None listed
Conditions
Brief summary
It is known that anticholinergic drugs are slightly more effective than placebo and the majority of treatments are discontinued because of side effects. It is also known since 1993, that symptoms of urgency, nocturia, pelvic pain and other symptoms are potentially curable in up to 85% of cases with a minimally invasive day-care operation which tightens the cardinal and uterosacral ligaments. The minimally invasive nature of the operation makes it ethically possible for a trial to be performed. A multicentre trial (RCT) testing these two methods in patients presenting with urge incontinence (i.e., uncontrolled wetting with urge two or more times per day). The fate of these (and other) symptoms will be monitored at 6 weeks, 12 weeks and 26 weeks with scientifically valid questionnaires UDI-6, CRADI-8 and so as to allow for variability in the results, number of incidents for urge and nocturia: “good day” “average day and “bad day”.
Interventions
A randomized trial comparing two treatments for urge incontinence
Arm 1: an anticholinergic drug trospium chloride given daily for 6 months.
Arm 2: surgical plication of the cardinal/uterosacral ligaments plication- this is a minimally invasive a day care operation. The operation takes about 25-30 minutes and performed via the vagina. It involves two small incisions in the vagina. The ligaments are located and repositioned with 2 sutures only. The vagina is closed and the patient is sent home o
A randomized trial comparing two treatments for urge incontinence Arm 1: an anticholinergic drug trospium chloride given daily for 6 months. Arm 2: surgical plication of the cardinal/uterosacral ligaments plication- this is a minimally invasive a day care operation. The operation takes about 25-30 minutes and performed via the vagina. It involves two small incisions in the vagina. The ligaments are located and repositioned with 2 sutures only. The vagina is closed and the patient is sent home on the same day with very minor limitations as to what they can or cannot do. The urologist delivers the intervention with minimum 5 years’ experience; Monitoring of compliance: by drug returns of treatment success: by the UDI-6 and where relevant CRADI-8 questionnaires at 6 weeks, 12 weeks 26 weeks also, the number of patients who completed the treatment.
Sponsors
SPMC, Saint-Petersburg University Clinic
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Urge incontinence with wetting twice or more per on an average day 2. POPQ grade 1-3 cystocele or apical POP 3. Improvement of urge symptoms by gentle insertion of speculum into the posterior vaginal fornix,
Exclusion criteria
1. Patients with 3rd or 4th degree uterine POP 2. Urinary tract infections 3. Known neurological conditions, for example multiple sclerosis 4. Patients with previous vaginal surgery (other than midurethral sling or hysterectomy).
Outcome results
None listed