ClinicalTrials.gg
Status unknownNCT04128280Updated May 12, 2020

Multi-center Clinical Observation of a New Treatment Method Based on the Pathogenesis of Obstructive Prostatitis

An interventional study of TUDP and TUIB in Chronic Prostatitis, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to male participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-05-12.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
35 Years to 80 Years
Sex
Male
01

Study summary

Multi-center clinical observation of a new treatment method based on the pathogenesis of obstructive prostatitis

Read the detailed description
  1. Study purpose: To investigate the therapeutic effect of transurethral dilation of prostate with a columnar balloon on patients with chronic obstructive prostatitis
  2. Study design: A randomized, controlled, multi-center clinical trial
  3. Study subjects: Patients with chronic obstructive prostatitis
  4. Number of subjects: 180
  5. Surgery treatments:

Test group: Patients will receive a surgery: transurethral dilation of prostate with a columnar balloon.

Control group: Patients will receive a surgery: transurethral incision of bladder neck.

02

Conditions studied

  • Chronic Prostatitis

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Keywords

  • Chronic Prostatitis
03

In context

Prostatitis

88 studies on the registry are indexed under Prostatitis; 11 are open to participants now.

This study's planned enrollment of 180 is above the median of 60 across 73 interventional studies indexed under Prostatitis.

Browse Prostatitis studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. older than 35 years old, urinary obstruction is clear;
  2. the total score of chronic prostatitis symptoms index (CPSI) is greater than 14 points, and the severity of symptoms is greater than 9 points;
  3. maximum urine flow rate is less than 15 ml/s;
  4. cystoscopy and pathological confirmed the presence of bladder neck fibrosis, bladder trabeculae formation;
  5. other conservative treatments are ineffective or ineffective, and drug treatment is not effective for more than 6 months;
  6. voluntarily participated in this clinical trial, complied with the requirements of this study and signed the form.

Exclusion criteria

Exclusion Criteria:

  1. urinary tract infection, urinary tumor, history of intestinal inflammatory disease;
  2. neurogenic bladder;
  3. history of pelvic radiation therapy or chemotherapy;
  4. PSA is abnormal;
  5. urethral stricture, history of bladder or prostate surgery;
  6. the investigator determined that it is not suitable for this clinical trial.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Test Group

    Test group: Patients will receive a surgery: transurethral dilation of prostate with a columnar balloon

    Procedure: TUDP

  • Active comparator
    Control Group

    Control group: Patients will receive a surgery: transurethral incision of bladder neck.

    Procedure: TUIB

Interventions

  • ProcedureTUDP

    a surgery: transurethral dilation of prostate with a columnar balloon

  • ProcedureTUIB

    a surgery: transurethral incision of bladder neck

06

What researchers measure

Primary outcomes

  1. The score of CPSI

    measure the chronic prostatitis symptom index (CPSI) by a questionnaire

    Time frame: within 12 months after surgery

07

Study locations

1 of 1 sites recruiting
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
    Hangzhou, Zhejiang 310009, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04128280
Responsible party
Sponsor
First posted
Oct 16, 2019
Start date
Jan 1, 2020
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
May 12, 2020

Study contacts

Shigeng Zhang, Dr.
Contact
zsg710728@zju.edu.cn
+86-571-87783550

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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