None listed
Conditions
Brief summary
Vaginal prolapse is a common problem with approximately 1 in 10 women in the developed world requiring prolapse surgery in their lifetime . The problem has a myriad of symptoms ranging from mild discomfort to being very problematic and having a huge impact on quality of life. Surgery is generally seen as a last resort for managing vaginal prolapse, especially if a conservative method has been tried (eg: vaginal pessary device). However, the results of surgery alone are not perfect, and some women will develop recurrent prolapse or not be satisfied with the result. The thought of having a vaginal pessary device inserted at the end of the operation is for the pessary device to take tension away from the native tissue and suture lines and hence improve tissue regeneration, healing without scarring, leading to better surgical results and patient satisfaction. This could revolutionize the way we manage our level 1 and level 2 repairs and may result in better surgical outcomes, lower prolapse recurrence and better quality of life for our women in the long term. This study is to determine if having a vaginal pessary device (shaatz pessary) inserted intraoperatively at the end of vaginal prolapse surgery temporarily for 4 weeks will improve surgical results and patient satisfaction.
Interventions
A vaginal pessary device is a removable device made of silicone. It is normally inserted into the vagina by a gynaecologist to support the prolapsed walls of the vagina and/or uterus. However, the indication in this instance is to take tension away from the native tissue and suture lines post operatively (if randomised to treatment group) which may improve tissue regeneration and healing which could lead to better surgical results and patient satisfaction.
There are various sorts of pessaries a
A vaginal pessary device is a removable device made of silicone. It is normally inserted into the vagina by a gynaecologist to support the prolapsed walls of the vagina and/or uterus. However, the indication in this instance is to take tension away from the native tissue and suture lines post operatively (if randomised to treatment group) which may improve tissue regeneration and healing which could lead to better surgical results and patient satisfaction. There are various sorts of pessaries available. However for this study, we have opted to use a Shaatz type pessary as it is the most applicable for keeping tension off the native tissue while providing extra support to the vagina as it heals from the surgery. Participants if enrolled into the study, would need to fill in a pre-operative questionnaire and post-operative questionnaire. All participants would receive their surgery which would be routine surgery with or without the study. The patients enrolled into the treatment arm would at the end of surgery have the vaginal pessary inserted by the surgeon (which would take an additional 2 minutes) while still under general anaesthesia to minimise discomfort. The total duration of device use is 4 weeks post-surgery and will be removed by Prof Rane at the time for the 4 week post operative review. The associate investigator (urogynaecology fellow) will be doing the pre and post surgery vaginal assessment without being aware of which treatment arm the patient is in so as to have an objective vaginal assessment. Further follow up in the outpatient clinic would be at 3 and 6 months post operative as well.
Sponsors
Mater Hospital - Pimlico
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Women (18 years and over) with symptomatic pelvic organ prolapse requiring an anterior vaginal repair (level 1 or level 2) at our facility - Medically fit for surgery - Able to complete the questionnaire independently with reasonable level of English and English is their first language - Patients that have not been recommended surgery that involves colpocleisis, mesh or other surgical approach (such as laparoscopy or laparotomy)
Exclusion criteria
- Asymptomatic pelvic organ prolapse - Refusal to participate - Women of non-English speaking background
Outcome results
None listed