The primary aim of this research project is to investigate the prevalence and bother of OAB before and after POP repair surgery and to determine changes in bladder function after surgery. Secondary aim is to identify predictors of persistence,…
ID
Source
Brief title
Condition
- Urinary tract signs and symptoms
- Uterine, pelvic and broad ligament disorders
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters are the presence of bothersome OAB as measured by bladder
diary and validated disease specific questionnaires (UDI, IIQ, ICIQ-FLUTS,
OABSS) and the outcomes of urodynamic studies (presence of detrusor
overactivity (DO), bladder outflow obstruction (BOO)).
Secondary outcome
Secondary parameters are the outcomes of measurement of POP-Q, ultrasound
assesment of bladder wall thickness (BWT) and configuration of urethra and
bladder neck, analysis of urinary biomarkers, and the findings of cystoscopy
(presence of trabeculation).
Background summary
Clinically the relation of overactive bladder (OAB) and pelvic organ prolapse
(POP) is of great significance. The prevalence of POP stage 2 or more varies
from 37% to 50%. A woman*s life-time risk of requiring surgery for POP and/or
urinary incontinence is approximately 11%. Symptoms of 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. All
treatments for POP (surgery, pessaries) show an improvement of OAB complaints.
However, it is unclear what predicts if the OAB symptoms disappear or not after
operation. Persisting or de novo OAB symptoms are strongly correlated with
dissatisfaction with the final results of an operation for POP.
With better knowledge of prevalence of OAB in patients with POP and predictive
factors for the presence of OAB symptoms after surgery, clinicians can better
counsel their patients and possibly offer alternative treatment for OAB such as
anticholinergics before embarking on surgical treatment.
Study objective
The primary aim of this research project is to investigate the prevalence and
bother of OAB before and after POP repair surgery and to determine changes in
bladder function after surgery.
Secondary aim is to identify predictors of persistence, disappearance or de
novo symptoms of OAB after POP repair surgery.
Study design
The study is a single centre prospective observational study performed in the
departments Urology and Gynaecology of the Radboud University Nijmegen Medical
Centre, The Netherlands.
Study burden and risks
Participation in this study is associated with negligible risks and limited
additional burden for patients. Pre- and postoperative evaluations with
completion of questionnaires and bladder diary, pelvic examination, as well as
preoperative urodynamics are standard elements of medical care. The additional
ultrasound, urine sampling and cystoscopy do not require additional clinic
visits, as these can be performed during the planned outpatient clinic visits,
urodynamic investigation and surgery respectively. One extra moment of
follow-up at six months will be planned, which requires one extra clinic visit.
The postoperative urodynamic investigation also requires one extra clinic
visit.
Both urodynamics and cystoscopy do usually not generate major morbidity or
serious complications. Generally, these investigations are associated with
discomfort during the procedure and transient discomfort, dysuria, and a low
risk of urinary tract infection following the procedure. The cystoscopy is
performed under anesthesia before start of the actual surgery and will
therefore not generate any extra discomfort. Due to standard prophylactic use
of antibiotics during surgery no extra risk of urinary tract infection exists.
Bladder wall thickness measurements and assessment of configuration of urethra
and bladder neck using transvaginal ultrasound are non-invasive and minimally
disturbing for the patient.
Urine samples are collected during urodynamic investigation. The urine which is
normally discarded will be collected and stored. This is not inconvenient for
the patient.
Postbus 9101
6500 HB Nijmegen
NL
Postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
- Female patients, age 18 or greater, with a pelvic organ prolapse POP-Q stage II to IV .
- Patient will undergo prolapse repair surgery.
- Patient understands the Dutch written and spoken language.
Exclusion criteria
- Patients who currently use anticholinergic medication.
- Patients with neurological causes of OAB.
- Patients who are pregnant or wish to become pregnant.
- Patients with a history of cancer in the pelvic region, treated with radiotherapy or surgery.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL38563.091.11 |