None listed
Conditions
Brief summary
BACKGROUND TO THE RCT two main paradigms as regards causation and treatment of “Overactive Bladder Syndrome”(OAB-frequency, urgency, nocturia), the ICS (International Society) paradigm and the Integral Theory (IT) paradigm. The Integral Theory (IT) paradigm considers OAB symptoms as originating outside the bladder, a result of laxity in the vagina or its supporting ligaments. The Theory predicts that reinforcing the cardinal/uterosacral ligament complex will reverse this cascade of events, thereby improving FNU symptoms. The surgical operations are minimal, usually day-care.The ICS (International Society) paradigm considers that the cause of OAB arises in the bladder, so it is the bladder which must be treated. The principal management of OAB therefore is non-surgical, some type of anticholinergic. OBJECTIVES OF THE RCT STUDY is to challenge both paradigms. Primary aim A multicentre RCT of anticholinergic drugs (Solfenacin) against surgical treatment of OAB, reinforcing the cardinal and uterosacral ligaments in patients presenting principally with > 2 per day of urge incontinence symptoms. Secondary aim To validate (or not) the IT paradigm’s predictions that strengthening the cardinal/USL complex will also improve other bothersome pelvic floor symptoms: nocturia, chronic pelvic pain “obstructive” micturition and defecation and non-sphincteric fecal incontinence and whether there is any effect of anticholinergics on these symptoms. Trial Design Parallel study, native tissue ligament plication vs anticholinergics for patients wetting two or more times /day with urge incontinence symptoms. End points/outcomes of the study Review each arm at 6 weeks, 12 weeks and 26 weeks using UDI-6, CRADI-8 plus urge and nocturia as per Table 1, ‘good day’, ‘average day’, ‘bad day’. For power of 95% CI with 1% significance, 192 patients total (96 each arm) are required and will be recruited. Symptom improvement for each arm endpoint /baseline will be statistically assessed. Comparison of the endpoint results from one arm against the other will be statistically assessed. Two cohorts, randomized for either medical treatment (Solfenacin) or surgical treatment, ‘native tissue’ reconstruction of cardinal and uterosacral ligaments. At 6 months, all patients are re-assessed as regards OAB and other symptoms with the modified USI-6 questionnaire. Cessation of treatment will be considered a failure. Informed consent for both arms will be completed before treatment and relevant Patient Information printed materials will be provided. Inclusion criteria, Urge incontinence with wetting twice or more per average day, POPQ grade 1-2 cystocele or apical POP,Improvement of urge symptoms by gentle insertion of speculum into the posterior vaginal fornix, fig 1 Exclusion Criteria, Patients with 3rd or 4th degree uterine POP, Urinary tract infections, Known neurological conditions, for example multiple sclerosis, Patients with previous vaginal surgery
Interventions
A randomized trial comparing two treatments for urge incontinence
Arm 1: an anticholinergic drug (Solifenacin)given 5 mg once daily for 6 months.
Arm 2: surgical plication of the cardinal/uterosacral ligaments plication- this is a minimally invasive a day care operation.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 limitat
A randomized trial comparing two treatments for urge incontinence Arm 1: an anticholinergic drug (Solifenacin)given 5 mg once daily for 6 months. Arm 2: surgical plication of the cardinal/uterosacral ligaments plication- this is a minimally invasive a day care operation.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 procedure requires approximately 15-30 minutes to complete and is performed by a gynecologist with minimum 5 years of experience treating women with urge incontinence, 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
Mugla Sitki Kocman University
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Urge incontinence with wetting twice or more per on an average day POPQ grade 1-3 cystocele or apical POP Improvement of urge symptoms by gentle insertion of speculum into the posterior vaginal fornix
Exclusion criteria
Patients with 3rd or 4th degree uterine POP Urinary tract infections Known neurological conditions, for example multiple sclerosis Patients with previous vaginal surgery (other than midurethral sling or hysterectomy).
Outcome results
None listed