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Pelvic Floor Rehabilitation for Gynecological Cancer Patients

4. juni 2013 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

100

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Korea, Republikken
      • Seongnam, Korea, Republikken, 463-707
        • Rekruttering
        • Seoul National University Bundang Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: pelvic floor exercise
pelvic floor rehabilitation program with neuromodulation
Adfærdsmæssigt: pelvic floor rehabilitation program with neuromodulation
pelvic floor rehabilitation program with neuromodulation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Amplitude (uV) of motor evoked potential (MEP) evoked by magnetic stimulation on the sacral plexus.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
pelvic floor muscle strength(mmHg)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Seoul National University Bundang Hospital

Efterforskere

  • Ledende efterforsker: Eun Joo Yang, MD, PhD, Seoul National University Bundang Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2013

Primær færdiggørelse (Forventet)

1. juli 2014

Studieafslutning (Forventet)

1. juli 2014

Datoer for studieregistrering

Først indsendt

16. april 2013

Først indsendt, der opfyldte QC-kriterier

4. juni 2013

Først opslået (Skøn)

7. juni 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. juni 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juni 2013

Sidst verificeret

1. juni 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • B-0906/077-010

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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