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Trial registered on ANZCTR


Registration number
ACTRN12610000879066
Ethics application status
Approved
Date submitted
14/10/2010
Date registered
19/10/2010
Date last updated
19/10/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective study of single incision transvaginal mesh with apical fixation to treatment of anterior vaginal wall prolapses
Scientific title
Prospective study of single incision transvaginal mesh with single incision polipropilene mesh with transfascial midurethral and apical fixation for treatment of anterior and apical vaginal wall prolapses
Secondary ID [1] 252820 0
nil
Universal Trial Number (UTN)
U1111-1117-1769
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anterior vaginal wall prolapse 258327 0
apical vaginal prolapse 258328 0
stress urinary incontinence 258329 0
Condition category
Condition code
Surgery 258513 258513 0 0
Surgical techniques
Renal and Urogenital 258514 258514 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The procedure is performed with the patient in lithotomy position. After doing a hydrodissection, anterior vaginal wall incision is made from midurethra towards the uterine cervix and the pubocervical fascia is carefully dissected. Blunt dissection is performed towards the ischial spine, and coccigeous muscle, identifying the ischial spines and the sacrospinous ligaments.
Then the retractable insertion guide is primed with the tissue anchoring system and is introduced into the sacrospinous ligament 1.5 cm medial from the ischial spine. The tissue anchoring system is released and the insertion guide is gently retracted. The same maneuvers are repeated on the other side.
For insertion of the implant, first, the retractable insertion guide is connected to the multipoint fixation arm and is introduced towards the internal obturator muscle, one centimeter above the vaginal fornix, guided by surgeon’s index finger. When the centering mark of the implant is at the midurethra at a properly position, the trigger at the handle is retracted to release in place the fixation arm. The multipoint fixation arms design provides strong and stable primary fixation. Cystoscopy is not mandatory.
Then, the polypropylene stitches are attached to the arms of the implant bilaterally. Stitches are placed at the posterior body of the implant and fixed at the remanents of cardinal ligaments or pericervical ring in order to avoid high cystocele reccurence.
Finally, the vaginal incision is closed in the usual manner.
This procedure is performed about 1 hour
Intervention code [1] 257342 0
Treatment: Surgery
Comparator / control treatment
The same group of patients is seen before and after surgery
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259349 0
Pelvic Organ Prolapse Quantification (POPQ) will be assessed through physical examination, in accordance with International Continence Society standardized recommendations.
Timepoint [1] 259349 0
7 days, 1, 3, 6, 12 and 24 months after surgery
Primary outcome [2] 259350 0
Stress Urinary Incontinence will be assessed through clinical history, stres test while doing physical examination and "ICIQ-Urinary Incontinence Form
", an specific questionnaires developed by International Consultation on Incontinence Modular Questionnaire (ICIQ)
Timepoint [2] 259350 0
7 days, 1, 3, 6, 12 and 24 months after surgery
Secondary outcome [1] 265821 0
nil
Timepoint [1] 265821 0
nil

Eligibility
Key inclusion criteria
female
pregnancies defined
no diseases with contraindications for anesthesia
anterior vaginal prolapse with point Ba > +1 (POP-Q classification)
Minimum age
No limit
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
point Bp > -1 or point C > -1 (POP-Q classification),
without tumoral diseases
without urinary infections
without vaginal infections
no previous radioterapy
no pregnancy
no blood dyscrasias or immunosuppression
no psychiatric or neurological diseases

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2951 0
Brazil
State/province [1] 2951 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 257820 0
Hospital
Name [1] 257820 0
Unicamp
Address [1] 257820 0
Rua Vital Brasil, 251 segundo andar, Secretaria de Urologia
Cidade Universitaria Zeferino Vaz;
Campinas
SP
CEP -13083-888
Country [1] 257820 0
Brazil
Primary sponsor type
Commercial sector/Industry
Name
Promedon
Address
R. Manuel da Nóbrega, 354 An13
Paraiso;
Sao Paulo
SP
CEP 04001-001
Country
Brazil
Secondary sponsor category [1] 257022 0
None
Name [1] 257022 0
Address [1] 257022 0
Country [1] 257022 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259850 0
Comite de Etica em Pesquisa - FCM Unicamp
Ethics committee address [1] 259850 0
Ethics committee country [1] 259850 0
Brazil
Date submitted for ethics approval [1] 259850 0
Approval date [1] 259850 0
Ethics approval number [1] 259850 0

Summary
Brief summary
The primary porpose of this study is the assesment of stress urinary incontinence and pelvic organ prolapses healing after new technique of mesh fixation in single incision surgery
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31735 0
Address 31735 0
Country 31735 0
Phone 31735 0
Fax 31735 0
Email 31735 0
Contact person for public queries
Name 14982 0
Tiago Monteiro Barreiro
Address 14982 0
Rua Vital Brasil, 251 segundo andar, Secretaria de Urologia
Cidade Universitaria Zeferino Vaz
Campinas
SP
CEP -13083-888
Country 14982 0
Brazil
Phone 14982 0
55-19-9695511
Fax 14982 0
Email 14982 0
tiagomont@yahoo.com.br
Contact person for scientific queries
Name 5910 0
Tiago Monteiro Barreiro
Address 5910 0
Rua Vital Brasil, 251, segundo andar, Secretaria de Urologia
Cidade Universitária Zeferino Vaz
Campinas
SP
CEP -13083-888
Country 5910 0
Brazil
Phone 5910 0
55- 19- 97695511
Fax 5910 0
Email 5910 0
tiagomont@yahoo.com.br

No information has been provided regarding IPD availability
Summary results
No Results