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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Received intravenous fluids | Experimental | The patient will receive 500ml of 0.9% NaCl fluid intravenously during the operation. |
|
| Control Arm | No Intervention | The patient will receive no intravenous fluid as per current routine protocol |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous fluid | Other | 500ml infusion of 0.9% Sodium Chloride intravenously. |
|
| Measure | Description | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Volume of Urine Passed | Volume of urine passed at 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) |
| Residual Volume in Bladder |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark James, MBChB MD | Gloucestershire Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gloucestershire Royal Hospital | Gloucester | GL1 3NN | United Kingdom | |||
| Stroud General Hospital |
3 Patient's operations were cancelled by the surgeon or the patient prior to randomisation.
Recruitment from October 2015 to June 2016. Recruited from urogynaecology clinic on decision to add to TVT waiting list.
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| ID | Title | Description |
|---|---|---|
| FG000 | Received intravenous fluids | The patient received 500ml of 0.9% sodium chloride fluid intravenously during the operation. |
| FG001 | Control Arm | The patient received no intravenous fluid as per current routine protocol |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Received intravenous fluids | The patient received 500ml of 0.9% sodium chloride fluid intravenously during the operation. |
| BG001 | Control Arm | The patient received no intravenous fluid as per current routine protocol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time Interval Between End of Surgery and First Void | Posted | Mean | Full Range | minutes | 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) |
|
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Adverse event data collected over 1 month post surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Received intravenous fluids | The patient will receive 500ml of 0.9% NaCl fluid intravenously during the operation. Intravenous fluid: 500ml infusion of 0.9% Sodium Chloride intravenously. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bladder injury | Renal and urinary disorders | Bladder injury at time of surgery - related to the surgery and not directly due to study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Sharan Athwal | Gloucestershire Hospitals NHS Foundation Trust | 0300 422 2222 | sharan.athwal@glos.nhs.uk |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Residual volume of urine left in the bladder after first void as measured by bladder scanning
| 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 to "Fit for Discharge" | Time interval between end of surgery to when staff deem patient is 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) |
| 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 | 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. | 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) |
| Stroud |
| GL5 2HY |
| United Kingdom |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Participants |
|
|
|
| Secondary | Volume of Urine Passed | Volume of urine passed at first void | Posted | Mean | Full Range | mL | 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 | Residual Volume in Bladder | Residual volume of urine left in the bladder after first void as measured by bladder scanning | Posted | Mean | Full Range | mL | 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 | Time to "Fit for Discharge" | Time interval between end of surgery to when staff deem patient is fit for discharge. | Posted | Mean | Full Range | minutes | 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 | Number of Patient's Requiring In-out Catheterisation Due to Difficulty Voiding | Posted | Count of Participants | Participants | 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 | 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. | 2 patients did not return a completed satisfaction questionnaire. | Posted | Mean | Full Range | units on a scale | 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) |
|
|
|
| 0 |
| 23 |
| 1 |
| 23 |
| EG001 | Control Arm | The patient will receive no intravenous fluid as per current routine protocol | 0 | 20 | 1 | 20 |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Satisfied with explanation of discomfort |
|
| Rating of support from staff during the procedure |
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| Satisfaction with privacy and dignity |
|
| Satisfaction with length of stay |
|
| Satisfaction with length of time to first void |
|
| Overall satisfaction with procedure |
|