Main objective: To evaluate the outcomes of the PelFIs in patients with OAB; the relation to the clinical efficacy of antimuscarinic treatment and to hyperactivity of the pelvic floor muscles.Secondary objectives:• To asses the efficacy of…
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints:
PelFIs questionnaire
The patient assessment of the degree of complaints due to pelvic floor
dysfunction will be performed using the validated PelFIs questionnaire at all
visits.
Micturition diary
Time of micturition, urgency and incontinence, pad use and volumes voided per
micturition will be recorded by the patients in the micturition diary. In
addition, time of getting up and going to bed will be recorded. Also used
incontinence pads wil be collected during 24 hours.
Padtest
Used incontinence pads wil be collected during 24 hours.
Pelvic floor examination (PFE)
A qualitative as well as quantitative examination of the pelvic floor with use
of biofeedback will be performed by a qualified physiotherapist at visit 2 and
5.
Secondary outcome
Nvt.
Background summary
Urge, urge-incontinence and frequency symptoms due to an overactive bladder
(OAB) are commonly treated with muscarinic receptor blockers. In some studies,
however, it appears that a proportion of the patients do not have a sufficient
clinical effect with pharmacotherapy. The cause of this phenomenon is not yet
known. Recent observations in our department of urology have lead to the
hypothesis that clinical symptoms of overactive bladder may be induced by
excessive tension in the pelvic floor and the inability of the patient to relax
his or her pelvic floor muscles.
The PelFIs is a validated instrument measuring the degree of complaints due to
pelvic floor dysfunction, containing eleven different symptom domains, and for
each domain an overall Quality of Life (QoL) and Visual Analogue Scale (VAS)
item 1. The PelFIs is a new, practical and conceptually clear questionnaire,
which focuses on micturition, defecation and/or sexual dysfunction related to
pelvic floor dysfunction. The PelFIs may be a helpful tool to determine the
overactivity of the pelvic floor muscles. However the outcomes of the PelFIs
have not been compared to other diagnostic tests for overactivity of the pelvic
floor. Also the absence of a *golden standard* makes it difficult to interpret
the outcome of the PelFIs.
If we could determine which questions of the PelFIs give a high score in
patients with overactivity of the pelvic floor musles, we could use a short
version of the PelFIs in patients with OAB to determine overactivity of the
pelvic floor muscles and adjust therapy to these findings.
Aim of this research is to evaluate the outcomes of the PelFIs in patients with
OAB. Can the PelFIs be used as a prognostic tool for choice of therapy in
patients with OAB?
Study objective
Main objective:
To evaluate the outcomes of the PelFIs in patients with OAB; the relation to
the clinical efficacy of antimuscarinic treatment and to hyperactivity of the
pelvic floor muscles.
Secondary objectives:
• To asses the efficacy of antimuscarinic treatment (solifenacin) as measured
by 3-day patient diary (micturition, urge, incontinence) and the padtest. We
will use the results of the patient diary and the padtest to objectively
determine if the treatment is successful or not.
• To correlate the results of the PFE to (un)successful treatment. Is there a
higher rate of overactivity of the pelvic floor muscles in the patients with
OAB who do not respond to pharmacological treatment?
• To correlate the results of the PelFIs questionnaire and PFE. Do patients
with overactivity of the pelvic floor score higher on certain questions?
Study design
Prospective, single arm multicentre study with a flexible dose of solifenacin
for 12 weeks. Assessment of pelvic floor condition by the PelFIs questionnaire
and pelvic floor examination (PFE). Assessment of overactive bladder symptoms
by a patient diary and padtest.
Study burden and risks
During 12 weeks 4 contactmoments. Two times physical and pelvic floor
examination. Three times the PelFIs questionnaire and the micturation dairy
will be filled in. Two times used pads will be collected during 24 hours.
During the 12 weeks treatment with solifenacine.
Albinusdreef 2
2333 ZA, Leiden
Nederland
Albinusdreef 2
2333 ZA, Leiden
Nederland
Listed location countries
Age
Inclusion criteria
1. Male or female patient aged 18 and older.
2. Written informed consent has been obtained.
3. Patient is willing and able to complete the PelFIs questionnaire and diaries correctly.
4. Symptoms of overactive bladder: urinary frequency is 8 or more times per 24 hours and at least 3 urgency or urge incontinence episodes per 24 hours.
5. Not treated with conservative or pharmacological treatment for at least 3 weeks prior to the study.
Exclusion criteria
1. Total daily urine volume > 3000 ml as verified in the micturition diary.
2. Women of childbearing potential who are pregnant or intend to become pregnant during the study or who will be lactating during the study.
3. Clinically significant outflow obstruction.
4. Significant post void residual volume (PVR>200ml) measured by abdominal ultrasound.
5. Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor.
6. Evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs.
7. Uncontrolled narrow angle glaucoma, urinary or gastric retention or any other medical condition which makes the use of anticholinergics contra-indicated.
8. Known or suspected hypersensitivity to solifenacin or other anticholinergics or lactose.
9. Any clinically significant condition, which in the opinion of the investigator makes the patient unsuitable for the study.
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 | NL26101.058.09 |