An observational study in Vaginal Prolapse, sponsored by University Hospital, Ghent. Recruiting at 1 site in Belgium. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-15.
Sponsored by University Hospital, Ghent · Observational
The rationale of the study is to investigate the results of a prolapse treatment in adult women with a vaginal prolapse. The investigators will investigate this by taking questionnaires in women undergoing a surgical prolapse repair and in women that are being treated by a vaginal pessary. The objective is to compare the results of the different methods with each other and to observe the evolution of the symptoms in patients undergoing surgery or pessary use. The investigators would also like to discover existing problems in pessary use and adverse effects.
The rationale of the study is to investigate the results of a prolapse treatment in adult women with a vaginal prolapse. The investigators will investigate this by taking questionnaires in women undergoing a surgical prolapse repair and in women that are being treated by a vaginal pessary. The objective is to compare the results of the different methods with each other and to observe the evolution of the symptoms in patients undergoing surgery or pessary use. The investigators would also like to discover existing problems in pessary use and adverse effects.
The questionnaires that will be used are the PFDI-20 (pelvic floor distress inventory), PFIQ-7 (pelvic floor impact questionnaire), PISQ-9 (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire) and a custom-made questionnaire to further investigate the behavior towards pessary use of our patients and the adverse effects they are dealing with. The questionnaires will be taken before the treatment has started, 6 weeks post treatment start, one-year post treatment start, two years post treatment start and 5 years post treatment start. A POP-Q (Pelvic Organ Prolapse Quantification) investigation will be performed to estimate the degree of vaginal prolapse before the start of the treatment. Since clinical follow up is not necessarily needed after one year for the women who undergo surgery, their questionnaires will be taken via telephone or e-mail. For women that are being treated with pessaries the investigators will also take our custom-made questionnaire at 4 and 8 months after starting the treatment.
The investigators would like to recruit 100 women for this study, older than 18 years old who have not undergone a previous treatment with a pessary or surgery for vaginal prolapse. Another exclusion criterium are women who still have a child wish and women who have contraindications for surgery. The investigators will also exclude women who don't speak Dutch or women who cannot give a written consent.
The investigators hypothesize that woman being treated with one year of pessary use are overall not having more symptoms than woman that underwent a surgery. The investigators hypothesize that woman being treated with five years of pessary use are overall having less symptoms than woman that underwent a surgery.
111 studies on the registry are indexed under Uterine Prolapse; 18 are open to participants now.
This study's planned enrollment of 200 is above the median of 99 across 34 observational studies indexed under Uterine Prolapse.
Browse Uterine Prolapse studies →University Hospital, Ghent is the lead sponsor of 689 studies on the registry; 160 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
The research population will include women above the age of 18 years old who consult the department of urology or the department of gynaecology at the university hospital of Ghent with symptoms of vaginal prolapse. The patients will be recruited by their attending physician. There will be no exclusion on the degree of vaginal prolapse. All symptomatic prolapses will be included in this study. Exclusion criteria will be having undergone a previous treatment with a pessary or surgery for vaginal prolapse, contraindications for surgery or pessary use, active of passive child wish, not able to understand the Dutch language and not able to give a written consent.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vaginal prolapse being treated by pessary
Device: vaginal pessary
Vaginal prolapse being treated by surgical repair
Procedure: Vaginal prolapse surgery
insertion and follow up of a vaginal pessary
surgery and follow up after vaginal prolapse surgery
Change in Pelvic Floor Disability Index (PFDI-20)
Change in scores on the short-form version of the Pelvic Floor Distress Inventory (PFDI). It is a health-related quality of life questionnaire for women with pelvic floor conditions to fill out.
Time frame: Baseline, 6 weeks, one year, two years, five years
Change in pelvic floor impact questionnaire (PFIQ-7)
Change in scores on the shortened version of the Pelvic Floor Impact Questionnaire (PFIQ). It is a health-related quality of life questionnaire for women with pelvic floor conditions to fill out.
Time frame: Baseline, 6 weeks, one year, two years, five years
Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
Change in scores on the short form of the PISQ-31 that evaluates sexual function in women with urinary incontinence and/or pelvic organ prolapse
Time frame: Baseline, 6 weeks, one year, two years, five years
Subjective self-reported satisfaction scores for pessary use as measured via a custom-made Likert scale questionnaire
Study participants are asked how satisfied they are with their pessary use at 4 months after the initiation of pessary use. Participants can choose one of five graded answers on the Likert scale: 5 Very satisfied 4 satisfied 3 neutral 2 unsatisfied 1 very unsatisfied
Time frame: 4 months after start of therapy
Subjective self-reported satisfaction scores for pessary use as measured via a custom-made Likert scale questionnaire
Study participants are asked how satisfied they are with their pessary use at 8 months after the initiation of pessary use. Participants can choose one of five graded answers on the Likert scale: 5 Very satisfied 4 satisfied 3 neutral 2 unsatisfied 1 very unsatisfied
Time frame: 8 months after start of therapy
Self-reported behavior and patient preferences towards pessary use via a custom-made questionnaire
frequency of pessary use, subjective reasons why not to wear a pessary and alternative treatment considerations as assessed by open-ended and yes or no type questions
Time frame: 4 months after initiation of therapy
Self-reported behavior and patient preferences towards pessary use via a custom-made questionnaire
frequency of pessary use, subjective reasons why not to wear a pessary and alternative treatment considerations as assessed by open-ended and yes or no type questions
Time frame: 8 months after initiation of therapy
Subjective self-reported adverse effects of pessary use as measured via a custom-made questionnaire
Participants will be asked if they experienced side effects that they feel has been caused by pessary use via a custom-made questionnaire: The most commonly anticipated answers have been listed with the option of patients describing other potential adverse events (shown below): * No side effects * It feels uncomfortable * It gives an itchy/burning sensation * More vaginal discharge * Other..........
Time frame: 4 months after initiation of therapy
Subjective self-reported adverse effects of pessary use as measured via a custom-made questionnaire
Participants will be asked if they experienced side effects that they feel has been caused by pessary use via a custom-made questionnaire: The most commonly anticipated answers have been listed with the option of patients describing other potential adverse events (shown below): * No side effects * It feels uncomfortable * It gives an itchy/burning sensation * More vaginal discharge * Other..........
Time frame: 8 months after initiation of therapy
Amount of pessaries tried before current pessary
Number of pessaries that are being fitted before finding a suitable one via a custom made questionnaire.
Time frame: 4 months after initiation of therapy
Amount of pessaries tried before current pessary
Number of pessaries that are being fitted before finding a suitable one via a custom made questionnaire.
Time frame: 8 months after initiation of therapy
Duration of the pessary consultation
Duration of a pessary consultation in minutes.
Time frame: 4 months after initiation of therapy
Duration of the pessary consultation
Duration of a pessary consultation in minutes.
Time frame: 8 months after initiation of therapy
Plan to share: Undecided
No publications or documents are linked to this record.
Started Sep 2021 (actual). Primary completion is estimated for Jan 2028, 76 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.