None listed
Conditions
Brief summary
Five subjects will be treated with a modification to the traditional way in which a pubo-vaginal sling procedure is performed. Our modification to the technique involves using a new method to attach the sling so that the abdominal incision to secure the tension on the sling is not necessary. The sling anchor then dissolves over time as healing is complete. The sling tissue will be collected from the patient’s lateral thigh as is the usual for this procedure. The study is designed to be a small feasibility study to test that the modification of the procedure for anchoring the sling functions as intended.
Interventions
Performance of an autologous fascia lata pubo-vaginal sling to be tension adjusted using a knotless fixation mechanism without using an abdominal incision.
The intervention will be performed by a subspecialist Urogynaecologist or a Gynaecologist who completed an Advanced Training Module in Urogynaecology.
Mode of care delivery is surgical, provided in operating theatre, with single episode provision of care lasting approximately 1 hour, with clinic follow-up 42-56 days after surgery, including
Performance of an autologous fascia lata pubo-vaginal sling to be tension adjusted using a knotless fixation mechanism without using an abdominal incision. The intervention will be performed by a subspecialist Urogynaecologist or a Gynaecologist who completed an Advanced Training Module in Urogynaecology. Mode of care delivery is surgical, provided in operating theatre, with single episode provision of care lasting approximately 1 hour, with clinic follow-up 42-56 days after surgery, including assessment of voiding function, vaginal examination and completion of the Urinary Distress Inventory-Sort Form (UDI-6). The surgical intervention itself includes using an autologous fascia lata graft which is anchored using a knotless fixation method using polydioxanone sulphate. The autologous graft will remain, and the fixation device will absorb by hydrolysis in approximately 180-238 days. Interventional adherence will be managed by having the assessment being based on intervention received.
Sponsors
University of Otago
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult women with urodynamic stress urinary incontinence who would otherwise be a candidate for a mid-urethral sling procedure.
Exclusion criteria
Urinary incontinence that is not purely urodynamic stress incontinence. Post-void residual volume of urine greater than 100 mL. Body mass index of greater than 35. History of prior significant pelvic or urinary tract reconstructive surgery. Chronic vaginal or pelvic pain. Inability to give informed consent.
Outcome results
None listed