Trial Outcomes & Findings for Time Interval Between TVT and First Void (TIBT) Study (NCT NCT02443987)
NCT ID: NCT02443987
Last Updated: 2025-10-29
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
43 participants
Primary outcome 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)
Results posted on
2025-10-29
Participant Flow
Recruitment from October 2015 to June 2016. Recruited from urogynaecology clinic on decision to add to TVT waiting list.
3 Patient's operations were cancelled by the surgeon or the patient prior to randomisation.
Participant milestones
| Measure |
Received intravenous fluids
The patient received 500ml of 0.9% sodium chloride fluid intravenously during the operation.
|
Control Arm
The patient received no intravenous fluid as per current routine protocol
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
20
|
|
Overall Study
COMPLETED
|
22
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Received intravenous fluids
The patient received 500ml of 0.9% sodium chloride fluid intravenously during the operation.
|
Control Arm
The patient received no intravenous fluid as per current routine protocol
|
|---|---|---|
|
Overall Study
Bladder injury
|
1
|
1
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Received intravenous fluids
n=22 Participants
The patient received 500ml of 0.9% sodium chloride fluid intravenously during the operation.
|
Control Arm
n=18 Participants
The patient received no intravenous fluid as per current routine protocol
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 years or above
|
22 Participants
n=22 Participants
|
18 Participants
n=18 Participants
|
40 Participants
n=40 Participants
|
|
Sex/Gender, Customized
Female
|
22 Participants
n=22 Participants
|
18 Participants
n=18 Participants
|
40 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
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)Outcome measures
| Measure |
Received intravenous fluids
n=22 Participants
The patient received 500ml of 0.9% sodium chloride fluid intravenously during the operation.
|
Control Arm
n=18 Participants
The patient received no intravenous fluid as per current routine protocol
|
|---|---|---|
|
Time Interval Between End of Surgery and First Void
|
183 minutes
Interval 30.0 to 420.0
|
197 minutes
Interval 90.0 to 290.0
|
SECONDARY outcome
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)Volume of urine passed at first void
Outcome measures
| Measure |
Received intravenous fluids
n=22 Participants
The patient received 500ml of 0.9% sodium chloride fluid intravenously during the operation.
|
Control Arm
n=18 Participants
The patient received no intravenous fluid as per current routine protocol
|
|---|---|---|
|
Volume of Urine Passed
|
269 mL
Interval 21.0 to 600.0
|
199 mL
Interval 62.0 to 600.0
|
SECONDARY outcome
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)Residual volume of urine left in the bladder after first void as measured by bladder scanning
Outcome measures
| Measure |
Received intravenous fluids
n=22 Participants
The patient received 500ml of 0.9% sodium chloride fluid intravenously during the operation.
|
Control Arm
n=18 Participants
The patient received no intravenous fluid as per current routine protocol
|
|---|---|---|
|
Residual Volume in Bladder
|
141 mL
Interval 0.0 to 652.0
|
42 mL
Interval 0.0 to 220.0
|
SECONDARY outcome
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)Time interval between end of surgery to when staff deem patient is fit for discharge.
Outcome measures
| Measure |
Received intravenous fluids
n=22 Participants
The patient received 500ml of 0.9% sodium chloride fluid intravenously during the operation.
|
Control Arm
n=18 Participants
The patient received no intravenous fluid as per current routine protocol
|
|---|---|---|
|
Time to "Fit for Discharge"
|
355 minutes
Interval 135.0 to 1443.0
|
339 minutes
Interval 175.0 to 945.0
|
SECONDARY outcome
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)Outcome measures
| Measure |
Received intravenous fluids
n=22 Participants
The patient received 500ml of 0.9% sodium chloride fluid intravenously during the operation.
|
Control Arm
n=18 Participants
The patient received no intravenous fluid as per current routine protocol
|
|---|---|---|
|
Number of Patient's Requiring In-out Catheterisation Due to Difficulty Voiding
|
2 Participants
|
0 Participants
|
SECONDARY outcome
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)Population: 2 patients did not return a completed satisfaction 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.
Outcome measures
| Measure |
Received intravenous fluids
n=21 Participants
The patient received 500ml of 0.9% sodium chloride fluid intravenously during the operation.
|
Control Arm
n=17 Participants
The patient received no intravenous fluid as per current routine protocol
|
|---|---|---|
|
Patient Satisfaction Using Patient Questionnaire
Satisfaction with explanation
|
9.9 units on a scale
Interval 9.0 to 10.0
|
9.9 units on a scale
Interval 9.0 to 10.0
|
|
Patient Satisfaction Using Patient Questionnaire
Anxiety before
|
6.5 units on a scale
Interval 1.0 to 10.0
|
5.6 units on a scale
Interval 0.0 to 10.0
|
|
Patient Satisfaction Using Patient Questionnaire
Rating of support from staff during the procedure
|
9.9 units on a scale
Interval 8.0 to 10.0
|
9.8 units on a scale
Interval 8.0 to 10.0
|
|
Patient Satisfaction Using Patient Questionnaire
Satisfaction with privacy and dignity
|
10.0 units on a scale
Interval 10.0 to 10.0
|
9.8 units on a scale
Interval 7.0 to 10.0
|
|
Patient Satisfaction Using Patient Questionnaire
Satisfaction with length of stay
|
9.0 units on a scale
Interval 4.0 to 10.0
|
9.8 units on a scale
Interval 9.0 to 10.0
|
|
Patient Satisfaction Using Patient Questionnaire
Satisfied with explanation of discomfort
|
9.4 units on a scale
Interval 7.0 to 10.0
|
9.7 units on a scale
Interval 7.0 to 10.0
|
|
Patient Satisfaction Using Patient Questionnaire
Satisfaction with length of time to first void
|
8.3 units on a scale
Interval 2.0 to 10.0
|
8.7 units on a scale
Interval 4.0 to 10.0
|
|
Patient Satisfaction Using Patient Questionnaire
Overall satisfaction with procedure
|
9.7 units on a scale
Interval 8.0 to 10.0
|
9.9 units on a scale
Interval 9.0 to 10.0
|
Adverse Events
Received intravenous fluids
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control Arm
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Received intravenous fluids
n=23 participants at risk
The patient will receive 500ml of 0.9% NaCl fluid intravenously during the operation.
Intravenous fluid: 500ml infusion of 0.9% Sodium Chloride intravenously.
|
Control Arm
n=20 participants at risk
The patient will receive no intravenous fluid as per current routine protocol
|
|---|---|---|
|
Renal and urinary disorders
Bladder injury
|
4.3%
1/23 • Adverse event data collected over 1 month post surgery.
|
5.0%
1/20 • Adverse event data collected over 1 month post surgery.
|
Additional Information
Dr Sharan Athwal
Gloucestershire Hospitals NHS Foundation Trust
Phone: 0300 422 2222
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place