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Trial registered on ANZCTR


Registration number
ACTRN12611000633987
Ethics application status
Approved
Date submitted
9/06/2011
Date registered
22/06/2011
Date last updated
7/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Hysterectomy or Uphold Uterine Conservation in women with apical prolapse – a Comparative Trial (HUUT)
Scientific title
in patients with uterine prolapse, is uterine conservation using Uphold mesh kit as good as or better than vaginal hysterectomy for prolapse recurrence
Secondary ID [1] 262352 0
Nil
Universal Trial Number (UTN)
Trial acronym
HUUT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
symptomatic uterine prolapse 268054 0
Condition category
Condition code
Renal and Urogenital 268196 268196 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 268262 268262 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
uterine conservation using Uphold vaginal mesh kit - this involves conserving (or keeping) the uterus and (re)suspending it using a mesh kit. The mesh kit consists of polypropylene mesh with arm that provides an anchor within the sacrospinous ligament. This permanent mesh provides support for the uterus and also the anterior part of the vagina. approximate duration 1.25h
Intervention code [1] 266743 0
Treatment: Surgery
Intervention code [2] 266744 0
Treatment: Devices
Comparator / control treatment
Vaginal hysterectomy: This is a "standard" operation involving removal of uterus, through the vagina. The ligamentous support are used to resuspend the vaginal walls. approximate duration - 1h
Control group
Active

Outcomes
Primary outcome [1] 266935 0
Incidence of apical POP (pelvic organ prolapse) stage >2 (Point C below -1cm)
Timepoint [1] 266935 0
12 months after surgery
36 months after surgery
Secondary outcome [1] 276655 0
Incidence of overall POP stage >2
Timepoint [1] 276655 0
12 months after surgery
36 months after surgery
Secondary outcome [2] 276765 0
Change in Subjective symptoms score (PFDI 20)
Timepoint [2] 276765 0
12 months after surgery
36 months after surgery
Secondary outcome [3] 276766 0
Change in impact / quality of life (PFIQ 7)
Timepoint [3] 276766 0
12 months after surgery
36 months after surgery
Secondary outcome [4] 276767 0
Change in sexual functioning (PISQ 12)
Timepoint [4] 276767 0
12 months after surgery
36 months after surgery
Secondary outcome [5] 276768 0
Change in overall / global impression of improvement (PGI I)
Timepoint [5] 276768 0
12 months after surgery
36 months after surgery

Eligibility
Key inclusion criteria
patients with POP (Pelvic Organ Prolapse) Stage >2 symptomatic uterine descent referred for surgery
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unevaluated dysfunctional (or post menopausal) menstrual bleeding 2. Unevaluated cervical smears abnormality 3. Non compliant to cervical screening 4. Evidence of endometrial or cervical (including high grade precancerous lesions) malignancy 5. Family incomplete 6. Previous synthetic mesh used for POP 7. Previous uterine suspension 8. History of chronic pelvic pain, including interstitial cystitis 9. Unwilling to undergo 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)
central randomisation by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random table
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267230 0
Commercial sector/Industry
Name [1] 267230 0
Boston Scientific
Address [1] 267230 0
Level 5 247 Coward Street Mascot NSW 2020
Country [1] 267230 0
Australia
Primary sponsor type
Hospital
Name
Southern Health
Address
823-865 Centre Rd East Bentleigh VIC 3165
Country
Australia
Secondary sponsor category [1] 266294 0
Hospital
Name [1] 266294 0
Mercy Hospital for Women
Address [1] 266294 0
169 Studley Road Heidleberg VIC 3084
Country [1] 266294 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269221 0
southern Health HREC
Ethics committee address [1] 269221 0
Research Directorate
Southern Health
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Australia
Ethics committee country [1] 269221 0
Australia
Date submitted for ethics approval [1] 269221 0
Approval date [1] 269221 0
17/01/2012
Ethics approval number [1] 269221 0
11145B

Summary
Brief summary
Female pelvic organ prolapse, which is a protrusion of vaginal walls beyond the hymen, is both common and have a high burden of suffering. The traditional operation to treat utero-vaginal prolapse has been vaginal hysterectomy and concomitant vaginal repair, which is not without operative morbidity. The uterus itself may not be the cause for prolapse. There is also increasing recognition that women may wish to avoid hysterectomy at the time of their prolapse operation. Modern advances involve development of minimally invasive procedures which saw the introduction of vaginal mesh kits which provides better success rates when compared to the traditional operation, although not without its own sets of operative morbidity. These procedures involve inserting synthetic material anchored to the sacrospinous ligament to provide reinforcement and support to the vagina following its repair. Uphold is a new mesh kit which utilises a standard synthetic mesh using a surgical approach (anterior sacrospinous) that has been well established since 2001. The purpose of this project is to evaluate the success of Uphold vaginal mesh support or vaginal hysterectomy in the treatment of women with utero-vaginal prolapse.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32725 0
Address 32725 0
Country 32725 0
Phone 32725 0
Fax 32725 0
Email 32725 0
Contact person for public queries
Name 15972 0
Alison Leitch
Address 15972 0
c/o Urodynamic Clinic
823 - 865 Centre Road
East Bentleigh VIC 3165
Country 15972 0
Australia
Phone 15972 0
+61399288588
Fax 15972 0
+61399288338
Email 15972 0
alison.leitch@southernhealth.org.au
Contact person for scientific queries
Name 6900 0
Joseph Lee
Address 6900 0
c/o Urodynamic Clinic
823 - 865 Centre Road
East Bentleigh VIC 3165
Country 6900 0
Australia
Phone 6900 0
+61399288588
Fax 6900 0
+61399288338
Email 6900 0
joseph.lee@southernhealth.org.au

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