Stress Urinary Incontinence
Conditions
Keywords
Tension-Free Vaginal Tape
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.
Interventions
OTHERIntravenous fluid
500ml infusion of 0.9% Sodium Chloride intravenously.
Sponsors
Gloucestershire Hospitals NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United Kingdom
Participant flow
Recruitment details
Recruitment from October 2015 to June 2016. Recruited from urogynaecology clinic on decision to add to TVT waiting list.
Pre-assignment details
3 Patient's operations were cancelled by the surgeon or the patient prior to randomisation.
Participants by arm
| Arm | Count |
|---|---|
| Received intravenous fluids The patient received 500ml of 0.9% sodium chloride fluid intravenously during the operation. | 22 |
| Control Arm The patient received no intravenous fluid as per current routine protocol | 18 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Bladder injury | 1 | 1 |
| Overall Study | Other | 0 | 1 |
Baseline characteristics
| Characteristic | Control Arm | Total | Received intravenous fluids |
|---|---|---|---|
| Age, Customized 18 years or above | 18 Participants | 40 Participants | 22 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex/Gender, Customized Female | 18 Participants | 40 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 23 | 1 / 20 |
| serious Total, serious adverse events | 0 / 23 | 0 / 20 |
Outcome results
Primary
Time Interval Between End of Surgery and First Void
Time frame: 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)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Received intravenous fluids | Time Interval Between End of Surgery and First Void | 183 minutes |
| Control Arm | Time Interval Between End of Surgery and First Void | 197 minutes |
p-value: 0.4Wilcoxon (Mann-Whitney)
Secondary
Number of Patient's Requiring In-out Catheterisation Due to Difficulty Voiding
Time frame: 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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Received intravenous fluids | Number of Patient's Requiring In-out Catheterisation Due to Difficulty Voiding | 2 Participants |
| Control Arm | Number of Patient's Requiring In-out Catheterisation Due to Difficulty Voiding | 0 Participants |
Secondary
Patient Satisfaction Using Patient Questionnaire
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.
Time frame: 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)
Population: 2 patients did not return a completed satisfaction questionnaire.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Received intravenous fluids | Patient Satisfaction Using Patient Questionnaire | Satisfaction with explanation | 9.9 units on a scale |
| Received intravenous fluids | Patient Satisfaction Using Patient Questionnaire | Anxiety before | 6.5 units on a scale |
| Received intravenous fluids | Patient Satisfaction Using Patient Questionnaire | Satisfied with explanation of discomfort | 9.4 units on a scale |
| Received intravenous fluids | Patient Satisfaction Using Patient Questionnaire | Rating of support from staff during the procedure | 9.9 units on a scale |
| Received intravenous fluids | Patient Satisfaction Using Patient Questionnaire | Satisfaction with privacy and dignity | 10.0 units on a scale |
| Received intravenous fluids | Patient Satisfaction Using Patient Questionnaire | Satisfaction with length of stay | 9.0 units on a scale |
| Received intravenous fluids | Patient Satisfaction Using Patient Questionnaire | Satisfaction with length of time to first void | 8.3 units on a scale |
| Received intravenous fluids | Patient Satisfaction Using Patient Questionnaire | Overall satisfaction with procedure | 9.7 units on a scale |
| Control Arm | Patient Satisfaction Using Patient Questionnaire | Overall satisfaction with procedure | 9.9 units on a scale |
| Control Arm | Patient Satisfaction Using Patient Questionnaire | Satisfaction with explanation | 9.9 units on a scale |
| Control Arm | Patient Satisfaction Using Patient Questionnaire | Satisfaction with privacy and dignity | 9.8 units on a scale |
| Control Arm | Patient Satisfaction Using Patient Questionnaire | Anxiety before | 5.6 units on a scale |
| Control Arm | Patient Satisfaction Using Patient Questionnaire | Satisfaction with length of time to first void | 8.7 units on a scale |
| Control Arm | Patient Satisfaction Using Patient Questionnaire | Satisfied with explanation of discomfort | 9.7 units on a scale |
| Control Arm | Patient Satisfaction Using Patient Questionnaire | Satisfaction with length of stay | 9.8 units on a scale |
| Control Arm | Patient Satisfaction Using Patient Questionnaire | Rating of support from staff during the procedure | 9.8 units on a scale |
Secondary
Residual Volume in Bladder
Residual volume of urine left in the bladder after first void as measured by bladder scanning
Time frame: 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)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Received intravenous fluids | Residual Volume in Bladder | 141 mL |
| Control Arm | Residual Volume in Bladder | 42 mL |
p-value: 0.02Wilcoxon (Mann-Whitney)
Secondary
Time to Fit for Discharge
Time interval between end of surgery to when staff deem patient is fit for discharge.
Time frame: 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)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Received intravenous fluids | Time to Fit for Discharge | 355 minutes |
| Control Arm | Time to Fit for Discharge | 339 minutes |
p-value: 0.51Wilcoxon (Mann-Whitney)
Secondary
Volume of Urine Passed
Volume of urine passed at first void
Time frame: 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)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Received intravenous fluids | Volume of Urine Passed | 269 mL |
| Control Arm | Volume of Urine Passed | 199 mL |
p-value: 0.18Wilcoxon (Mann-Whitney)