Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04701047

Prospective Observational Prolapse Study

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Vaginal Prolapse Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Urogenital Diseases Uterine Diseases Uterine Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Location status: Recruiting

Location contact

Eline Meireson

CONTACT

[email protected]

09/332 78 17

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vaginal pessary

Device

insertion and follow up of a vaginal pessary

Vaginal prolapse surgery

Procedure

surgery and follow up after vaginal prolapse surgery

Primary outcomes

  1. Change in Pelvic Floor Disability Index (PFDI-20)

    Time frame: Baseline, 6 weeks, one year, two years, five years

    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.

  2. Change in pelvic floor impact questionnaire (PFIQ-7)

    Time frame: Baseline, 6 weeks, one year, two years, five years

    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.

  3. Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)

    Time frame: Baseline, 6 weeks, one year, two years, five years

    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

Secondary outcomes

  1. Subjective self-reported satisfaction scores for pessary use as measured via a custom-made Likert scale questionnaire

    Time frame: 4 months after start of therapy

    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

  2. Subjective self-reported satisfaction scores for pessary use as measured via a custom-made Likert scale questionnaire

    Time frame: 8 months after start of therapy

    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

  3. Self-reported behavior and patient preferences towards pessary use via a custom-made questionnaire

    Time frame: 4 months after initiation of therapy

    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. Self-reported behavior and patient preferences towards pessary use via a custom-made questionnaire

    Time frame: 8 months after initiation of therapy

    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

  5. Subjective self-reported adverse effects of pessary use as measured via a custom-made questionnaire

    Time frame: 4 months after initiation of therapy

    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……….

  6. Subjective self-reported adverse effects of pessary use as measured via a custom-made questionnaire

    Time frame: 8 months after initiation of therapy

    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……….

Other outcomes

  1. Amount of pessaries tried before current pessary

    Time frame: 4 months after initiation of therapy

    Number of pessaries that are being fitted before finding a suitable one via a custom made questionnaire.

  2. Amount of pessaries tried before current pessary

    Time frame: 8 months after initiation of therapy

    Number of pessaries that are being fitted before finding a suitable one via a custom made questionnaire.

  3. Duration of the pessary consultation

    Time frame: 4 months after initiation of therapy

    Duration of a pessary consultation in minutes.

  4. Duration of the pessary consultation

    Time frame: 8 months after initiation of therapy

    Duration of a pessary consultation in minutes.

Study contacts

Contact information is provided by the study sponsor or research team.

Kessewa Abosi-Appeadu

CONTACT

[email protected]

+32 9 332 3774

Steffi Van Wessel

CONTACT

[email protected]

+32 9 332 0289

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Jan 8, 2021
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.