None listed
Conditions
Brief summary
Female anterior pelvic organ prolapse (POP) is common. In POP, the vaginal tissues become weak, causing descent of vaginal walls. In moderate to severe anterior POP, conservative treatments may be unsuccessful. In these cases surgical treatments can include: *Surgical repair with a patient’s own tissue (anterior colporrhaphy) *Surgical repair with reinforcement using a tissue graft to provide additional support. The aim of this study is to compare two established surgical techniques for anterior POP to determine which has the best result. The primary outcome will be measured using the following criteria. All three must be met qualify as success: 1) objective measures (anatomical), 2) subjective measures (validated quality of life questionnaire), 3) participant not having repeat procedure for anterior POP recurrence. The primary outcome will be assessed at one year after surgery. This is a multicentre blinded prospective randomised trial. Participants will be randomised to: 1. Anterior colporrhaphy 2. Xenform anterior vaginal repair Both procedures are routinely performed by urogynaecologists in the private and public sectors. Xenform Matrix (Boston Scientific, Marlborough, MA, USA) is used in Australia and by the urogynaecologists in Perth in the private and public sectors for surgical repair of POP. Xenform has been approved since 2010 for POP repair by the Australian Therapeutic Goods Administration. For the participants at Hollywood Private Hospital, they will be recruited from the surgeon’s private rooms. Participants will be eligible if they have symptomatic anterior POP to the level of the hymen and desire surgical treatment. At recruitment, participants will have a pelvic examination to assess pelvic organ prolapse quantification (POP-Q as per International Continence Society). A validated quality of life questionnaire (QoL) (Pelvic Floor Distress Inventory Short Form 20) will also be administered. POP-Q and PFDI-20 will be repeated one year after the operation.
Interventions
Xenform anterior repair
The procedure for standardised Xenform anterior repair is as follows. Vaginal sub-epithelial layer infiltrated with local anaesthetic/saline solution to aid hydrodissection in the sub-epithelial fascial layer. After midline vertical skin incision a full skin thickness dissection of the anterior vaginal wall made from the level of bladder neck to the vaginal apex and bilaterally to each vaginal sulcus. The endopelvic fascia is reinforced by standard midline plication with
Xenform anterior repair The procedure for standardised Xenform anterior repair is as follows. Vaginal sub-epithelial layer infiltrated with local anaesthetic/saline solution to aid hydrodissection in the sub-epithelial fascial layer. After midline vertical skin incision a full skin thickness dissection of the anterior vaginal wall made from the level of bladder neck to the vaginal apex and bilaterally to each vaginal sulcus. The endopelvic fascia is reinforced by standard midline plication with 2-0 polydioxanone suture. A 10" by 7" Xenform graft is shaped to make an anterior based sacrospinous graft. Graft arms anchored to sacrospinous ligament with a Capio suturing device using 0 Monodec suture. The graft is tacked to vaginal sulci, apex and bladder neck plus 2 central sutures over the midline fascial plication.using 2.0 PDS. Vagina is closed with a single locking 2-0 polyglactin suture. Cystourethroscopy after intravenous Indigo carmine is performed. Performed by Urogynaecologist or urogynaecology fellow Duration 45-60 minutes
Sponsors
Dr Todd Ladanchuk
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Symptomatic anterior POP at or beyond hymen (point Ba greater than or equal to 0) AND 2. Desire for surgery
Exclusion criteria
1. Previous POP surgery with implant in target compartment OR 2. Age less than 40 years OR 3. Unfinished family OR 4. Connective tissue disease OR 5. Uncontrolled diabetes OR 6. Prior pelvic radiation OR 7. Vaginal ulceration OR 8. Apical vaginal compartment warranting targeted vault colpopexy
Outcome results
None listed