Urinary Bladder, OveractiveSOAPNCT01540214
Study of Overactive Bladder in Women With Prolapse
An observational study of Urinary Bladder, Overactive and Pelvic Organ Prolapse, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Bladder, Overactive, Pelvic Organ Prolapse
- What is being tested?
- Pre- and postoperative evaluations
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2012to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Female patients, age 18 or greater, with a pelvic organ prolapse stage II to IV as defined by the POP-Q system
- Patient is a candidate for prolapse repair surgery (as based on history and physical examination)
- Patient is capable to fill out bladder diaries and questionnaires and understands the Dutch written and spoken language
Who cannot join
- Patients who currently use anticholinergic medication
- Patients with neurological causes of OAB
- Patients who are pregnant
- Patients with a history of cancer in the pelvic region, treated with radiotherapy or surgery
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Nijmegen Medical Centre
Nijmegen, 6500 HB
Myrthe M Tijdink, MD, +31-(0)24-3614726, m.tijdink@uro.umcn.nl
Myrthe M Tijdink, MD
About this study
Official title: Prevalence of Overactive Bladder (OAB) in Patients With Pelvic Organ Prolapse (POP) and Predictors of Symptoms of OAB After Surgical Correction of POP
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.
- Conditions
- Urinary Bladder, Overactive, Pelvic Organ Prolapse
- Being tested
- Pre- and postoperative evaluations
- Keywords
- Urinary Bladder, Overactive, Pelvic Organ Prolapse, Gynecologic Surgical Procedures, Urodynamics
- Medical subject headings
- Urinary Bladder, Overactive, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre- and postoperative evaluationsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Pre- and postoperative evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in prevalence of OAB as measured by bladder diary and validated disease specific questionnaires at 6 months
Measured: 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).
Measured: 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
Measured: 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).
Measured: At baseline before surgery and at 12 months after surgery
Secondary outcomes (5)
Change from baseline in outcomes of urodynamic studies (presence of detrusor overactivity (DO), bladder outflow obstruction (BOO)) at 12 months
Measured: At baseline before surgery and at 12 months after surgery
Change from baseline in POP-Q stage at 6 and 12 months
Measured: 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
Measured: At baseline before surgery, at 6 and 12 months after surgery
Cystoscopic assessment of trabeculation
Measured: 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.
Measured: At baseline before surgery and at 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionJun 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder, OveractiveStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc, Continentie Stichting Nederland (Continence Foundation The Netherlands)
- Responsible party
- Sponsor
- Investigators
- Mark E Vierhout, MD, PhD, Principal investigator, Radboud University Medical CenterJohn PF Heesakkers, MD, PhD, Principal investigator, Radboud University Medical CenterMyrthe M Tijdink, MD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540214
- Sponsor's protocol ID
- 2011/456
- Acronym
- SOAP
- Status last verified
- Dec 2012
- First submitted
- 10 Feb 2012
- Last updated
- 7 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Overactive Bladder (OAB) in Patients With Pelvic Organ Prolapse (POP) and Predictors of Symptoms of OAB After Surgical Correction of POP
- ClinicalTrials.gov ID
- NCT01540214
- Acronym / sponsor ID
- SOAP / 2011/456
- Conditions
- Urinary Bladder, Overactive, Pelvic Organ Prolapse
- Keywords
- Urinary Bladder, Overactive, Pelvic Organ Prolapse, Gynecologic Surgical Procedures, Urodynamics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc, Continentie Stichting Nederland (Continence Foundation The Netherlands)
- Study start
- Feb 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 28 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| POP surgery | – | Other: Pre- and postoperative evaluationsAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Female patients, age 18 or greater, with a pelvic organ prolapse stage II to IV as defined by the POP-Q system
- Patient is a candidate for prolapse repair surgery (as based on history and physical examination)
- Patient is capable to fill out bladder diaries and questionnaires and understands the Dutch written and spoken language
Key exclusion criteria (4 listed)
- Patients who currently use anticholinergic medication
- Patients with neurological causes of OAB
- Patients who are pregnant
- Patients with a history of cancer in the pelvic region, treated with radiotherapy or surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre- and postoperative evaluationsAt 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. | Other | POP surgery |
Primary outcome
The change from baseline in prevalence of OAB as measured by bladder diary and validated disease specific questionnaires at 6 months
Time frame: 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
Time frame: At baseline before surgery and at 6 months after surgery
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).
The change from baseline in prevalence of OAB as measured by bladder diary and validated disease specific questionnaires at 12 months
Time frame: 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
Time frame: At baseline before surgery and at 12 months after surgery
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).
5 secondary outcomes
Change from baseline in outcomes of urodynamic studies (presence of detrusor overactivity (DO), bladder outflow obstruction (BOO)) at 12 months
Time frame: At baseline before surgery and at 12 months after surgery
Change from baseline in POP-Q stage at 6 and 12 months
Time frame: 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
Time frame: At baseline before surgery, at 6 and 12 months after surgery
Cystoscopic assessment of trabeculation
Time frame: At time of surgery
Change from baseline in concentration of urinary biomarkers at 12 months
Time frame: At baseline before surgery and at 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark E Vierhout, MD, PhD principal investigator
Radboud University Medical Center
John PF Heesakkers, MD, PhD principal investigator
Radboud University Medical Center
Myrthe M Tijdink, MD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Bladder, Overactive and Pelvic Organ Prolapse, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Myrthe M Tijdink, MD (+31-(0)24-3614726, m.tijdink@uro.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline in prevalence of OAB as measured by bladder diary and validated disease specific questionnaires at 6 months (time frame: At baseline before surgery and at 6 months after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2013.