Stress Urinary Incontinence
Conditions
Brief summary
In this proposed study, the investigators aim to evaluate a modified suture urethropexy technique for the treatment of female stress urinary incontinence. Participants will be followed with postoperative visits after 2 weeks, 2 months, and 12 months. Pelvic floor ultrasound imaging will be performed before surgery and after 2 months and 12 months, to evaluate urethral mobility.
Detailed description
This study is designed as a prospective observational study. The hypothesis is that suture urethropexy will improve stress urinary incontinence symptoms in participants with stress urinary incontinence and normal urethral closure pressure at 2 months and 12 months after surgery. Specific Aims: Aim 1: Investigate the efficacy of this mesh-free suture based surgical technique for improving SUI symptoms Aim 2: Investigate the efficacy of this mesh-free suture based surgical technique on key urethral support defects observed with 3D ultrasound
Interventions
PROCEDUREUrethropexy
Suture based (Mesh-free) surgery to stabilize the urethra for the treatment of stress urinary incontinence
Sponsors
Endeavor Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years or older with stress dominant urinary incontinence * Stress urinary incontinence confirmed by testing (e.g. urodynamics) * Able to provide informed consent and attend post-operative visits
Exclusion criteria
* Detrusor overactivity (\> 40cm H2O) * Maximum Urethral Closure Pressure (\< 40 cm H2O) * Post void residual \> 150 mL * Prior surgery for stress urinary incontinence with retained material (e.g. bulking agent, sling)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stress urinary incontinence symptoms | 2 weeks | Severity of stress urinary incontinence symptoms by questionnaire |
| Voiding dysfunction | Within 1 year of surgery | Rate of urinary retention after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distal Urethral Motion | 2 months | Distal urethral swing angle during Valsalva measured via pelvic ultrasound |
| Proximal Urethral Motion | 2 months | Proximal urethral swing angle during Valsalva measured via pelvic ultrasound |
| Post-operative complications | Within 1 year of surgery | Rate of post-operative complications |
Countries
United States
Outcome results
None listed