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Lower Urinary Tract SymptomsNCT02492542

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

A study testing PHENIX USB 8. in people with Lower Urinary Tract Symptoms, run by Wang Jianliu.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years, women only
Conditions the study is for
Lower Urinary Tract Symptoms
What is being tested?
PHENIX USB 8.
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
208 participants
Where
No sites listed yet
Study dates
Apr 2015to Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

About this study

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.

Read the detailed 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.

Being tested
PHENIX USB 8.
Keywords
electrical stimulation, urinary incontinence
Medical subject headings
Lower Urinary Tract Symptoms, Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PHENIX USB 8.Device

    Also called Electric Stimulation Treatment

    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.

Study groups in NCT02492542
Study groupRoleWhat they receive
Electric Stimulation TreatmentExperimentalPatients in the intervention group were treated with electric stimulation based on the routine clinical nursing.
Receives: Device: PHENIX USB 8.
control groupNo interventionpatients in this group only received routine clinical nursing without electric stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Urination function recovery rate

    Measured: From 14 days to 24 months after operation

Secondary outcomes (4)

  1. Number of participants with recovery of defecation function and urinary function after III hysterectomy

    Measured: From 14 days to 24 months after operation

  2. Quality of life Questionnaire

    Measured: From 14 days to 24 months after operation

  3. 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

    Measured: From 14 days to 24 months after operation

  4. 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)

    Measured: From 14 days to 24 months after operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
208 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02492542
Sponsor's protocol ID
D151100001915003
Status last verified
Mar 2018
First submitted
25 Jun 2015
Last updated
14 Mar 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21277788

  • 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.

    PubMed 9299255

  • 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.

    PubMed 16445968

  • 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.

    PubMed 16445658

  • 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.

    PubMed 12375757

  • 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.

    PubMed 16516431

  • 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.

    PubMed 15512265

  • 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.

    PubMed 19374292

  • 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.

    PubMed 20571765

  • 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.

    PubMed 1894168

  • 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.

    PubMed 25033255

  • 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.

    PubMed 19748761

  • 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.

    PubMed 19853518

  • 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.

    PubMed 18790600

  • 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.

    PubMed 22472463

Questions about this trial

What is this clinical trial studying?

A study testing PHENIX USB 8. in people with Lower Urinary Tract Symptoms, run by Wang Jianliu.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urination function recovery rate (time frame: From 14 days to 24 months after operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02492542, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.

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