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Trial registered on ANZCTR


Registration number
ACTRN12617000284369
Ethics application status
Approved
Date submitted
29/12/2016
Date registered
23/02/2017
Date last updated
2/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of oral Solifenacin versus minimally invasive surgery in treatment of urge incontinence.
Scientific title
Which one is the best for curing urge incontinence: oral Solifenacin or minimally invasive surgery ?
Secondary ID [1] 290816 0
not known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Female urinary urge incontinence
 301469 0
Urinary stress incontinence
 301470 0
Solid fecal incontinence 301476 0
Liquid fecal incontinence 301477 0
Wind incontinence 301478 0
Rectal prolapse 301481 0
Condition category
Condition code
Surgery 301412 301412 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 296736 0
Treatment: Surgery
Intervention code [2] 296919 0
Treatment: Drugs
Comparator / control treatment
Patients in the control group will be given Solifenacin 5 mg once, given orally, per Day
Control group
Active

Outcomes
Primary outcome [1] 300611 0
The number of patients cured of their urinary urge incontinence, taking zero wet/day as the endpoint for each group. This outcome is assessed by UDI-6. Urinary urge incontinence cure is defined as symptomatic improvement in urge incontinence.
Timepoint [1] 300611 0
6 months post randomisation
Secondary outcome [1] 330410 0
Change in UDI-6 score from baseline.
Timepoint [1] 330410 0
6 weeks, 12 weeks and 26 weeks post randomisation
Secondary outcome [2] 330912 0
Change in CRADI-8 score from baseline
Timepoint [2] 330912 0
6 weeks, 12 weeks and 26 weeks post randomisation
Secondary outcome [3] 330913 0
Side effects of anticholinergic therapy such as blurred vision, dry mouth, constipation will be assessed by reviewing medical records.

Timepoint [3] 330913 0
6 weeks, 12 weeks and 26 weeks post randomisation.
Secondary outcome [4] 331319 0
Complications from the surgery such as pain, urinary retention, infection and haematoma will be assesed by reviewing medical records.
Timepoint [4] 331319 0
6 weeks, 12 weeks and 26 weeks

Eligibility
Key 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
Minimum age
21 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Power 95% CI with 1% significance, 192 total (96 each arm) required.
Statistical analysis
Paired binary response data (per-patient presence/absence of a specific sign/symptom before vs. after surgery/anticholinergic treatment) in the total study cohort were analyzed with a McNemar’s test, with a null hypothesis of no treatment effect.
The GraphPad Quickcalcs platform was used for this analysis (http://graphpad.com/quickcalcs/mcNemar1/). The sample size (https://www.statstodo.com/SSizMcNemar_Pgm.php) was deemed sufficient to assume a Chi-squared distribution. The Chi-square was calculated with one degree of freedom.
Post-hoc estimation of the study power was performed, assuming an alpha error equal to 0.01 (https://www.statstodo.com/SSizMcNemar_Pgm.php). In all cases the estimated power for this comparison exceeded 0.95 (table 1).

To evaluate differences between the proportions of patients showing or not a specific sign/symptom when treated with different techniques (CL/USL reinforcement vs. anticholinergics), the Z-ratio and the 95% confidence interval for the difference between independent proportions were calculated.

The Vassar Stats platform was used for this analysis (www.vassarstats.net).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2017
Actual
1/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
192
Accrual to date
Final
Recruitment outside Australia
Country [1] 8531 0
Turkey
State/province [1] 8531 0
Mugla

Funding & Sponsors
Funding source category [1] 295242 0
Self funded/Unfunded
Name [1] 295242 0
Ahmet Akin Sivaslioglu
Country [1] 295242 0
Turkey
Primary sponsor type
University
Name
Mugla Sitki Kocman University
Address
Mugla Sitki Kocman University
48000 Mugla/Turkey
Country
Turkey
Secondary sponsor category [1] 294069 0
None
Name [1] 294069 0
Address [1] 294069 0
Country [1] 294069 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296581 0
Mugla Sitki Kocman University School of Medicine, Ethics Committee for Clinical Studies
Ethics committee address [1] 296581 0
Mugla Sitki Kocman University School of Medicine
48000 Mentese/Mugla
Ethics committee country [1] 296581 0
Turkey
Date submitted for ethics approval [1] 296581 0
04/11/2016
Approval date [1] 296581 0
19/12/2016
Ethics approval number [1] 296581 0
16/1

Summary
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71362 0
Prof Ahmet Akin Sivaslioglu
Address 71362 0
Mugla Sitki Kocman University School of Medicine
Department of Obstetrics and Gynecology
48000 Mentese/Mugla
Country 71362 0
Turkey
Phone 71362 0
+90 532 277 0618
Fax 71362 0
Email 71362 0
[email protected]
Contact person for public queries
Name 71363 0
Burcu Kasap
Address 71363 0
Mugla Sitki Kocman University School of Medicine
Department of Obstetrics and Gynecology
48000 Mentese/Mugla
Country 71363 0
Turkey
Phone 71363 0
+905052711056
Fax 71363 0
Email 71363 0
[email protected]
Contact person for scientific queries
Name 71364 0
Burcu Kasap
Address 71364 0
Mugla Sitki Kocman University School of Medicine
Department of Obstetrics and Gynecology
48000 Mentese/Mugla
Country 71364 0
Turkey
Phone 71364 0
+905052711056
Fax 71364 0
Email 71364 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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