Prospective Observational Prolapse Study

Study Overview
=================
Brief 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.

Detailed 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.

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

Conditions
-----------------
Vaginal Prolapse

Intervention / Treatment
-----------------
* Device: vaginal pessary
* Procedure: Vaginal prolapse surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pessary<br>Vaginal prolapse being treated by pessary | Device: vaginal pessary<br>* insertion and follow up of a vaginal pessary<br>|
| surgery<br>Vaginal prolapse being treated by surgical repair | Procedure: Vaginal prolapse surgery<br>* surgery and follow up after vaginal prolapse surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |