Effect of Pelvic Floor Stimulation on the Pelvic Floor Function in Cervical Cancer Patients With Type III Hysterectomy
13 maart 2018 bijgewerkt door: Wang Jianliu
The purpose of this study is to investigate the effect of electric stimulation on the pelvic floor function in cervical cancer patients with type III hysterectomy.
Studie Overzicht
Toestand
Onbekend
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This is a prospective, multi center, open, randomized, controlled clinical trial.
All cervical carcinoma patients who undergo type III hysterectomy in the hospitals involved in this study were recruited.
5-7 days postoperative, those who meet the inclusion criteria and without the exclusion criteria and sign the consent were randomized grouped of intervention and control objective by 1:1.
At the same time, according to the research hospital, menopausal status (menopause vs menopause) and surgery approach (laparoscopic vs open)，they were further stratified randomly.
Patients in the intervention group received electrical stimulation treatment based on conventional clinical nursing, while patients in control group only receive routine clinical care.
Except for the treatment of electrical stimulation, other research procedures is the same in the two groups.
The recovery rate of urination function, pelvic floor function and life quality of the two group is compared.
Studietype
Ingrijpend
Inschrijving (Verwacht)
208
Fase
- Niet toepasbaar
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 60 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
Inclusion Criteria:
- Patients diagnosed as cervical squamous cell carcinoma on Ⅰa2, Ib1 or Ⅱa1 stage
- Type III hysterectomy
- There are pathological results showing that cancer resection clean and no distant metastasis,Specifically as follows:Lymph nodes(-);cancer foci invasion depth <1/2;Lymphatic space(-);Vaginal stump(-);differentiation G1-2.
- Patients agreed to the study, informed consent
Exclusion Criteria:
- Radiotherapy and chemotherapy before surgery
- Reserved nerve in the surgery
- Urinary system damage
- POP(Pelvic Organ Prolapse stage)>II stage before surgery
- Moderate above stress urinary incontinence(SUI) before surgery(1 hours urine pad test>=10g)
- Urinary retention before surgery
- Severe constipation or difficult defecation before surgery
- There are uncontrolled epilepsy, central nervous system disease or mental disorder history in patients.The clinical severity of these diseases Influence clinical research compliance,judging by the researcher.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Electric Stimulation Treatment
Patients in the intervention group were treated with electric stimulation based on the routine clinical nursing.
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Electrical stimulation program: frequency: 1/4/Hertz (HZ), pulse width: 270/230/270 μs, time: 30min.
Electrode piece: 50*50mm sticky electrode plate.
Position: an electrode piece is placed in the S3, and an electrode piece is placed in the bladder region.Current intensity adjusted according to the patient's tolerance, the maximum current intensity of the pain was not appropriate, generally not more than 100milliampere(mA).Devices PHENIX USB 8.
Andere namen:
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Geen tussenkomst: control group
patients in this group only received routine clinical nursing without electric stimulation
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Urination function recovery rate
Tijdsspanne: From 14 days to 24 months after operation
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From 14 days to 24 months after operation
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Number of participants with recovery of defecation function and urinary function after III hysterectomy
Tijdsspanne: From 14 days to 24 months after operation
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From 14 days to 24 months after operation
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Quality of life Questionnaire
Tijdsspanne: From 14 days to 24 months after operation
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From 14 days to 24 months after operation
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Overall Survival
Tijdsspanne: From 14 days to 24 months after operation
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The overall survival (OS) in cervical cancer patients after 3 years' III hysterectomy after comparison of pelvic floor rehabilitation therapy and control group
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From 14 days to 24 months after operation
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Disease-free survival
Tijdsspanne: From 14 days to 24 months after operation
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Comparison of pelvic floor rehabilitation treatment group and control group of cervical cancer patients with type III hysterectomy 3 years disease-free survival (DFS)
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From 14 days to 24 months after operation
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: Wang J liu, Doctor, Peking University People's Hospital Ob and Gy
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Plotti F, Angioli R, Zullo MA, Sansone M, Altavilla T, Antonelli E, Montera R, Damiani P, Benedetti Panici P. Update on urodynamic bladder dysfunctions after radical hysterectomy for cervical cancer. Crit Rev Oncol Hematol. 2011 Nov;80(2):323-9. doi: 10.1016/j.critrevonc.2010.12.004. Epub 2011 Jan 31.
- Griffenberg L, Morris M, Atkinson N, Levenback C. The effect of dietary fiber on bowel function following radical hysterectomy: a randomized trial. Gynecol Oncol. 1997 Sep;66(3):417-24. doi: 10.1006/gyno.1997.4797.
- Raspagliesi F, Ditto A, Fontanelli R, Zanaboni F, Solima E, Spatti G, Hanozet F, Vecchione F, Rossi G, Kusamura S. Type II versus Type III nerve-sparing radical hysterectomy: comparison of lower urinary tract dysfunctions. Gynecol Oncol. 2006 Aug;102(2):256-62. doi: 10.1016/j.ygyno.2005.12.014. Epub 2006 Jan 30.
- Jackson KS, Naik R. Pelvic floor dysfunction and radical hysterectomy. Int J Gynecol Cancer. 2006 Jan-Feb;16(1):354-63. doi: 10.1111/j.1525-1438.2006.00347.x.
- Sood AK, Nygaard I, Shahin MS, Sorosky JI, Lutgendorf SK, Rao SS. Anorectal dysfunction after surgical treatment for cervical cancer. J Am Coll Surg. 2002 Oct;195(4):513-9. doi: 10.1016/s1072-7515(02)01311-x.
