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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]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

urodynamic stress incontinence

post surgery (midurethral sling procedure)

Condition category

Condition code

Surgery

Other surgery

Renal and Urogenital

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]

Treatment: Surgery

Intervention code [2]

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]

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]

within 2 hours of surgery (usually within 4 hours of randomization)

Secondary outcome [1]

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]

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]

Requirement for catheterisation post operatively.

Timepoint [2]

10 days

Secondary outcome [3]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Robina Hospital - Robina

Recruitment postcode(s) [1]

4226 - Robina

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Robina Hospital

Address [1]

2 Bayberry Ln, Robina QLD 4226

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Gold Coast Hospital

Ethics committee address [1]

Clinical Governance, Education and Research
Level 2 Block E Gold Coast University Hospital
1 Hospital Boulevard
Southport QLD 4215

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/08/2014

Approval date [1]

21/10/2014

Ethics approval number [1]

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]

/AnzctrAttachments/371950-HREC approval.pdf (Ethics approval)

Contacts

Principal investigator

Name

Dr Alex Mowat

Address

Royal Brisbane and Women's Hopspital
Butterfield St & Bowen Bridge Rd, Herston QLD 4029

Country

Australia

Phone

+61 404303334

Fax

zanhmowat@gmail.com

Contact person for public queries

Name

Alex Mowat

Address

Royal Brisbane and Women's Hospital
Butterfield St & Bowen Bridge Rd, Herston QLD 4029

Country

Australia

Phone

+61 404303334

Fax

zanhmowat@gmail.com

Contact person for scientific queries

Name

Alex Mowat

Address

Royal Brisbane and Women's Hospital
Butterfield St & Bowen Bridge Rd, Herston QLD 4029

Country

Australia

Phone

+61 404303334

Fax

zanhmowat@gmail.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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