An observational study in Stress Urinary Incontinence, sponsored by Endeavor Health. Status unknown at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-13.
Sponsored by Endeavor Health · Observational
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.
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
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's planned enrollment of 15 is below the median of 120 across 305 observational studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Endeavor Health is the lead sponsor of 110 studies on the registry; 34 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 9 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants with female pelvic anatomy, 18 years or older, with stress dominant urinary incontinence interested and eligible for surgical treatment
Exclusion Criteria:
Suture based (Mesh-free) surgery to stabilize the urethra for the treatment of stress urinary incontinence
Stress urinary incontinence symptoms
Severity of stress urinary incontinence symptoms by questionnaire
Time frame: 2 weeks
Stress urinary incontinence symptoms
Severity of stress urinary incontinence symptoms by questionnaire
Time frame: 3 months
Stress urinary incontinence symptoms
Severity of stress urinary incontinence symptoms by questionnaire
Time frame: 12 months
Voiding dysfunction
Rate of urinary retention after surgery
Time frame: Within 1 year of surgery
Distal Urethral Motion
Distal urethral swing angle during Valsalva measured via pelvic ultrasound
Time frame: 2 months
Distal Urethral Motion
Distal urethral swing angle during Valsalva measured via pelvic ultrasound
Time frame: 12 months
Proximal Urethral Motion
Proximal urethral swing angle during Valsalva measured via pelvic ultrasound
Time frame: 2 months
Proximal Urethral Motion
Proximal urethral swing angle during Valsalva measured via pelvic ultrasound
Time frame: 12 months
Post-operative complications
Rate of post-operative complications
Time frame: Within 1 year of surgery
Plan to share: No
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Endeavor Health