Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06641804
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Vaginal Prolapse Pessary Material Trial PVC vs Silicon
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Materials of Vaginal Ring Pessary for Pelvic Organ Prolapse on the Effects of Complications and Patients Satisfaction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to determine the effect of vaginal ring pessary material on pessary complications and patients satisfaction
Participants who are using PVC polyvinyl chloride pessary will be randomized to
1 PVC vaginal ring pessary
2 Silicon vaginal ring pessary
Their pessary-related complications patients satisfaction pain during pessary exchange and prolapse related symptoms with reference to PFDI-20 score will be assessed in a period of six months
Participants who are using PVC polyvinyl chloride pessary will be randomized to
1 PVC vaginal ring pessary
2 Silicon vaginal ring pessary
Their pessary-related complications patients satisfaction pain during pessary exchange and prolapse related symptoms with reference to PFDI-20 score will be assessed in a period of six months
Detailed Description:
Pelvic organ prolapse POP is a common gynaecological condition which attains prevalence of 15 women It causes negative impact on physical emotional and psychosexual aspects thus significantly impairs patients activities of daily living and quality of life Treatment modalities include conservative pessary and surgical management Vaginal pessary is inexpensive non-invasive and an attractive treatment option for women who possess high anaesthetic and surgical risks Pessary-related complications include vaginal ulcer vaginitis which would require temporary discontinuation of pessary use in order to prevent serious complications such as incarceration and fistula formation If complications can be minimised it is more likely that patients satisfaction can further improve
Vaginal pessaries are primarily made of polyvinyl chloride PVC or silicone PVC has been the material of choice for local practice based on its long history in clinical use and cheaper cost A new PVC pessary is inserted at each consultation if vaginal condition is satisfactory In view of the increasing number of POP patients who opt for long term pessary use silicone has emerged as alternative material of choice in recent years Despite being more expensive silicone pessaries can be washed and re-inserted for 20 washes10 years if remained intact and not visibly damaged As silicone pessary is more pliable it can facilitate the process of pessary insertion and removal by squeezing of the pessary to pass through narrow introitus On the other hand it may be more easily compressed by abdominal pressure and dislodged when straining The UK clinical guideline for best practice in the use of vaginal pessaries for POP in 2021 suggested there is no clear preference of offering one type of pessary over another further supported by the latest publication of a multi-centre pessary study in the UK in 2023
The primary objective is to determine the effect of vaginal ring pessary material on pessary complications and patients satisfaction The secondary objectives are to explore the effect of pessary material on procedural pain during pessary exchange as well as prolapse-related symptoms It is hypothesised that silicone pessaries compared to PVC pessaries can reduce the rate of pessary-related complications from 30 to 10 and also result in higher patients satisfaction
This is a single-blinded randomised placebo-controlled trial conducted in the pessary clinic in Princess Margaret Hospital
Participants are assessed for eligibility when they present to pessary clinic for routine pessary care
Participants are recruited and assigned randomly in 11 ratio to receive either
Treatment arm replacement of a new silicone pessary
Control arm replacement of a new PVC pessary Participants are randomly assigned to one of the two groups in 11 ratio Randomization is carried out by an independent statistician according to computer-generated random numbers in random blocks of two four and six allocated by sequentially numbered sealed opaque envelopes When participants are prepared for pessary care inside the examination room the new pessary will be prepared by research assistant outside the examination room according to the allocation result The attending staff will conduct routine pessary care including pessary removal vaginal examination and pessary replacement Participants are not informed of the material of the new pessary Standard patient information leaflet regarding pessary care with hotlines is provided A 6-month follow up appointment will be arranged
Participants will subsequently attend follow up 6 months later A questionnaire will be given by the research assistant before the consultation to enquire for any pessary-related symptoms and their satisfaction on the current pessary During the consultation the attending staff will remove the study pessary and assess the vaginal condition The study is concluded by a short questionnaire and routine pessary care follows subsequently
Data Collection Patient age parity menopausal status stage of prolapse on presentation previous duration of pessary use history of pessary complications are obtained from hospital record as demographic data
