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A prospective study on determining position of Tension Free Vaginal Tape – Obturator (TVT-O) by Ultrasonography and associated urinary symptom

What is the position of Tension Free Vaginal Tape – Obturator (TVT-O) determined by Ultrasonography and the associated post-operative urinary symptoms in Chinese Women with urodynamic stress incontinence?

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000263695
Enrollment
150
Registered
2014-03-11
Start date
2014-03-15
Completion date
2015-03-14
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is carried out in Department of Obstetrics and Gynaecology of Queen Elizabeth Hospital. We will try to recruit all women presented with Udodynamic stress incontinence with Tension free vaginal tape - obturator done for joining this study. Before the development of perineal ultrasound, the position of TVT-O is only determined by clinical experience and whether the post-operative voiding symptom is related or not is again determined by clinical experience. This study designed to determine the position of TVT-O at 3 and 6 months post-operatively and hence determine the associated urinary symptoms in order to study the relationship between the tape position and post-operative voiding symptoms.

Interventions

The recruited patient will have a transperineal ultrasound scan performed in order to determine the position of Tension Free Vaginal Tape - Obturator (TVT-O). This is a non-invasive procedure with no radiation exposure. The whole scan process will last for around 15 minutes. The recruited patient will have 2 scans after insertion of TVT-O treatment at post-operative 3rd and 6th months.

Sponsors

Chi Wai TUNG
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Age equal to or larger than 18 years old Mentally fit for written informed consent Diagnosed to have urodynamic stress incontinence by urodynamic study and patient chose to have TVT-O Consented for surgical treatment by TVT-O Physically fit for transperineal ultrasound scan

Exclusion criteria

Patient refuse or unable to give written consent Psychiatric patient with cognitive impairment Patient demanding tape excision for voiding dysfunction less than 3 months post-operation

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026