Pelvic organ prolapse, overactive bladder, urgency incontinence, pessary, antimuscarinic agents, selective ß-3-adrenoceptor-agonist Prolaps, overactive bladder, urgency incontinence, pessary, bladder relaxant
Conditions
Interventions
A pessary [CE 0086] is a vaginal ring, placed in the vagina, to support the pelvic organs. Prolapse of the bladder, uterus and/or rectum can be treated this way, by supporting these organs and keeping
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Women with pelvic organ prolapse (POP), POP-Q stage II–III [28], involving at least the anterior compartment. Prolapse of other compartments may be present, provided that the anterior compartment is at least POP-Q stage II–III.Age =18 yearsAble to complete questionnaires in DutchOAB must be the primary complaintOAB is defined according to the ICS guidelines as urinary urgency, usually accompanied by urinary frequency and nocturia, with or without urgency urinary incontinence [1,2]. Nocturnal polyuria and active urinary tract infection will be ruled out.Prolapse symptoms (bulge symptoms) must be mild or absent (not present, not bothersome, or only somewhat bothersome)Suitable for both PES and OAB-MEDWilling and able to provide written informed consent
Exclusion criteria
Exclusion criteria: Contraindications to antimuscarinic agents AND selective ß-3-adrenoceptor-agonists. To be eligible, women must be able to use at least one of these pharmacological treatment options (antimuscarinic agents and/or selective ß-3-adrenoceptor-agonists).Other medication with anticholinergic effects due to reaching the maximum anticholinergic effect / anticholinergic burden.Unwilling to use either medication or pessary.Presence of nocturnal polyuria and active urinary tract infection.Previous unsuccessful treatment with OAB medication or pessary therapy, or prior treatment with therapies such as percutaneous tibial nerve stimulation (PTNS), intravesical botulinum toxin injections, or sacral neuromodulation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: Reduction in overactive bladder symptoms according to a standardised questionnaire (International Consultation on Incontinence Questionnaire Overactive Bladder: ICIQ-OAB) after 3 months. This questionnaire also evaluates the level of bother of symptoms. The ICIQ-OAB is an internationally validated patient-reported outcome measure, developed by the International Consultation on Incontinence, which assesses the impact of urinary frequency, urgency, urge urinary incontinence, and nocturia on quality of life. The quality of this validation has been classified as level A by the International Consultation on Incontinence, meaning that validity, reliability, and responsiveness have been demonstrated in multiple datasets [30]. A Dutch translation is available via the official ICIQ translation protocol (www.iciq.net) [56]. The MCID for the ICIQ-OAB ranges from 0.5 to 1.4 points based on distribution-based methods and is 1.0 point based on an anchor-based method [49]. The chosen clinically relevant difference of 1.1 points in our sample size calculation falls within this MCID range. The ICIQ-OAB has previously been used as an outcome measure in several comparable clinical studies. Souto et al. used the ICIQ-OAB in a prospective RCT in 75 women with OAB, reporting significant improvement in OAB symptoms in all treatment groups [47]. Sjöström et al. used the ICIQ-OAB in an RCT in women with urgency and mixed incontinence and reported a significant between-group difference of -1.8 points, which is comparable to the clinically relevant difference of 1.1 points used in our sample size calculation [53]. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include OAB reduction after 6 months measured with the ICIQ-OAB questionnaire, subjective cure rate after treatment initiation (PGI-I questionnaire), patient satisfaction (numeric rating scale), patient-reported experiences of treatment, side effects, complications, treatment costs, cost-effectiveness, use of incontinence materials (according to voiding diary), reasons and risk factors for failure/discontinuation of therapy, and Quality adjusted Life Years (QALYs).We define treatment failure as a PGI-I score of 'no change' or ‘worse’ and/or the desire to change treatment arm due to insufficient symptom relief. Patients will also receive validated questionnaires concerning generic and disease-specific quality of life, sexual function and healthcare utilisation at baseline, 4 weeks, 3 months and 6 months after treatment initiation. Pelvic floor muscle function will be documented at baseline and 6 months. At baseline, a POP-Q assessment will be performed.Side effects and complications will be reported during the study period, including pain, voiding problems, bowel problems, discharge, vaginal bleeding, problems with sexual intercourse, dry mouth, dry eyes, gastroesophageal reflux, hypertension, tachycardia, and serious adverse events.Risk factors for discontinuation of therapy will be selected from previously collected patient characteristics such as age, type and stage of prolapse, comorbidities, and side effects. When a patient discontinues therapy, the physician will conduct a semi-structured interview to assess the reason for discontinuation | — |
Countries
Netherlands
Contacts
Public ContactALWM Coolen
Bergman Clinics
Outcome results
None listed