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| Name | Class |
|---|---|
| Astellas Pharma Inc | INDUSTRY |
| Continentie Stichting Nederland (Continence Foundation The Netherlands) | UNKNOWN |
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Pelvic organ prolapse (POP) is a common problem. Symptoms of overactive bladder (OAB) are present in approximately 50% of patients with POP. For many women the accompanying symptoms of OAB are an important reason for seeking help for their POP. Surgical repair of prolapse may improve OAB complaints. Persisting or de novo OAB symptoms are strongly correlated with dissatisfaction with the final results of an operation for POP.
The primary aim of this research project is to investigate the difference in prevalence (i.e. improvement) of OAB and bothersome OAB symptoms at 6 and 12 months after POP repair surgery. The secondary objectives are to determine changes in bladder function at 6 and 12 months after surgery and to identify predictive factors for persistence, disappearance or de novo symptoms of OAB after POP surgery.
Women who present with POP and who will undergo surgical treatment will be evaluated at baseline before their surgery and will be followed for the duration of one year after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POP surgery | All women who present with POP at the outpatient clinic of our centre and who will undergo prolapse repair surgery will be asked informed consent for participation in this study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre- and postoperative evaluations | Other | At baseline before surgery and at 6 and 12 months after surgery: questionnaires, bladder diary, pelvic examination with additional ultrasound (one extra outpatient clinic visit at 6 months compared to standard care). At baseline before surgery and at 12 months after surgery: urodynamics with additional urine sampling (one extra outpatient clinic visit at 12 months compared to standard care). At time of surgery: additional cystoscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline in prevalence of OAB as measured by bladder diary and validated disease specific questionnaires at 6 months | At baseline before surgery and at 6 months after surgery | |
| The change from baseline of bothersome OAB symptoms as measured by bladder diary and validated disease specific questionnaires at 6 months | The bother of OAB symptoms, measured by validated disease specific questionnaires, will be presented by scores that reflect the degree of severity of the voiding dysfunction. The presence of bothersome OAB symptoms will be dichotomized in patients with symptoms and moderate to severe bother (symptomatic) and patients with absence of symptoms or with only little or no bother (asymptomatic). | At baseline before surgery and at 6 months after surgery |
| The change from baseline in prevalence of OAB as measured by bladder diary and validated disease specific questionnaires at 12 months | At baseline before surgery and at 12 months after surgery | |
| The change from baseline of bothersome OAB symptoms as measured by bladder diary and validated disease specific questionnaires at 12 months | The bother of OAB symptoms, measured by validated disease specific questionnaires, will be presented by scores that reflect the degree of severity of the voiding dysfunction. The presence of bothersome OAB symptoms will be dichotomized in patients with symptoms and moderate to severe bother (symptomatic) and patients with absence of symptoms or with only little or no bother (asymptomatic). | At baseline before surgery and at 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in outcomes of urodynamic studies (presence of detrusor overactivity (DO), bladder outflow obstruction (BOO)) at 12 months | At baseline before surgery and at 12 months after surgery | |
| Change from baseline in POP-Q stage at 6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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All women who present with POP at the outpatient clinic of our centre and who will undergo prolapse repair surgery will be asked informed consent for participation in this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Myrthe M Tijdink, MD | Contact | +31-(0)24-3614726 | m.tijdink@uro.umcn.nl | |
| Mark E Vierhout, MD,PhD | Contact | +31-(0)24-3614726 | m.vierhout@obgyn.umcn.nl |
| Name | Affiliation | Role |
|---|---|---|
| Mark E Vierhout, MD, PhD | Radboud University Medical Center | Principal Investigator |
| John PF Heesakkers, MD, PhD | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Nijmegen Medical Centre | Recruiting | Nijmegen | 6500 HB | Netherlands |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D007854 | Lead |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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Urine
|
| At baseline before surgery, at 6 and 12 months after surgery |
| Change from baseline in outcomes of ultrasound assessment (bladder wall thickness, bladder neck descent, retrovesical angle) at 6 and 12 months | At baseline before surgery, at 6 and 12 months after surgery |
| Cystoscopic assessment of trabeculation | At time of surgery |
| Change from baseline in concentration of urinary biomarkers at 12 months | Concentration of urinary biomarkers: nerve growth factor (NGF), prostaglandin E2 (PGE2) and adenosine triphosphate (ATP) levels in urine normalized against creatinine concentration. | At baseline before surgery and at 12 months after surgery |
| Myrthe M Tijdink, MD |
| Radboud University Medical Center |
| Principal Investigator |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |