Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Carelon Research
Age
21–any
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible if
Female
Stress urinary incontinence (SUI) as evidenced by all of the following:
Self-reported stress-type urinary incontinence symptoms, of duration ≥ 3 months
Medical, Epidemiological and Social Aspects of Aging (MESA) stress symptom score (percent of total possible stress score) greater than MESA urge symptom score (percent of total possible urge score)
Observation of leakage by provocative stress test at a bladder volume ≤ 300ml
Bladder capacity ≥ 200ml by stress test
Post-void residual (PVR) ≤ 100cc with pelvic organ prolapse (POP) Stage I or lower. If POP is Stage II-IV, PVR \>100cc but ≤ 500cc is allowed
Eligible for both retropubic and transobturator procedures
No medical contraindications, e.g., current urinary tract infection (UTI), history of pelvic irradiation, history of lower urinary tract cancer
American Society of Anesthesiologists (ASA) class I, II, or III
No current intermittent catheterization
Available for 24-months of follow-up and able to complete study assessments, per clinician judgment
Signed consent form
You may not be if
Age \<21 years
Non-ambulatory (ambulatory with assistive devices does not exclude the patient)
Pregnancy by self-report or positive pregnancy test, or self-reported intention to ever become pregnant
Current chemotherapy or current or history of pelvic radiation therapy
Systemic disease known to affect bladder function (i.e., Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury or trauma)
Urethral diverticulum, current or previous (i.e. repaired)
Prior augmentation cystoplasty or artificial sphincter
Implanted nerve stimulators for urinary symptoms
History of synthetic sling for stress urinary incontinence
\<12 months post-partum
Laparoscopic or open pelvic surgery \<3 months\*
Current evaluation or treatment for chronic pelvic pain (painful bladder syndrome)
Participation in another treatment intervention trial that might influence the results of this trial
Need for concomitant surgery requiring an abdominal incision, use of graft material in the anterior compartment, or any use of synthetic graft material
Enrollment in other urinary incontinence trials including SISTEr/E-SISTEr or BE-DRI/E-BE-DRI
