RecruitingACTRN12616000755437

Comparison of minimally invasive cardinal/uterosacral ligament plication and oral tropsium chloride for urinary urge incontinence in women.


Sponsor

SPMC, Saint-Petersburg University Clinic

Enrollment

192 participants

Start Date

Jun 1, 2016

Study Type

Interventional

Conditions

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”.


Eligibility

Sex: FemalesMin Age: 21 Yearss

Plain Language Summary

Simplified for easier understanding

This trial is comparing two treatments for women with urge urinary incontinence — the sudden strong urge to urinate that leads to leaking. The first treatment is a bladder relaxant medication (trospium chloride taken as a pill). The second is a minimally invasive day-surgery procedure that tightens the ligaments supporting the bladder and uterus. Both approaches are tested in a randomised controlled trial, with follow-up surveys at 6, 12, and 26 weeks. You may be eligible if: - You are a woman aged 21 or older - You have urge incontinence (involuntary leaking with urge to urinate) two or more times per day on an average day - You have a mild to moderate prolapse of the bladder or uterus (POPQ grade 1–3) - Your symptoms improve slightly when a speculum is gently inserted into the back of your vagina (a test done in clinic) You may NOT be eligible if: - You have a severe (grade 3 or 4) uterine prolapse - You have a current urinary tract infection - You have a known neurological condition such as multiple sclerosis - You have had previous vaginal surgery other than a midurethral sling or hysterectomy Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 li

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.


Locations(1)

Saint-Petersburg, Russian Federation

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ACTRN12616000755437


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