A. Determine the placement of the Maple-probe in relation to the anatomy of the pelvic floor musculature.B. Determine the normal rest tone of the pelvic floor musculatureC. Determine the normal activity of the pelvic floor musculatureD. Determine…
ID
Source
Brief title
Condition
- Genitourinary tract disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To detect significant differences in measurement with the common used probes
and the MAPLe.
To validate the MAPLe.
To improve complaints of Urgency/Frequency and/or Urge Urinary Incontinence
Secondary outcome
Quality of Life
Background summary
Since the introduction of the manometric probe used as a perineometer by Kegel
(1), many electrodes have been developed for intravaginal and intra-anal
electrostimulation and biofeedback training in the treatment of pelvic floor
dysfunction. Intravaginal and intra-anal electrostimulation and biofeedback
training are used for treatment of urinary urge- and stress incontinence, anal
dysfunction, and sexual dysfunction. For optimal treatment, knowledge of the
structures that are the main targets in stimulating and in biofeedback training
is needed. This knowledge of both the anatomy of the pelvic floor and
physiological aspects should result in optimal design of probes. However, lack
of uniformity in description of the anatomy per se, the nomenclature of the
pelvic floor (2-4), and stimulation techniques is hampering such a design (5*
8). Moreover, the available, commonly used probes have been developed
empirically. We developed a new probe, which has been applied for a patent
In our opinion the ideal probe must be:
1. registering;
* vaginal: the puborectal muscle, the external urethral sphincter;
* anal: the puborectal muscle, the anal external sphincter, the levator ani;
2. stimulating the structures we want to stimulate: nerves or muscles;
3. shaped and sized adapted to the local anatomy (not vice versa);
4. comfortable for the patient;
5. maintaining its position;
6. the reference electrode should be incorporated;
7. suitable for sterilization;
8. durable;
9. containing rings and plates.
Study objective
A. Determine the placement of the Maple-probe in relation to the anatomy of
the pelvic floor musculature.
B. Determine the normal rest tone of the pelvic floor musculature
C. Determine the normal activity of the pelvic floor musculature
D. Determine the normal straining activity of the pelvic floor musculature
E. Determine the differences between healthy volunteers and
patients regarding pelvic floor function
F. Determine diference in outcome in patients treated with the
commerccible available probes and the MAPLe
G. Determine the differences in outcome between EMG values of
the MAPLe and EMG values of needle EMG
Study design
By way of a message on the Albinesnet and /or Cicero 100 healthy volunteers
will be called. these healthy volunteers are only able to participate in this
study when they did not search for help or use any medication regarding
complaints of micturition, defecation and/or sexual dysfunction. These healthy
volunteers will be asked if they are willing to undergo an invasive diagnostic
investigation of the pelvic floor function with the Maple -probe. soem
volunteers will be asked to undergo a MRI to investigate placement of probe and
elektrodes.The volunteerse may apply by mail. After registration , the
department of urology will send them the patient information and the informed
consent.Healthy volunteers will allot a code to a fictiv number.
volunteers will be measured with the MAPLE and than with needle EMG
First patients will be measured with the commerciable available probe, than
with the MAPle. Informed consent will be signed by patients..
Intervention
NA
Study burden and risks
Na
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Patients with pelvic floor dysfunction
Exclusion criteria
women with neurological diseases
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL17997.058.08 |