Time Interval Between TVT and First Void (TIBT) Study (TIBT)

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.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Other: Intravenous fluid

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Gloucester, United Kingdom, GL1 3NN
    • Gloucestershire Royal Hospital
  • Stroud, United Kingdom, GL5 2HY
    • Stroud General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Received intravenous fluids; The patient will receive 500ml of 0.9% NaCl fluid intravenously during the operation.	Other: Intravenous fluid; 500ml infusion of 0.9% Sodium Chloride intravenously.
No Intervention: Control Arm; The patient will receive no intravenous fluid as per current routine protocol

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Gloucestershire Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Mark James, MBChB MD, Gloucestershire Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: April 27, 2015
• First Submitted That Met QC Criteria: May 11, 2015
• First Posted (Estimated): May 14, 2015

Study Record Updates

• Last Update Posted (Estimated): October 29, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Tension-Free Vaginal Tape
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Incontinence; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence, Stress
• Other Study ID Numbers: 15/013/GHT