An interventional study of Pessary care, change of pessary in Pelvic Organ Prolapse, sponsored by Princess Margaret Hospital, Hong Kong. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Princess Margaret Hospital, Hong Kong · Not applicable, Interventional, and Treatment
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
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.
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 washes/10 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 1:1 ratio to receive either
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, Pearson's chi-square test or Fisher's 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.
521 studies on the registry are indexed under Pelvic Organ Prolapse; 80 are open to participants now.
This study's planned enrollment of 140 is above the median of 80 across 336 interventional studies indexed under Pelvic Organ Prolapse.
Browse Pelvic Organ Prolapse studies →Princess Margaret Hospital, Hong Kong is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Change to silicon ring pessary of nearest size
Procedure: Pessary care, change of pessary
Change of same PVC ring pessary
Procedure: Pessary care, change of pessary
Insertion of a new pessary by gynaecologist if not contraindicated, silicon or polyvinyl chloride pessary of same size, blinded to patient
Pessary related complications
Patient reported symptoms such as vaginal bleeding, vaginal discharge, pessary dislodgement Physician reported complications such as ulcers formation, vaginitis
Time frame: 6 months
Patient satisfaction
Visual analogue score 1- 10 \[Minimal satisfaction: 1, Maximal satisfaction: 10\]
Time frame: 6 months
Pain during pessary exchange
Visual analogue scale 1- 10 \[Minimal pain: 1, Maximal pain: 10\]
Time frame: 6 months
Prolapse related symptoms
PFDI 20 summary score (Pelvic Floor Disability Index) \[Minimal symptoms: 0 Maximal symptoms: 300\]
Time frame: 6 months
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Start is estimated for Oct 2024; primary completion for Dec 2025, 14 months later.
Of 162 non-industry interventional studies with no phase under Pelvic Organ Prolapse, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's planned 14 months is below that.
Counting every sponsor, half of 179 studies reached it within 23 months; a quarter within 12 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Princess Margaret Hospital, Hong Kong