge can be shortened by using the infusion method trial of void rather than the standard auto-fill trial of void.

Background
Tension free vaginal tape (TVT-exact) procedure is a commonly performed continence procedure for urodynamic stress incontinence. At present, prior to discharge home, standard practice at our institution requires completion of a trial of void (TOV). Protocols differ between institutions, but generally a TOV requires overnight admission.
However in some centres, it is routine practice to send patients home within 2 hours of the operation if they have passed urine. The nature of the surgery does not require patients to undergo an extended period of observation.

Currently, our practice is to empty each patient’s bladder upon completion of surgery. The time to initial void is then dependent on the rate of urine production for each patient. This process is termed “auto-fill”. The alternative method is called the “infusion” method, where the bladder is filled with a predefined volume at completion of surgery to facilitate a shorter time until first postoperative void.

The infusion method has been studied in several trials and is safe for patients and effective at predicting which patients will have post-operative voiding dysfunction in gynaecology patients. (Kleeman S, Goldwassar S, Vassallo B. Predicting postoperative voiding efficacy after operation for incontinence and prolapse. Am J Obstet Gynecol 2002;187:49, Pulvino JQ, Duecy EE, Buchsbaum GM, Flynn MK. Comparison of 2 Techniques to Predict Voiding Efficiency After Inpatient Urogynecologic Surgery. J Urol 2010;184:1408)
However these studies are not powered to find a significant difference in time to complete TOV.

The TOV process will begin in the recovery area of theatre. If the patient passes the TOV within 2 hours and they are otherwise well, they will be discharged home from recovery. If they have not passed their TOV within 2 hours, they will be transferred to the ward for continuation of the process.
Recovery and ward nurses assessing the TOVs will be blinded as to which group the patient belongs to. Unlike previous studies, patients will also be blinded as to which group they have been allocated to.

Inclusion Criteria
Patients consented to undergo a TVT-exact procedure at Robina Hospital.

Exclusion Criteria
Patients with urodynamic study proven detrusor overactivity, mixed urinary incontinence or voiding dysfunction.
Preoperative postvoid residual of >150ml
Patients who cannot be booked as a day case i.e. patients with a medical or social reason preventing discharge on the day of operation.
Epidural/spinal anaesthesia
Neurological conditions affecting the lower urinary tract
Bladder perforation at the time of TVT placement or other incidental pathologies diagnosed at time of surgery such as interstitial cystitis, malignancy or calculi.
Patients undergoing any other concomitant procedure.

Primary Outcome
Discharge within 2 hours of the end of the operation.

Secondary Outcomes
Time taken to complete trial of void
Successful trial of void
Continued self catheterisation or in-dwelling catheterisation beyond ten days post operation

Follow up
1. 2 week gynaecology outpatient appointment to confirm absence of voiding dysfunction: a post void residual with a bladder scanner
2. Routine 6 week postoperative appointment.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1277 1277 0 0
/AnzctrAttachments/371950-HREC approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 70858 0
Dr Alex Mowat
Address 70858 0
Royal Brisbane and Women's Hopspital
Butterfield St & Bowen Bridge Rd, Herston QLD 4029
Country 70858 0
Australia
Phone 70858 0
+61 404303334
Fax 70858 0
Email 70858 0
[email protected]
Contact person for public queries
Name 70859 0
Alex Mowat
Address 70859 0
Royal Brisbane and Women's Hospital
Butterfield St & Bowen Bridge Rd, Herston QLD 4029
Country 70859 0
Australia
Phone 70859 0
+61 404303334
Fax 70859 0
Email 70859 0
[email protected]
Contact person for scientific queries
Name 70860 0
Alex Mowat
Address 70860 0
Royal Brisbane and Women's Hospital
Butterfield St & Bowen Bridge Rd, Herston QLD 4029
Country 70860 0
Australia
Phone 70860 0
+61 404303334
Fax 70860 0
Email 70860 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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