None listed
Conditions
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.
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 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
Sponsors
Southern Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
patients with POP (Pelvic Organ Prolapse) Stage >2 symptomatic uterine descent referred for surgery
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
Outcome results
None listed