Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000755437
Ethics application status
Approved
Date submitted
11/04/2016
Date registered
8/06/2016
Date last updated
10/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of minimally invasive cardinal/uterosacral ligament plication and oral tropsium chloride for urinary urge incontinence in women.
Scientific title
Comparison of minimally invasive cardinal/uterosacral ligament plication and oral tropsium chloride for urinary urge incontinence in women.
Secondary ID [1] 288975 0
Not known
Universal Trial Number (UTN)
Trial acronym
There is no trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Female urinary urge incontinence
 298367 0
Difficulty emptying bladder 298620 0
Chronic pelvic pain 298621 0
Urinary stress incontinence 298622 0
Insensible urine leakage 298623 0
Condition category
Condition code
Renal and Urogenital 298472 298472 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 294462 0
Treatment: Surgery
Intervention code [2] 294646 0
Treatment: Drugs
Comparator / control treatment
An oral anticholinergic drug - oral tablet trospium chloride 15 mg given 3 times a day for 6 months. The monitoring include drug return, laboratory tests,
Control group
Active

Outcomes
Primary outcome [1] 297961 0
The number of patients with urinary urge incontinence, taking zero wet/day as the endpoint for each group as assessed by UDI-6 and CRADI-8
Timepoint [1] 297961 0
at 6 weeks, 12 weeks 26 weeks post intervention
Secondary outcome [1] 322769 0
Blurred vision (assessed by visual acuity test)
Timepoint [1] 322769 0
6 weeks, 12 weeks, 26 weeks post-intervention
Secondary outcome [2] 323415 0
Dry mouth (assessed by subjective complaints)
Timepoint [2] 323415 0
6 weeks, 12 weeks, 26 weeks post-intervention
Secondary outcome [3] 323416 0
Constipation (assessed by subjective complaints)
Timepoint [3] 323416 0
6 weeks, 12 weeks, 26 weeks post-intervention
Secondary outcome [4] 323417 0
Pain (assessed by Numeric Pain Rating Scale (NRS-11))
Timepoint [4] 323417 0
6 weeks, 12 weeks, 26 weeks post-intervention
Secondary outcome [5] 323418 0
Urinary retention (assessed be Ultrasound study)
Timepoint [5] 323418 0
6 weeks, 12 weeks, 26 weeks post-intervention
Secondary outcome [6] 323419 0
Haematoma (assessed by Ultrasound study)
Timepoint [6] 323419 0
6 weeks, 12 weeks, 26 weeks post-intervention
Secondary outcome [7] 323420 0
number of incidents for urge: “good day” “average day" and “bad day”' (assessed by a voiding diary)
Timepoint [7] 323420 0
6 weeks, 12 weeks, 26 weeks post-intervention
Secondary outcome [8] 323833 0
number of incidents for nocturia: “good day” “average day" and “bad day”' (assessed by a voiding diary)
Timepoint [8] 323833 0
6 weeks, 12 weeks, 26 weeks post-intervention

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

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)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) .
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power 95% CI with 1% significance, 192 total (96 each arm) required.
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.

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
Actual
1/06/2016
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] 7802 0
Russian Federation
State/province [1] 7802 0
Saint-Petersburg

Funding & Sponsors
Funding source category [1] 293332 0
Hospital
Name [1] 293332 0
SPMC, Saint-Petersburg University Clinic
Country [1] 293332 0
Russian Federation
Primary sponsor type
Hospital
Name
SPMC, Saint-Petersburg University Clinic
Address
154, embankment of Fontanka river, Saint-Petersburg, Russian Federation, 190103
Country
Russian Federation
Secondary sponsor category [1] 292151 0
None
Name [1] 292151 0
None
Address [1] 292151 0
None
Country [1] 292151 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294801 0
Ethics committee of Saint-Petersburg University Clinic
Ethics committee address [1] 294801 0
154, embankment of Fontanka river, Saint-Petersburg, Russian Federation, 190103
Ethics committee country [1] 294801 0
Russian Federation
Date submitted for ethics approval [1] 294801 0
02/02/2016
Approval date [1] 294801 0
16/03/2016
Ethics approval number [1] 294801 0
02/2016

Summary
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”.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65098 0
Dr Dmitry D. Shkarupa
Address 65098 0
154, embankment of Fontanka river, Saint-Petersburg, 190103
Saint-Petersburg University Clinic
Country 65098 0
Russian Federation
Phone 65098 0
+7 812 6762525
Fax 65098 0
Email 65098 0
[email protected]
Contact person for public queries
Name 65099 0
Dr Dmitry D. Shkarupa
Address 65099 0
154, embankment of Fontanka river, Saint-Petersburg, 190103
Saint-Petersburg University Clinic
Country 65099 0
Russian Federation
Phone 65099 0
+79119204416
Fax 65099 0
Email 65099 0
[email protected]
Contact person for scientific queries
Name 65100 0
Miss Anastasia Zaytseva
Address 65100 0
154, embankment of Fontanka river, Saint-Petersburg, 190103
Saint-Petersburg University Clinic
Country 65100 0
Russian Federation
Phone 65100 0
+79112953055
Fax 65100 0
Email 65100 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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