A Study of Balloon Dilatation for the Treatment of Benign Ureteral Stricture

A Prospective Multicenter Study of Balloon Dilatation for the Treatment of Benign

This study is designed to treat benign ureteral stricture with balloon dilatation through prospective multicenter studies. It aims to indications, procedure standards, and therapeutic effects of balloon dilation, and provide further guidance for endoscopic treatment of benign ureteral stricture.

Study Overview

• Status: Unknown
• Conditions: Stricture Ureter
• Intervention / Treatment: Device: balloon dilatation

Detailed Description

Benign ureteral stricture refers to a urinary tract obstruction caused by a partial or full ureteral lumen that is less normal than normal. It can lead to urinary dilatation, water accumulation, and renal colic in the upper segment of the stenosis. If treat not in time, it will affect renal function and even causes irreversible kidney failure.In recent years, with the development of endoscopic techniques, it provides a cost-effective and less invasive treatment for the treatment of ureteral stricture. In recent years, with the development of endoscopic techniques, it has provided a cost-effective and less invasive treatment for the treatment of ureteral stricture, and has achieved satisfactory results. Therefore, more and more urologists choose to treat ureteral stricture under endoscopy. The techniques of urinary endoscopic treatment of benign ureteral stricture include ureteral balloon dilatation, ureteral holmium laser incision, and ureteral stent implantation. Among them, the ureteral balloon dilatation technique is characterized by the use of a balloon to uniformly force the ureteral wall, tearing the narrow scar tissue, expanding the inner diameter of the ureter, recanalizing the urinary tract, and alleviating hydronephrosis. It have been reported with less complications and simple procedure. However, there's still no consensus on its treatment indication，procedure standards and curative effect. This study is designed to treat benign ureteral stricture with balloon dilatation through prospective multicenter studies. It aims to indications, procedure standards, and therapeutic effects of balloon dilation, and provide further guidance for endoscopic treatment of benign ureteral stricture.

• Study Type: Observational
• Enrollment (Anticipated): 420

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Recruiting
      • Changhai Hospital
      • Contact: Gao Xiaofeng, MD; Phone Number: 0086-13601600968; Email: gxfdoc@hotmail.com
      • Contact: Li Ling, MD; Phone Number: 0086-18019766513; Email: ejdll@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients diagnosed with ureteral stricture or atresia by enhanced CTU, intravenous pyelography or retrograde pyelography, and ureteral stenosis length is ≤ 2cm (single or multiple segments)

Description

Inclusion Criteria:

• • Subject has provided informed consent and indicated a willingness to comply with study treatments

  • Subject is 18-70 yrs of age
  • Subject can be either male or female
  • Subject diagnosed with ureteral stricture or atresia by enhanced CTU, intravenous pyelography or retrograde pyelography;
  • Subject's ureteral stenosis length is ≤ 2cm (single or multiple segments)

Exclusion Criteria:

• • Subject has any congenital ureteral anatomical deformity, abdominal organ compression, oppression caused by malignant tumor metastasis

  • Subject has poor result after endoscopic balloon dilatation treatment
  • Subject has a GFR <25% on the affected side of the kidney
  • Subject has an active urinary tract infection (e.g., cystitis, prostatitis, urethritis, etc.)
  • Subject has been diagnosed with a urethral stricture or bladder neck contracture
  • Subject has been diagnosed with a urinary tract infection related to stone obstruction within two weeks
  • Subject has severe hematuria that might blur the vision of the endoscopy
  • Subject is pregnant or in monthly period
  • Subject has coexistent disease like systemic disease, heart disease, lung disfuction or other diseases that could not tolerate the endoscopic surgery or anesthesia.
  • Subject has unadjusted diabetes or high blood pressure
  • Subject has a disorder of the coagulation cascade system that would put the subject at risk for intraoperative or postoperative bleeding
  • Subject is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (2 weeks)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
F21; balloon diameter F21	Device: balloon dilatation; The balloon catheter (BD U30) was placed through narrow ureter along the guide wire, and the balloon was pressurized to 25 atm until the "bee waist sign" disappeared on the balloon or the narrow section was seen under the endoscope. Dilation, expansion for 10 min, and then through the endoscope to observe the stenosis of the stenosis (stenosis of the stenosis of the visible adipose tissue)
F24; balloon diameter F24	Device: balloon dilatation; The balloon catheter (BD U30) was placed through narrow ureter along the guide wire, and the balloon was pressurized to 25 atm until the "bee waist sign" disappeared on the balloon or the narrow section was seen under the endoscope. Dilation, expansion for 10 min, and then through the endoscope to observe the stenosis of the stenosis (stenosis of the stenosis of the visible adipose tissue)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of treatment success in follow-up results after 6 months	The treatment is effective (satisfying any of the following 3 items, that is, the treatment is considered effective) Treatment failure (not satisfying any of the following 3 items is invalid, that is, treatment failure); Retrograde pyelography normal development;; ECT shows improvement in renal function on the affected side;; CT shows the reduced hydronephrosis.	6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of treatment success during the operation	Effective: the balloon is expanded through the stenosis segment, and the diameter of the ureteral tube is obviously thickened after expansion, and the scar tissue is obviously torn, and the surrounding adipose tissue is visible;; Failure: The guidewire or balloon cannot pass through the stenotic segment of the ureter and cannot expand the stenosis (the scar tissue is not torn).	Intraoperative

