Time Interval Between TVT and First Void (TIBT) Study

Not Applicable

Completed

Conditions: Stress Urinary Incontinence

Registration Number: NCT02443987

Lead Sponsor: Gloucestershire Hospitals NHS Foundation Trust

Brief Summary: The primary aim of this study is to compare, in women undergoing tension-free vaginal tape (TVT) insertion under sedation and local anaesthetic infiltration, the time interval of first void following surgery between a group of patients who received intravenous fluids to those who did not.

Detailed Description: Urinary incontinence is a global condition and its prevalence increases with age. It impairs quality of life of patients and has a significant burden on the health care system. Stress urinary incontinence (SUI) is defined as involuntary leakage of urine when there is an increase in pressure on the bladder, i.e. during exercise, coughing or sneezing. It is the commonest form of urinary incontinence and affects around 50% of women with symptoms of incontinence.

The development of mid urethral tapes (e.g. the tension free vaginal tape \[TVT\]) in 1998 has greatly changed clinical practice. The introduction of TVTs has reduced the average length of hospital stay for patients undergoing surgical treatment of SUI by over 50%. As a result, the hospital bed occupancy for the treatment of SUI has decreased by a similar amount. Studies have shown it to have similar effectiveness to the main alternative surgical treatments in SUI.

In Gloucestershire Royal Hospital, we perform the procedure as a daycase with local anaesthetic infiltration under sedation. Routine cystoscopy is performed as a part of the procedure to exclude bladder trauma. The bladder is emptied at the end of procedure. Patients are then allowed to drink as normal and post void residuals are checked before discharge to rule out any problems emptying the bladder. It has been observed that the major limiting factor in early discharge of patients is the time to first void following surgery. As the patients are starved for surgery, they are often dehydrated and therefore require enough oral fluids to rehydrate and fill their bladder in order to void. If we can somehow reduce this waiting period, we can discharge patients sooner improving their experience with the surgery. We would like to examine whether filling up the bladder intra-operatively with intravenous fluid will reduce this time limiting step.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 43

Inclusion Criteria

Participant is willing and able to give informed consent for participation in the study

Exclusion Criteria

TVT performed under general or spinal anaesthetic
Women under the age of 18 years
Women unable to give informed consent
TVT performed in addition to another procedure
Women not suitable for a fluid challenge due to co-morbidities.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time Interval Between End of Surgery and First Void	The participants will be followed for the duration of hospital stay, which is expected to be an average of 6 hours (and no longer than 24 hours)

Secondary Outcome Measures

Name	Time	Method
Volume of Urine Passed	The participants will be followed for the duration of hospital stay, which is expected to be an average of 6 hours (and no longer than 24 hours)	Volume of urine passed at first void
Residual Volume in Bladder	The participants will be followed for the duration of hospital stay, which is expected to be an average of 6 hours (and no longer than 24 hours)	Residual volume of urine left in the bladder after first void as measured by bladder scanning
Time to "Fit for Discharge"	The participants will be followed for the duration of hospital stay, which is expected to be an average of 6 hours (and no longer than 24 hours)	Time interval between end of surgery to when staff deem patient is fit for discharge.
Number of Patient's Requiring In-out Catheterisation Due to Difficulty Voiding	The participants will be followed for the duration of hospital stay, which is expected to be an average of 6 hours (and no longer than 24 hours)
Patient Satisfaction Using Patient Questionnaire	The participants will be followed for the duration of hospital stay, which is expected to be an average of 6 hours (and no longer than 24 hours)	Patients were asked to grade their experience using a series of questions. They were asked to answer each on a scale of 0 to 10 in terms of satisfaction, with 0 = not at all and 10 = extremely (numbers 1-9 were not classified). Therefore the higher the score the more positive the patient experience.

Trial Locations

Locations (2): Gloucestershire Royal Hospital
🇬🇧
Gloucester, United Kingdom
Stroud General Hospital
🇬🇧
Stroud, United Kingdom
Gloucestershire Royal Hospital
🇬🇧Gloucester, United Kingdom