Prospective Observational Prolapse Study
ConditionVaginal Prolapse
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity Hospital, Ghent
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
women with a symptomatic vaginal prolapse
older than 18 years
Disqualifiers
under 18 years old
undergone a previous treatment with a pessary or surgery for vaginal prolapse
contra-indications for surgery or pessary use
active or passive child wish
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
vaginal pessary
Deviceinsertion and follow up of a vaginal pessary
Vaginal prolapse surgery
Procedure/Surgerysurgery and follow up after vaginal prolapse surgery
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: pessary1 intervention
Group B: surgery1 intervention
Trial outcomes
Primary outcomes
1
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 years2
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 years3
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 yearsSecondary outcomes
1
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 therapy2
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 therapy3
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 therapy4
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 therapyOther outcomes
1
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 therapy2
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 therapy3
Duration of the pessary consultation
Duration of a pessary consultation in minutes.
Time frame
4 months after initiation of therapy4
Duration of the pessary consultation
Duration of a pessary consultation in minutes.
Time frame
8 months after initiation of therapySponsors and contacts
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Source ClinicalTrials.gov