- Axelsen SM, Petersen LK. Urogynaecological dysfunction after radical hysterectomy. Eur J Surg Oncol. 2006 May;32(4):445-9. doi: 10.1016/j.ejso.2006.01.017. Epub 2006 Mar 3.
- Butler-Manuel SA, Summerville K, Ford A, Blake P, Riley AJ, Sultan AH, Monga AK, Stanton SL, Shepherd JH, Barton DP. Self-assessment of morbidity following radical hysterectomy for cervical cancer. J Obstet Gynaecol. 1999 Mar;19(2):180-3. doi: 10.1080/01443619965552.
- Manchana T, Sirisabya N, Lertkhachonsuk R, Worasethsin P, Khemapech N, Sittisomwong T, Vasuratna A, Termrungruanglert W, Tresukosol D. Long term complications after radical hysterectomy with pelvic lymphadenectomy. J Med Assoc Thai. 2009 Apr;92(4):451-6.
- Sansone M, Plotti F, Panici PB. Long-term lower urinary tract dysfunction after radical hysterectomy in patients with early postoperative voiding dysfunction. Int Urogynecol J. 2010 Oct;21(10):1309-10; author reply 1311-2. doi: 10.1007/s00192-010-1206-1. Epub 2010 Jun 23. No abstract available.
- Barnes W, Waggoner S, Delgado G, Maher K, Potkul R, Barter J, Benjamin S. Manometric characterization of rectal dysfunction following radical hysterectomy. Gynecol Oncol. 1991 Aug;42(2):116-9. doi: 10.1016/0090-8258(91)90329-4.
- Ye S, Yang J, Cao D, Lang J, Shen K. A systematic review of quality of life and sexual function of patients with cervical cancer after treatment. Int J Gynecol Cancer. 2014 Sep;24(7):1146-57. doi: 10.1097/IGC.0000000000000207.
- Maddocks M, Lewis M, Chauhan A, Manderson C, Hocknell J, Wilcock A. Randomized controlled pilot study of neuromuscular electrical stimulation of the quadriceps in patients with non-small cell lung cancer. J Pain Symptom Manage. 2009 Dec;38(6):950-6. doi: 10.1016/j.jpainsymman.2009.05.011.
- Bennett MI, Johnson MI, Brown SR, Radford H, Brown JM, Searle RD. Feasibility study of Transcutaneous Electrical Nerve Stimulation (TENS) for cancer bone pain. J Pain. 2010 Apr;11(4):351-9. doi: 10.1016/j.jpain.2009.08.002. Epub 2009 Oct 22.
- Robb K, Oxberry SG, Bennett MI, Johnson MI, Simpson KH, Searle RD. A cochrane systematic review of transcutaneous electrical nerve stimulation for cancer pain. J Pain Symptom Manage. 2009 Apr;37(4):746-53. doi: 10.1016/j.jpainsymman.2008.03.022. Epub 2008 Sep 14.
- Yang EJ, Lim JY, Rah UW, Kim YB. Effect of a pelvic floor muscle training program on gynecologic cancer survivors with pelvic floor dysfunction: a randomized controlled trial. Gynecol Oncol. 2012 Jun;125(3):705-11. doi: 10.1016/j.ygyno.2012.03.045. Epub 2012 Apr 1.
- Ryu JS, Kang JY, Park JY, Nam SY, Choi SH, Roh JL, Kim SY, Choi KH. The effect of electrical stimulation therapy on dysphagia following treatment for head and neck cancer. Oral Oncol. 2009 Aug;45(8):665-8. doi: 10.1016/j.oraloncology.2008.10.005. Epub 2008 Dec 17.
- Wang S, Gao L, Wen H, Gao Y, Lv Q, Li H, Wang S, Wang Y, Liu Q, Han J, Wang H, Li Y, Yu N, Wang Q, Cao T, Wang S, Sun H, Wang Z, Sun X, Wang J. Evaluation of pelvic floor muscle function (PFMF) in cervical cancer patients with Querleu-Morrow type C hysterectomy: a multicenter study. Arch Gynecol Obstet. 2022 Feb;305(2):397-406. doi: 10.1007/s00404-021-06290-6. Epub 2021 Oct 28.
- Li XW, Gao L, Wang Q, Lv QB, Xia ZJ, Wen HW, Han JS, Wu YM, Wang SM, Liu Q, Li H, Wang HB, Li Y, Wang SY, Wang ZQ, Sun XL, Wang JL. Long-Term Effect of Early Post-operative Transcutaneous Electrical Stimulation on Voiding Function After Radical Hysterectomy: A Multicenter, Randomized, Controlled Trial. Front Med (Lausanne). 2021 Sep 30;8:677029. doi: 10.3389/fmed.2021.677029. eCollection 2021.
- Sun XL, Wang HB, Wang ZQ, Cao TT, Yang X, Han JS, Wu YF, Reilly KH, Wang JL. Effect of transcutaneous electrical stimulation treatment on lower urinary tract symptoms after class III radical hysterectomy in cervical cancer patients: study protocol for a multicentre, randomized controlled trial. BMC Cancer. 2017 Jun 15;17(1):416. doi: 10.1186/s12885-017-3387-1.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 april 2015
Primaire voltooiing (Verwacht)
1 december 2018
Studie voltooiing (Verwacht)
1 december 2019
Studieregistratiedata
Eerst ingediend
25 juni 2015
Eerst ingediend dat voldeed aan de QC-criteria
7 juli 2015
Eerst geplaatst (Schatting)
8 juli 2015
Updates van studierecords
Laatste update geplaatst (Werkelijk)
14 maart 2018
Laatste update ingediend die voldeed aan QC-criteria
13 maart 2018
Laatst geverifieerd
1 maart 2018
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- D151100001915003
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