ANZCTR - Registration

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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]

not known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Female urinary urge incontinence

Urinary stress incontinence

Solid fecal incontinence

Liquid fecal incontinence

Wind incontinence

Rectal prolapse

Condition category

Condition code

Surgery

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]

Treatment: Surgery

Intervention code [2]

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]

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]

6 months post randomisation

Secondary outcome [1]

Change in UDI-6 score from baseline.

Timepoint [1]

6 weeks, 12 weeks and 26 weeks post randomisation

Secondary outcome [2]

Change in CRADI-8 score from baseline

Timepoint [2]

6 weeks, 12 weeks and 26 weeks post randomisation

Secondary outcome [3]

Side effects of anticholinergic therapy such as blurred vision, dry mouth, constipation will be assessed by reviewing medical records.

Timepoint [3]

6 weeks, 12 weeks and 26 weeks post randomisation.

Secondary outcome [4]

Complications from the surgery such as pain, urinary retention, infection and haematoma will be assesed by reviewing medical records.

Timepoint [4]

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?

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]

Turkey

State/province [1]

Mugla

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Ahmet Akin Sivaslioglu

Address [1]

Mugla Sitki Kocman University
School of Medicine
Department of Obstetrics and Gynecology
48000 Mugla/Turkey

Country [1]

Turkey

Primary sponsor type

University

Name

Mugla Sitki Kocman University

Address

Mugla Sitki Kocman University
48000 Mugla/Turkey

Country

Turkey

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mugla Sitki Kocman University School of Medicine, Ethics Committee for Clinical Studies

Ethics committee address [1]

Mugla Sitki Kocman University School of Medicine
48000 Mentese/Mugla

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

04/11/2016

Approval date [1]

19/12/2016

Ethics approval number [1]

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

Prof Ahmet Akin Sivaslioglu

Address

Mugla Sitki Kocman University School of Medicine
Department of Obstetrics and Gynecology
48000 Mentese/Mugla

Country

Turkey

Phone

+90 532 277 0618

Fax

akinsivaslioglu@mu.edu.tr

Contact person for public queries

Name

Burcu Kasap

Address

Mugla Sitki Kocman University School of Medicine
Department of Obstetrics and Gynecology
48000 Mentese/Mugla

Country

Turkey

Phone

+905052711056

Fax

burcuharmandar@mu.edu.tr

Contact person for scientific queries

Name

Burcu Kasap

Address

Mugla Sitki Kocman University School of Medicine
Department of Obstetrics and Gynecology
48000 Mentese/Mugla

Country

Turkey

Phone

+905052711056

Fax

burcuharmandar@mu.edu.tr

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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Documents added automatically

No additional documents have been identified.

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