Pelvic Floor Rehabilitation for Gynecological Cancer Patients
4 juni 2013 uppdaterad av: Eun Joo Yang, Seoul National University Bundang Hospital
Neuromodulation System for Pelvic Floor Dysfunction Based on the Myo-neurophysiological Assessment for Gynecological Cancer Patients
As cancer treatment improves, the cancer survivor's quality of life and level of function have gained increasing importance.
Pelvic floor function is directly affected by gynecological cancer and treatment, and pelvic floor dysfunction (PFD) can severely affect a patient's life.
PFD negatively affects health-related quality of life (HRQOL).
Evaluation of PFD provides information about the disease burden and treatment-related effects directly from the patient's perspective and informs clinical decision-making.
The pelvic floor musculature and sacral nerves are not easily accessible, and it is difficult to test them.
Several functional assessments have been used to evaluate pelvic floor dysfunction; however, reports on methodology are sparse, and consensus on their use is lacking.
Research on functional outcomes is highly complex and, consequently, must be addressed in a comprehensive framework.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Patients with cervical or colorectal cancer who underwent surgery or radiotherapy are recruited for the study.
- PFM strength is measured using a perineometer (BioCon-200,McubeTechnologyCompany,Seoul,Korea). Vaginal pressure is measured using a vaginal silicon pressure sensor (cmH2O; sensitivity0.06kPa,sensitivity 5mV, threshold1.5V).
- The motor evoked potentials (MEPs) from the pelvic floor are obtained by sacral and transcranial magnetic stimulation using a Magstim 200 stimulator (Magstim Co., Whitland, Wales, UK). Patients are instructed to lie in the left lateral decubitus position,intra-anal sponge electrode (Dantec,Skovlund, Denmark)was lubricated and gently inserted into the anal canal.
- Monophasic single pulses of magnetic stimuli were delivered to the vertex corresponding to the primary motor center in the precentral gyrus using a double-cone coil(9902-00,Magstim). A figure-eight coil(9762-00,Magstim)was used to stimulate the dorsolateral area of the sacrum corresponding to the exit of the sacral cortical facilitation
- We measured the latency, amplitude, and excitability threshold(ET) of MEPs detected in pelvic floor muscles with and without facilitation. The excitability threshold at rest(RET) is defined as the lowest intensity that produced MEP responses of 100μV For optimal facilitation, we measure the latency of the MEPs with minimal contraction (10% of MVC) with RET intensity and amplitude with a moderate contraction
- Patient-reported HRQOL Quality of life General and condition-specific aspects of HRQOL were assessed using the EORTC QLQ-C30 questionnaires.
Studietyp
Interventionell
Inskrivning (Förväntat)
100
Fas
- Fas 2
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Seongnam, Korea, Republiken av, 463-707
- Rekrytering
- Seoul National University Bundang Hospital
-
Kontakt:
- Eun Joo Yang, MD. PhD
- Telefonnummer: 82-787-7734
- E-post: graceloves@gmail.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
Inclusion Criteria:
- Women with gynecological cancer who had radical hysterectomy and pelvic lymph node dissection
Exclusion Criteria:
- infectious diseases of the urinary tract and vagina
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: pelvic floor exercise
pelvic floor rehabilitation program with neuromodulation
|
pelvic floor rehabilitation program with neuromodulation
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Amplitude (uV) of motor evoked potential (MEP) evoked by magnetic stimulation on the sacral plexus.
Tidsram: 1week after intervention
|
We measure the amplitude (uV) of motor evoked potential (MEP) evoked by magnetic stimulation on the sacral plexus at the baseline and 1wk after intervention.
Then we compare the change of the amplitude (1 wk after intervention-baseline)between two groups.
|
1week after intervention
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
pelvic floor muscle strength(mmHg)
Tidsram: baseline, up to 1week after intervention
|
We measure the pelvic floor muscle strength using perometer (mmHg)at baseline and 1 wk after intervention then compare the change of pelvic floor muscle strength(1wk after intervention-baseline) between two groups.
|
baseline, up to 1week after intervention
|
|
latency (ms) of MEP (motor evoked potential)
Tidsram: baseline, up to 1week after intervention
|
We measure the latency (ms) of MEP evoked by magnetic stimulation on the sacral plexus and compare the change of latency (1wk after intervention-baseline)between two groups
|
baseline, up to 1week after intervention
|
|
Functional score and symptom scale of QuEORTC QLQ-C-30,EORTC CX-24
Tidsram: baseline, up to 1week after intervention
|
We evaluate the functional score and symptom scale with EORTC QLQ-C30, EORTC QLQ-CX24 questionnaires and compare the change between two groups.
|
baseline, up to 1week after intervention
|
|
Total Bladder, bowel,sexual functional scores measured by the pelvic floor questionnaire
Tidsram: baseline, up to 1week after intervention
|
We evaluated the bladder, bowel, sexual functional scores with the interviewer-administered pelvic floor questionnaire at baseline and 1wk after intervention then compare the change of the scores between two groups
|
baseline, up to 1week after intervention
|
|
Hiatal dimension (mm) and levator plate angle (º) on maximal pelvic floor muscle contraction measure with ultrasound
Tidsram: baseline, up to 1week after intervention
|
We measure the Hiatal dimension (mm) and levator plate angle (º) on maximal pelvic floor muscle contraction using ultrasound with curved transducer (3.5-6 MHz)at baseline and 1 wk after intervention and compare the change between two groups
|
baseline, up to 1week after intervention
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Eun Joo Yang, MD, PhD, Seoul National University Bundang Hospital
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2013
Primärt slutförande (Förväntat)
1 juli 2014
Avslutad studie (Förväntat)
1 juli 2014
Studieregistreringsdatum
Först inskickad
16 april 2013
Först inskickad som uppfyllde QC-kriterierna
4 juni 2013
Första postat (Uppskatta)
7 juni 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
7 juni 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 juni 2013
Senast verifierad
1 juni 2013
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- B-0906/077-010
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .