Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT03676894
Eligibility Criteria:
Inclusion Criteria:
* Female between 18 and 80 years
* SUI or MUI with predominantly stress symptoms for more than 6 months
* Has failed 2 previous non-invasive therapies for three (3) months each (e.g. behavioural modification, electrical stimulation, pelvic muscle exercise, biofeedback, and/or drug therapy)
* Confirmed SUI through cough stress test or urodynamics
* Has at least one incontinence episode per 24 hour period measured over three days
* Valsalva leak-point pressure (VLPP) ≤100 cm H2O
* Has a baseline 24h pad weight test ≥ 10 gm
* Has maximum cystometric capacity ≥250 mL
* No pelvic surgery within last 6 months (including prolapse repair, subjects who have residual or recurrent SUI following colposuspension or a sling procedure may be included in the study if the procedure was conducted at least 6 months prior to screening /baseline visit)
* Willing to give informed consent and complete the follow up schedule
Exclusion Criteria:
* Active urinary tract or vaginal infection or other active infections of urinary tract or bladder (urethritis, cystitis or vaginitis)
* Has had three (3) or more cultured-proven bacterial urinary tract infection (UTI) in the last 12 months
* Clinical diagnosis of urge incontinence or urge predominant mixed incontinence
* Has detrusor overactivity on urodynamics
* postvoiding residual (PVR) \> 100 ml
* Has had previous urethral surgery (i.e. fistula or diverticula)
* Grade 2 or higher Pelvic organ prolapse (POP) or Pelvic organ prolapse grade \> 2 as defined by POP-Q and symptomatic
* Suffers from known polyuria (\>3l/24h)
* Has a BMI ≤35 kg/m2
* Has unevaluated hematuria
* Has a neurogenic bladder
* Evidence of dysplasia in a Pap smear (done in the last 24 months)
* Tumours of the Urinary tract
* Previous radiation or brachytherapy to treat pelvic cancer
* Has uncontrolled diabetes
* Has active herpes genitalis
* Pregnancy, lactating, or not practicing adequate contraception and/or planning to get pregnant in the next 12 months
* Had a vaginal delivery within 6 months prior to the Screening/Baseline Visit
* Is currently participating in any other clinical trial, or has participated in another clinical trial within 3 months prior to the Screening/Baseline Visit
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03676894
Study Brief:
Protocol Section:
NCT03676894