|- candidate number||15499|
|- NTR Number||NTR4254|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-okt-2013|
|- Secondary IDs||none |
|- Public Title||The evaluation of pelvic floor muscle tone depending on how the probe was placed.|
|- Scientific Title||The evaluation of bioelectrical activity of pelvic floor muscles depending on probe location.|
|- hypothesis||1. A higher resting and funtional PFM activity is observed in more distal areas from the introitus of the vagina.|
2. A higher resting and funtional PFM activity is observed on the anterior wall of the vagina
|- Healt Condition(s) or Problem(s) studied||Pelvic floor muscles, Electromyography, Vaginal probe|
|- Inclusion criteria||1. Subject's consent to participate in the study,|
2. Attending physician's consent,
3. Nulliparous, healthy woman,
4. Good general well-being.
|- Exclusion criteria||1. Contraindications to measurements (infection, menstruation),|
2. Lack of subject's consent,
3. Gynecological surgeries
4. Worsening of pain ailments during examination,
5. Urinary incontinence
6. Past or present injuries within the pelvis, hip joint or spine,
7.Past or present the occurrence of pregnancy
8. Congenital and inherited anomalies of the reproductive system.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-aug-2013|
|- planned closingdate||30-okt-2013|
|- Target number of participants||100|
|- Interventions||The main objective is to determine how depth of placement of electrodes its influence on functional and resting bioelectrical activity of PFM. Moreover the probe will be placed in two different ways: toward the anterior or posterior wall of the vagina. A secondary objective is to evaluate the correlation between the activity of PFM, which was measured at various areas of vagina|
The target population in this study will be healthy, nulliparous women. Lack of control group.
Participants will need to attend the examination once only. The duration
of the examination will be approximately 30 minutes.
Electromyographic examination of pelvic floor muscles by means of the intravaginal probe OPTIMA 3 (Sugar International, France) with 3 independent, hemispherical electrodes (recording plates).
Measurement of electrical activity of PFM will be assessed in standing position. Prior to measurements, each participant will be instructed how to perform an isolated PFM contraction and take positions used in this study. Resting and functional sEMG activity (in microvolts - ÁV) will be recorded.
|- Primary outcome||The electromyographic examination of pelvic floor muscles by means of intravaginal probe.|
|- Secondary outcome||none|
|- Timepoints||Immediately after all examinations are completed for each patient|
|- Trial web site||none|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Mr Kuba Ptaszkowski |
|- CONTACT for SCIENTIFIC QUERIES||Mr Kuba Ptaszkowski |
|- Sponsor/Initiator ||Public Higher Medical Professional School in Opole|
(Source(s) of Monetary or Material Support)
|- Brief summary||none|
|- Main changes (audit trail)|
|- RECORD||4-okt-2013 - 11-dec-2013|