RecruitingACTRN12611000633987

Hysterectomy or Uphold Uterine Conservation in women with apical prolapse – a Comparative Trial (HUUT)

in patients with uterine prolapse, is uterine conservation using Uphold mesh kit as good as or better than vaginal hysterectomy for prolapse recurrence


Sponsor

Southern Health

Enrollment

114 participants

Start Date

Jul 1, 2011

Study Type

Interventional

Conditions

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.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Inclusion Criteria1

  • patients with POP (Pelvic Organ Prolapse) Stage >2 symptomatic uterine descent referred for surgery

Exclusion Criteria1

  • 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

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Interventions

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

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


Locations(1)

Australia

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ACTRN12611000633987