Clinical Trial Using Bipolar Technology for Transurethral Resection of Bladder Tumor
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01581723 |
Recruitment Status : Unknown
Verified February 2015 by Eddie SY Chan, MD, Chinese University of Hong Kong.
Recruitment status was: Recruiting
First Posted : April 20, 2012
Last Update Posted : February 4, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Urinary Bladder Tumor | Device: Monopolar diathermy Device: Bipolar diathermy | Phase 3 |
Transurethral resection (TUR) of bladder tumor is one of commonest procedures in urology practice. It is the surgery of choice for staging and treating non-muscle invasive bladder cancer. Short lengths of hospital stay, simple and safe are the main advantages of the surgery. Conventional TUR is performed with monopolar diathermy, which commonly elicits obturator reflexes in lateral-located tumor. However, it is not without complication. Bleeding and bladder perforation with or without obturator reflex are the most significant complications after TUR of bladder tumor. The charring effect of monopolar is also a concern as the diagnosis of muscle invasion by tumor is determined by the integrity of tumor base biopsy. Mariappan et al. reported that as high as 33% of the specimen had no detrusor muscle present for assessment. The absent of muscle not only affect the staging procedure but also associated with higher cancer recurrence rate.
Bipolar resection has been widely used in transurethral resection of prostate (TURP). As compared with the traditional monopolar technology, the electric current passes through the instrument sheath. The advantage of bipolar technology includes less obturator reflex, good hemostasis and early recovery. Study has showed that the cautery artifact is more severe on monopolar resection as compared with bipolar in prostate tissues. Due to the clean and precise cutting, there will be less charring on the specimen and thermal injury to peripheral tissues. Applying to bladder tumor resection, this will improve the staging accuracy with better determination of the depth of invasion. Furthermore, with the use of saline instead of glycine as irrigation fluid, risk of TUR syndrome is minimized. There is no randomized trial on the benefit of using bipolar instrument on TUR bladder cancer. In this study, investigator will investigate the role of bipolar technology in TUR bladder cancer as compared with traditional monopolar resection.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Using Biploar Technology for Transurethral Resection of Bladder Tumor - a Randomized Controlled Trial |
Study Start Date : | May 2012 |
Estimated Primary Completion Date : | June 2015 |
Estimated Study Completion Date : | September 2015 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Monopolar TUR
Monopolar diathermy is used to perform tranurethral resection of bladder tumor
|
Device: Monopolar diathermy
monopolar diathermy
Other Names:
|
Experimental: Biploar TUR
Bipolar diathermy is used to perform transurethral resection of bladder tumor
|
Device: Bipolar diathermy
bipolar diathermy
Other Names:
|
- Muscle sampling rate [ Time Frame: An expected average of 7 days post operation ]To assess the charring effect to the integrity of the tumor base biopsy
- Incidence of TUR syndrome [ Time Frame: Intra-operation and up to 7 days post operation ]
- Recurrence rate of bladder cancer [ Time Frame: 3 months and 6 months after surgery ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult male or female patients (age ≥ 18)
- Patients who have diagnosed with bladder cancer (either primary or recurrent) by cystoscopy
Exclusion Criteria:
- Patients who are scheduled for second TUR within 6 weeks after the previous TUR

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01581723
Contact: Eddie SY Chan, MD | +852 2632 2625 | eddie@surgery.cuhk.edu.hk | |
Contact: Cleo NY Lam, BSc | +852 2632 1663 | nylam@surgery.cuhk.edu.hk |
Hong Kong | |
Prince of Wales Hospital | Recruiting |
Shatin, Hong Kong | |
Principal Investigator: Eddie SY Chan, MD | |
Sub-Investigator: Chi Fai Ng, MD | |
Sub-Investigator: Simon SM Hou, MBBS | |
North District Hospital | Not yet recruiting |
Sheung Shui, Hong Kong | |
Sub-Investigator: Ho Yuen Cheung, MBChB |
Principal Investigator: | Eddie SY Chan, MD | Chinese University of Hong Kong |
Responsible Party: | Eddie SY Chan, MD, Dr., Chinese University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT01581723 |
Other Study ID Numbers: |
CUHK_TURB_2012 |
First Posted: | April 20, 2012 Key Record Dates |
Last Update Posted: | February 4, 2015 |
Last Verified: | February 2015 |
urinary bladder tumor monopolar TURBT bipolar TURBT |
Urinary Bladder Neoplasms Neoplasms Urologic Neoplasms Urogenital Neoplasms |
Neoplasms by Site Urinary Bladder Diseases Urologic Diseases |