Clinical trial NCT02443987: Time Interval Between TVT and First Void (TIBT) Study
Official title: Time Interval Between TVT and First Void (TIBT) Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Tension-Free Vaginal Tape
Lead sponsor: Gloucestershire Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2015-05-14
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time interval between end of surgery and first void
timeFrame: 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 outcomes:
measure: Length of time to discharge (from end of surgery to when the patient is fit for discharge)
timeFrame: 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)
measure: Patient satisfaction using patient questionnaire
timeFrame: 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)
measure: Number of patient's requiring in-out catheterisation due to difficulty voiding
timeFrame: 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)
Other outcomes:
Locations:
Study officials:
affiliation: Gloucestershire Hospitals NHS Foundation Trust
name: Mark James, MBChB MD
role: PRINCIPAL_INVESTIGATOR
References: