NCT02443987

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 14, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
9.3 years until next milestone

Results Posted

Study results publicly available

October 29, 2025

Completed
Last Updated

October 29, 2025

Status Verified

August 1, 2017

Enrollment Period

11 months

First QC Date

April 27, 2015

Results QC Date

April 12, 2017

Last Update Submit

September 30, 2025

Conditions

Stress Urinary Incontinence

Keywords

Tension-Free Vaginal Tape

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Volume of Urine Passed

    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

    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"

    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

    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)

Study Arms (2)

Received intravenous fluids

EXPERIMENTAL

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

Other: Intravenous fluid

Control Arm

NO INTERVENTION

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

Interventions

Intravenous fluidOTHER

500ml infusion of 0.9% Sodium Chloride intravenously.

Received intravenous fluids

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant is willing and able to give informed consent for participation in the study

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gloucestershire Royal Hospital

Gloucester, GL1 3NN, United Kingdom

Location

Stroud General Hospital

Stroud, GL5 2HY, United Kingdom

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr Sharan Athwal
Organization
Gloucestershire Hospitals NHS Foundation Trust
sharan.athwal@glos.nhs.uk
0300 422 2222

Study Officials

  • Mark James, MBChB MD

    Gloucestershire Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2015

First Posted

May 14, 2015

Study Start

August 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

October 29, 2025

Results First Posted

October 29, 2025

Record last verified: 2017-08

Locations

GB(2)