Effect of Pelvic Floor Stimulation on the Pelvic Floor Function in Cervical Cancer Patients With Type III Hysterectomy

Lower Urinary Tract Symptoms Clinical Trial

Official title:

Effect of Pelvic Floor Stimulation on the Pelvic Floor Function in Cervical Cancer Patients With Type III Hysterectomy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02492542
• Other study ID #: D151100001915003
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 25, 2015
• Last updated: March 13, 2018
• Start date: April 2015
• Est. completion date: December 2019

Study information

• Verified date: March 2018
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 208
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed as cervical squamous cell carcinoma on ?a2, Ib1 or ?a1 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.

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Uterine Cervical Neoplasms

Intervention

Device:
• PHENIX USB 8.
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.

Locations

Country	Name	City	State
n/a

Sponsors (10)

Lead Sponsor	Collaborator
Wang Jianliu	Beijing Cancer Hospital, Beijing Chao Yang Hospital, Beijing Hospital, Beijing Obstetrics and Gynecology Hospital, Chinese Academy of Medical Sciences, Chinese PLA General Hospital, Peking University, Peking University First Hospital, Peking University Third Hospital

References & Publications (16)

Axelsen SM, Petersen LK. Urogynaecological dysfunction after radical hysterectomy. Eur J Surg Oncol. 2006 May;32(4):445-9. Epub 2006 Mar 3. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Jackson KS, Naik R. Pelvic floor dysfunction and radical hysterectomy. Int J Gynecol Cancer. 2006 Jan-Feb;16(1):354-63. Review. — View Citation

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: — View Citation

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. — View Citation

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: 10.1 — View Citation

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):2 — View Citation

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 — View Citation

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 200 — View Citation

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. — View Citation

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. — View Citation

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 2 — View Citation

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. Review. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urination function recovery rate		From 14 days to 24 months after operation
Secondary	Number of participants with recovery of defecation function and urinary function after III hysterectomy		From 14 days to 24 months after operation
Secondary	Quality of life Questionnaire		From 14 days to 24 months after operation
Secondary	Overall Survival	The overall survival (OS) in cervical cancer patients after 3 years' III hysterectomy after comparison of pelvic floor rehabilitation therapy and control group	From 14 days to 24 months after operation
Secondary	Disease-free survival	Comparison of pelvic floor rehabilitation treatment group and control group of cervical cancer patients with type III hysterectomy 3 years disease-free survival (DFS)	From 14 days to 24 months after operation

External Links

•   Early Recovery of Urinary Continence After Radical Prostatectomy Using Early Pelvic Floor Electrical Stimulation and Biofeedback Associated Treatment