None listed
Conditions
Brief summary
Ten participants 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, and that no leg or abdominal incision is required to harvest the graft. This procedure does not use permanent mesh. The sling anchor and graft then absorbs over time as healing is complete. 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 when using a bioengineered animal tissue graft.
Interventions
Performance of a pubo-vaginal sling to be tension adjusted using a knotless fixation mechanism without using an abdominal incision. The sling graft will be a bioengineered animal tissue graft with regulatory approval for surgical implantation (Myriad Matrix, Aroa Biosurgery, Auckland, NZ).
The intervention will be performed by a subspecialist Urogynaecologist or a Gynaecologist who completed an Advanced Training Module in Urogynaecology who has surgical credentials to perform pubo-vaginal sling
Performance of a pubo-vaginal sling to be tension adjusted using a knotless fixation mechanism without using an abdominal incision. The sling graft will be a bioengineered animal tissue graft with regulatory approval for surgical implantation (Myriad Matrix, Aroa Biosurgery, Auckland, NZ). The intervention will be performed by a subspecialist Urogynaecologist or a Gynaecologist who completed an Advanced Training Module in Urogynaecology who has surgical credentials to perform pubo-vaginal sling procedures. Mode of care delivery is surgical, provided in operating theatre, with single episode provision of care lasting approximately 30 minutes, 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 a tissue graft as described above which is anchored using a knotless fixation method using polydioxanone sulphate barbed suture. The biograft will be fully integrated within 120 days, 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
Health New Zealand (Investigator initiated study)
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 people with urodynamic stress urinary incontinence who would otherwise be a candidate for an incontinence 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. Lack of a patent vagina. Chronic vaginal or pelvic pain. Inability to give informed consent. Current pregnancy.
Outcome results
None listed