Symptoms of pessary-related complications and patients satisfaction are collected by self-administered questionnaires Signs of pessary-related complications are assessed and documented by the attending staff
Statistical Analysis Baseline characteristics and outcomes of PVC pessary group and silicone pessary group are compared using independent t-test Mann-Whitney U test Pearsons chi-square test or Fishers exact test where appropriate
Odds ratio for complications with 95 confidence interval was calculated The within-group changes of patient satisfaction and severity of prolapse with POP-Q were assessed using Wilcoxon signed-rank test
Sample size calculation Previous pessary study in our unit has shown the rate of pessary-related complications with follow-up interval of 6-month was 30 only PVC pessary was available Assuming the complication rate of silicone pessary use with 6-month follow-up interval is 10 configuring 80 power of detection 5 of beta error and 20 of dropout rate 140 participants are needed for recruitment
Vaginal pessaries are primarily made of polyvinyl chloride PVC or silicone PVC has been the material of choice for local practice based on its long history in clinical use and cheaper cost A new PVC pessary is inserted at each consultation if vaginal condition is satisfactory In view of the increasing number of POP patients who opt for long term pessary use silicone has emerged as alternative material of choice in recent years Despite being more expensive silicone pessaries can be washed and re-inserted for 20 washes10 years if remained intact and not visibly damaged As silicone pessary is more pliable it can facilitate the process of pessary insertion and removal by squeezing of the pessary to pass through narrow introitus On the other hand it may be more easily compressed by abdominal pressure and dislodged when straining The UK clinical guideline for best practice in the use of vaginal pessaries for POP in 2021 suggested there is no clear preference of offering one type of pessary over another further supported by the latest publication of a multi-centre pessary study in the UK in 2023
The primary objective is to determine the effect of vaginal ring pessary material on pessary complications and patients satisfaction The secondary objectives are to explore the effect of pessary material on procedural pain during pessary exchange as well as prolapse-related symptoms It is hypothesised that silicone pessaries compared to PVC pessaries can reduce the rate of pessary-related complications from 30 to 10 and also result in higher patients satisfaction
This is a single-blinded randomised placebo-controlled trial conducted in the pessary clinic in Princess Margaret Hospital
Participants are assessed for eligibility when they present to pessary clinic for routine pessary care
Participants are recruited and assigned randomly in 11 ratio to receive either
Treatment arm replacement of a new silicone pessary
Control arm replacement of a new PVC pessary Participants are randomly assigned to one of the two groups in 11 ratio Randomization is carried out by an independent statistician according to computer-generated random numbers in random blocks of two four and six allocated by sequentially numbered sealed opaque envelopes When participants are prepared for pessary care inside the examination room the new pessary will be prepared by research assistant outside the examination room according to the allocation result The attending staff will conduct routine pessary care including pessary removal vaginal examination and pessary replacement Participants are not informed of the material of the new pessary Standard patient information leaflet regarding pessary care with hotlines is provided A 6-month follow up appointment will be arranged
Participants will subsequently attend follow up 6 months later A questionnaire will be given by the research assistant before the consultation to enquire for any pessary-related symptoms and their satisfaction on the current pessary During the consultation the attending staff will remove the study pessary and assess the vaginal condition The study is concluded by a short questionnaire and routine pessary care follows subsequently
Data Collection Patient age parity menopausal status stage of prolapse on presentation previous duration of pessary use history of pessary complications are obtained from hospital record as demographic data
Symptoms of pessary-related complications and patients satisfaction are collected by self-administered questionnaires Signs of pessary-related complications are assessed and documented by the attending staff
Statistical Analysis Baseline characteristics and outcomes of PVC pessary group and silicone pessary group are compared using independent t-test Mann-Whitney U test Pearsons chi-square test or Fishers exact test where appropriate
Odds ratio for complications with 95 confidence interval was calculated The within-group changes of patient satisfaction and severity of prolapse with POP-Q were assessed using Wilcoxon signed-rank test
Sample size calculation Previous pessary study in our unit has shown the rate of pessary-related complications with follow-up interval of 6-month was 30 only PVC pessary was available Assuming the complication rate of silicone pessary use with 6-month follow-up interval is 10 configuring 80 power of detection 5 of beta error and 20 of dropout rate 140 participants are needed for recruitment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None