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

Plain Language Summary

Simplified for easier understanding

This study compares two surgical approaches for women with pelvic organ prolapse — where the uterus and vaginal walls slip out of their normal position. One option is the traditional surgery that removes the uterus (vaginal hysterectomy). The other is a newer procedure using a synthetic mesh device called 'Uphold' that supports the vagina without removing the uterus. The study helps women and their surgeons understand which option works better and has fewer complications. You may be eligible if: - You are a woman 18 years of age or older - You have been diagnosed with pelvic organ prolapse at Stage 2 or above with uterine descent causing symptoms - You have been referred for surgical treatment You may NOT be eligible if: - You have unexplained abnormal menstrual or post-menopausal bleeding - You have an abnormal cervical smear result that has not been fully evaluated - You are not up to date with cervical screening - You have evidence of cancer of the uterus or cervix - You have not yet completed your family (you plan to have more children) - You have had previous synthetic mesh used for pelvic organ prolapse - You have a history of chronic pelvic pain - You are unwilling to undergo hysterectomy if randomly assigned to that group Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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