Clinical trial NCT05842005: Mesh-Reduced Sling For Treating Stress Urinary Incontinence, Efficacy and Durability Trial
Official title: Mesh-Reduced Sling For Treating Stress Urinary Incontinence, Efficacy and Durability Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Mesh-reduced sling
Safety
Efficacy
Treatment
Lead sponsor: Endeavor Health
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 15
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is designed as a prospective case series. Our hypothesis is that the 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 purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Symptomatic stress urinary incontinence

Exclusion Criteria:

* Women of childbearing age (0-45 years)
* Previous stress urinary incontinence surgery

Primary outcomes:
measure: PFDI-20 score
timeFrame: 12 months post-op
Secondary outcomes:
measure: Complication measured by distal urethral swing angle
timeFrame: 12 months post-op
measure: Complication measured by proximal urethral swing angle
timeFrame: 12 months post-op
measure: Complication measured by early and remote post-operative complications
timeFrame: 12 months post-op
Other outcomes:
Locations:
city: Skokie
country: United States
facility: NorthShore University Health System
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Henry Chill, MD
role: PRINCIPAL_INVESTIGATOR
References:
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