Prospective Observational Prolapse Study

Vaginal Prolapse Clinical Trial

Official title:

Prospective Observational Study With Patient Reported Outcome Measures (PROM) for the Treatment of Vaginal Prolapse: Pessary vs. Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04701047
• Other study ID #: BC-08720-ADP
• Status: Recruiting
• Start date: September 3, 2021
• Est. completion date: January 2028

Study information

• Verified date: December 2023
• Source: University Hospital, Ghent
• Contact: Kessewa Abosi-Appeadu
• Phone: +32 9 332 3774
• Email: kessewa.abosiappeadu[@]ugent.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2028
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• women with a symptomatic vaginal prolapse

• older than 18 years

Exclusion Criteria:

• 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

• not able to understand the Dutch language

• not able to give a written consent

Related Conditions & MeSH terms

• Prolapse
• Uterine Prolapse
• Vaginal Prolapse

Intervention

Device:
• vaginal pessary
insertion and follow up of a vaginal pessary

Procedure:
• Vaginal prolapse surgery
surgery and follow up after vaginal prolapse surgery

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Amount of pessaries tried before current pessary	Number of pessaries that are being fitted before finding a suitable one via a custom made questionnaire.	4 months after initiation of therapy
Other	Amount of pessaries tried before current pessary	Number of pessaries that are being fitted before finding a suitable one via a custom made questionnaire.	8 months after initiation of therapy
Other	Duration of the pessary consultation	Duration of a pessary consultation in minutes.	4 months after initiation of therapy
Other	Duration of the pessary consultation	Duration of a pessary consultation in minutes.	8 months after initiation of therapy
Primary	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.	Baseline, 6 weeks, one year, two years, five years
Primary	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.	Baseline, 6 weeks, one year, two years, five years
Primary	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	Baseline, 6 weeks, one year, two years, five years
Secondary	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	4 months after start of therapy
Secondary	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	8 months after start of therapy
Secondary	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	4 months after initiation of therapy
Secondary	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	8 months after initiation of therapy
Secondary	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……….	4 months after initiation of therapy
Secondary	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……….	8 months after initiation of therapy