Mesh-Reduced Sling For Treating Stress Urinary Incontinence, Efficacy and Durability Trial
- Conditions
- Stress Urinary Incontinence
- Interventions
- Device: Mesh-reduced Sling
- Registration Number
- NCT05842005
- Lead Sponsor
- NorthShore University HealthSystem
- Brief Summary
The goal of this pilot study is to report the safety and efficacy of a suture-suspended mesh-reduced sling for treating stress urinary incontinence (SUI) in women.
The main question\[s\] it aims to answer are:
* investigate the efficacy of this mesh-reduced suture-based surgical technique for improving SUI symptoms
* investigate the efficacy of this mesh-reduced suture-based surgical technique on key urethral support defects observed with 3D ultrasound Participants will consent to participate following which they will complete pre-operative assessments according to our routine clinical pathway. The participant will then undergo surgery and will be followed up to 12 months post-operatively via symptom assessment and pelvic exam.
- Detailed Description
Women presenting to our tertiary urogynecology clinic with stress urinary incontinence symptoms based on their answers to PFDI-20 questionnaire and deciding to proceed with surgical treatment of SUI will be invited to participate in this study. Baseline screening will include our standard clinical pathway, which includes symptom review and standard questionnaires, standard vaginal and, urodynamic study and 3D pelvic floor ultrasound. If clinical and ultrasound imaging findings are consistent with SUI in setting of normal urethral closure pressure but lack of urethral support that is state of the art indication for mid-urethral sling procedure, patients will be offered this mesh-reduced mini-sling mesh-reduced sling for treating their condition.
For patients expressing interest, the study procedures and consent will be reviewed during this office visit. Consent will be signed at the following pre-op visit. This study will involve no additional pre-operative tests or questionnaires, beyond our routine clinical pathway for women presenting with SUI with or without pelvic prolapse.
Surgical method Patients participating in this study will undergo standard preoperative and peri-operative care, and anesthetic and pain management care, identical than that which occurs for any pelvic reconstructive surgery within our division. Coexisting pelvic prolapse repairs such as cystocele and rectocele repair, with or without hysterectomy, will be performed per routine.
For treating SUI, the dissection will be completely identical to mid-urethral sling. The difference will be instead of passing the mesh through the tunnels on each side of urethra and exiting through rectus fascia, the investigators will use a ¾ x ⅜ inch polypropylene mesh and place it under the mid urethral. This mesh will be suspended by two suspending permanent sutures on each side to the pubic rami periosteum. At this point sutures will be tied down and the vaginal skin closed with a 2-0 vicryl suture.
Postoperative care This procedure entails no additional or specific post-operative activity limitations or care in comparison to the existing baseline pelvic organ prolapse surgeries. The investigators anticipate that all patients will be discharged from the hospital consistent with normal patterns, either on the same day of surgery or after a brief hospital stay, depending on the meeting of postoperative milestones and discharge criteria.
Follow up Patients will return to the office for postoperative visits at 2 weeks, 2 months, and 12 months after surgery. During the 2-month and 12 month follow-up visits, a vaginal exam and pelvic floor ultrasound will be performed to evaluate healing and urethral motion.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 15
- Symptomatic stress urinary incontinence
- Women of childbearing age (0-45 years)
- Previous stress urinary incontinence surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mesh-reduced Sling Mesh-reduced Sling Mesh-reduced sling will improve stress urinary incontinence (SUI) symptoms in women with SUI and normal urethral closure pressure at 2 months and 12 months after surgery.
- Primary Outcome Measures
Name Time Method PFDI-20 score 12 months post-op Pelvic Floor Disability Index (PFDI-20) score indicating SUI symptom severity. Higher values indicate greater distress or worse outcome. The sub-scales score ranges from 0 to 100. The summary score ranges from 0 to 300.
- Secondary Outcome Measures
Name Time Method Complication measured by proximal urethral swing angle 12 months post-op Investigate the efficacy of this mesh-reduced suture based surgical technique on key urethral support defects observed with 3D ultrasound.
This will be measured by proximal urethral swing angle during Valsalva measured via pelvic ultrasound.Complication measured by early and remote post-operative complications 12 months post-op Investigate the efficacy of this mesh-reduced suture based surgical technique on key urethral support defects observed with 3D ultrasound.
This will be measured by early and remote postoperative complications.Complication measured by distal urethral swing angle 12 months post-op Investigate the efficacy of this mesh-reduced suture based surgical technique on key urethral support defects observed with 3D ultrasound.
This will be measured by distal urethral swing angle during Valsalva measured via pelvic ultrasound.
Trial Locations
- Locations (1)
NorthShore University Health System
🇺🇸Skokie, Illinois, United States