Clinical trial NCT04021901: A Study of Balloon Dilatation for the Treatment of Benign Ureteral Stricture
Official title: A Prospective Multicenter Study of Balloon Dilatation for the Treatment of Benign
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stricture Ureter
Keywords: benign ureteral stricture
balloon dilatation
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Rate of treatment success in follow-up results after 6 months
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Rate of treatment success during the operation
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
References:
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