Precise Transvaginal Tape Placement Trial
| Status: | Completed |
|---|---|
| Conditions: | Overactive Bladder, Urology, Urology |
| Therapuetic Areas: | Gastroenterology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/2/2017 |
| Start Date: | March 2014 |
| End Date: | November 2016 |
This purpose of this study is to study is to see if intra-operative urethral length
measurement with the Foley catheter will improve the placement of a synthetic sling in the
mid-urethra.
measurement with the Foley catheter will improve the placement of a synthetic sling in the
mid-urethra.
This study will assess the effect of intraoperative measurement of the urethral length with
the Foley catheter in optimization of sling placement in the mid female urethra. Of note,
the Foley catheter is well-tolerated, placed routinely during surgery to drain the bladder
and has no complications associated with it. Women who have chosen to undergo trans-vaginal
tape sling (TVT) for stress urinary incontinence will be asked to enroll in this randomized
trial by the study team during their clinic visit. Randomization will be performed by the
FPMRS study nurse coordinator after a woman has given her informed consent and meets the
study criteria. Twenty women will be randomized to undergo measurement of the urethral
length by marking the Foley catheter at the urethral meatus when it is placed at the start
of the surgical case. When the catheter is removed, the length from the end of the Foley
balloon to the marking at the urethra will be measured as urethral length, the mid urethral
point will then be determined by dividing the urethral length be two where the incision of
sling placement will be made and twenty women will have our usual pre-operative assessment
(which does not include intraoperative measurement of the urethral length with the Foley
catheter) for the treatment of symptomatic stress urinary incontinence All women
participating in the study will receive an intra-operative 3-D trans-vaginal ultrasound (BK
Flex Focus ultrasound with the 8838 transvaginal probe). The image will be stored and
reviewed for; urethral length, urethral sphincter complex length and width. All women in the
study will have an ultrasound at the end of their surgical procedure and a follow-up
ultrasound at 2 weeks post operatively to assess for sling migration. Of note, transvaginal
ultrasound is well-tolerated and has no complications associated with it. All ultrasound
measurements will be done by a four qualified surgeons, Dr. Elizabeth Mueller Dr. Ahmed Akl,
Dr. Tanaka Dune, and Dr. Susanne Taege who have been trained on ultrasound measurements. In
addition, women will complete questionnaires assessing their pelvic floor symptoms
pre-operatively and at 2 week following surgery. Instruments used will be the Pelvic Floor
Disorders Inventory (PFDI), Medical Epidemiologic and Social Aging (MESA) and the Patient
Global Impression of Improvement (PGII) [11, 12].
the Foley catheter in optimization of sling placement in the mid female urethra. Of note,
the Foley catheter is well-tolerated, placed routinely during surgery to drain the bladder
and has no complications associated with it. Women who have chosen to undergo trans-vaginal
tape sling (TVT) for stress urinary incontinence will be asked to enroll in this randomized
trial by the study team during their clinic visit. Randomization will be performed by the
FPMRS study nurse coordinator after a woman has given her informed consent and meets the
study criteria. Twenty women will be randomized to undergo measurement of the urethral
length by marking the Foley catheter at the urethral meatus when it is placed at the start
of the surgical case. When the catheter is removed, the length from the end of the Foley
balloon to the marking at the urethra will be measured as urethral length, the mid urethral
point will then be determined by dividing the urethral length be two where the incision of
sling placement will be made and twenty women will have our usual pre-operative assessment
(which does not include intraoperative measurement of the urethral length with the Foley
catheter) for the treatment of symptomatic stress urinary incontinence All women
participating in the study will receive an intra-operative 3-D trans-vaginal ultrasound (BK
Flex Focus ultrasound with the 8838 transvaginal probe). The image will be stored and
reviewed for; urethral length, urethral sphincter complex length and width. All women in the
study will have an ultrasound at the end of their surgical procedure and a follow-up
ultrasound at 2 weeks post operatively to assess for sling migration. Of note, transvaginal
ultrasound is well-tolerated and has no complications associated with it. All ultrasound
measurements will be done by a four qualified surgeons, Dr. Elizabeth Mueller Dr. Ahmed Akl,
Dr. Tanaka Dune, and Dr. Susanne Taege who have been trained on ultrasound measurements. In
addition, women will complete questionnaires assessing their pelvic floor symptoms
pre-operatively and at 2 week following surgery. Instruments used will be the Pelvic Floor
Disorders Inventory (PFDI), Medical Epidemiologic and Social Aging (MESA) and the Patient
Global Impression of Improvement (PGII) [11, 12].
Inclusion Criteria:
- Candidates for TVT
- >=18 years of age to participate
Exclusion Criteria:
- Inability to give informed consent
- Previous SUI(stress urinary incontinence) treatment including TVT, Burch or urethral
bulking agents
- Previous bladder, urethral malignancies or vaginal/pelvic radiation treatment.
- Pregnant women cannot participate
We found this trial at
1
site
Click here to add this to my saved trials