Collaborators and Investigators

• Sponsor: Changhai Hospital

Publications and helpful links

General Publications

• Dong H, Peng Y, Li L, Gao X. Prevention strategies for ureteral stricture following ureteroscopic lithotripsy. Asian J Urol. 2018 Apr;5(2):94-100. doi: 10.1016/j.ajur.2017.09.002. Epub 2017 Sep 22.
• Lojanapiwat B, Soonthonpun S, Wudhikarn S. Endoscopic treatment of benign ureteral strictures. Asian J Surg. 2002 Apr;25(2):130-3. doi: 10.1016/S1015-9584(09)60160-3.
• Kramolowsky EV, Tucker RD, Nelson CM. Management of benign ureteral structures: open surgical repair or endoscopic dilation? J Urol. 1989 Feb;141(2):285-6. doi: 10.1016/s0022-5347(17)40742-7.
• Fasihuddin Q, Abel F, Hasan AT, Shimali M. Effectiveness of endoscopic and open surgical management in benign ureteral strictures. J Pak Med Assoc. 2001 Oct;51(10):351-3.
• Brooks JD, Kavoussi LR, Preminger GM, Schuessler WW, Moore RG. Comparison of open and endourologic approaches to the obstructed ureteropelvic junction. Urology. 1995 Dec;46(6):791-5. doi: 10.1016/S0090-4295(99)80345-8.
• Chandhoke PS, Clayman RV, Stone AM, McDougall EM, Buelna T, Hilal N, Chang M, Stegwell MJ. Endopyelotomy and endoureterotomy with the acucise ureteral cutting balloon device: preliminary experience. J Endourol. 1993 Feb;7(1):45-51. doi: 10.1089/end.1993.7.45.
• Bromwich E, Coles S, Atchley J, Fairley I, Brown JL, Keoghane SR. A 4-year review of balloon dilation of ureteral strictures in renal allografts. J Endourol. 2006 Dec;20(12):1060-1. doi: 10.1089/end.2006.20.1060.
• Liu JS, Hrebinko RL. The use of 2 ipsilateral ureteral stents for relief of ureteral obstruction from extrinsic compression. J Urol. 1998 Jan;159(1):179-81. doi: 10.1016/s0022-5347(01)64050-3.
• Ravery V, de la Taille A, Hoffmann P, Moulinier F, Hermieu JF, Delmas V, Boccon-Gibod L. Balloon catheter dilatation in the treatment of ureteral and ureteroenteric stricture. J Endourol. 1998 Aug;12(4):335-40. doi: 10.1089/end.1998.12.335.
• Tyritzis SI, Wiklund NP. Ureteral strictures revisited...trying to see the light at the end of the tunnel: a comprehensive review. J Endourol. 2015 Feb;29(2):124-36. doi: 10.1089/end.2014.0522. Epub 2014 Oct 23.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: July 12, 2019
• First Submitted That Met QC Criteria: July 14, 2019
• First Posted (Actual): July 16, 2019

Study Record Updates

• Last Update Posted (Actual): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 14, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: benign ureteral stricture; balloon dilatation
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic; Dilatation, Pathologic
• Other Study ID Numbers: SHOT-20181112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No