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: Unknown
• 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 (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sharan Athwal, BM BCh; Email: sharan.athwal@gmail.com
• Study Contact Backup: Name: Mark James, MBChB MD; Email: mark.james@glos.nhs.uk

Participation Criteria

Eligibility Criteria

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

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

• 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	Time Frame
Length of time to discharge (from end of surgery to when the 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)
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)
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)

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: May 1, 2015
• Primary Completion (Anticipated): November 1, 2015
• Study Completion (Anticipated): November 1, 2015

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Estimate): May 14, 2015
• Last Update Submitted That Met QC Criteria: May 11, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Tension-Free Vaginal Tape
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Incontinence, Stress
• Other Study ID Numbers: 15/013/GHT