Time Interval Between TVT and First Void (TIBT) Study

NCT ID: NCT02443987

Last Updated: 2025-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-07-31

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.

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Received intravenous fluids

The patient will receive 500ml of 0.9% NaCl fluid intravenously during the operation.

Group Type: EXPERIMENTAL

Intravenous fluid

Intervention Type: OTHER

500ml infusion of 0.9% Sodium Chloride intravenously.

Control Arm

The patient will receive no intravenous fluid as per current routine protocol

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intravenous fluid

500ml infusion of 0.9% Sodium Chloride intravenously.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Gloucestershire Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark James, MBChB MD

Role: PRINCIPAL_INVESTIGATOR

Gloucestershire Hospitals NHS Foundation Trust

Locations

Gloucestershire Royal Hospital

Gloucester, , United Kingdom

Stroud General Hospital

Stroud, , United Kingdom

Countries

United Kingdom

Other Identifiers

15/013/GHT

Identifier Type: -

Identifier Source: org_study_id