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CompletedNCT01895153Updated Dec 10, 2020

Efficacy Study of Pentosan Polysulfate Sodium,Hydrodistension and Combination Therapy for Bladder Pain Syndrome

An observational study in Bladder Pain Syndrome, Pentosan Polysulfate and Hydrodistension, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2020-12-10.

Sponsored by Samsung Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
91
Sex
All
01

Study summary

The efficacy of pentosan polysulfate sodium, hydrodistension and combination therapy in patients with bladder pain syndrome.

02

Conditions studied

  • Bladder Pain Syndrome
  • Pentosan Polysulfate
  • Hydrodistension

Keywords

  • bladder pain syndrome
  • pentosan polysulfate
  • hydrodistension
03

In context

Cystitis, Interstitial

220 studies on the registry are indexed under Cystitis, Interstitial; 33 are open to participants now.

This study's enrollment of 91 is close to the median of 91 across 57 observational studies indexed under Cystitis, Interstitial.

Browse Cystitis, Interstitial studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Bladder pain syndrome patients have not been treated with hydrodistention.

Inclusion criteria

  1. men and women who were over 18 years old and had symptoms over 6 months.
  2. 4 or more with an pain visual analogue score
  3. 12 or more O'Leary-Sant Intersttial Cystitis questionnaire (IC-Q) symptom and problem score and with a pain score and nocturia score of 2 or more.

Exclusion criteria

Exclusion Criteria:

  1. history of hydrodistention,augumentation cystoplasty due to IC/BPS
  2. pentosan polysulfate sodium (Elmiron) history over 1 month within 6 months.
  3. Women of child-bearing potential who were pregnant or nursing
  4. mean voided volume lesser than 40ml or over than 400ml.
  5. hematuria exceeds 1+ in the urinary dipstick (dipstick) examination.
  6. urinary tract infection during run-in periods.
  7. genitourinary tuberculosis or bladder,urethral and prostate cancer
  8. recurrent urinary tract infection
  9. history of hystrectomy,mid-urethral sling,pelvic organ prolapse repair,vaginal delivery or Cesarean section,prostate opreation or treatment etc within 6months.
  10. neurologic disease history of cerebral infaction,multiple sclerosis or parkinsonism etc.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
91 participants (actual)
Patient registry
No

Groups and cohorts

  • pentosan polysulfate cohort

    pentosan polysulfate monotherapy

  • hydrodistension(HD) cohort

    hydrodistension(HD) monotherapy

  • combination cohort

    combination therapy of pentosan polysulfate and hydrodistension.

06

What researchers measure

Primary outcomes

  1. the change of IC-Q symptom index(ICSI)score from baseline to 6 months after each treatment

    Time frame: 6months

Secondary outcomes

  1. The change of voiding dairy parameters(mean number of micturition,Urgency etc) after each treatment.

    Time frame: 1,2,4 and 6months after each treatment .

  2. The change of O'Leary-Sant Intersttial Cystitis questionnaire (IC-Q)score after each treatment

    Time frame: 1,2,4 and 6months after each treatment .

  3. The change of Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF)

    Time frame: 1,2,4 and 6months after each treatment .

  4. The change of Global Response Assessment(GRA) score

    Time frame: 1,2,4 and 6months after each treatment .

  5. The change of EQ-5D Health Questionnaire score

    Time frame: 1,2,4 and 6months after each treatment .

  6. The change of Brief Pain Inventory-short form(BPI-sf) score

    Time frame: 1 and 6months after each treatment.

  7. The estimation of safty and Complications for each treatment

    Time frame: 1,2,4 and 6months after each treatment .

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, 135-710, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01895153
Lead sponsor
Samsung Medical Center
Responsible party
KYU-SUNG LEE (professor,MD,PhD, Samsung Medical Center) — Principal investigator
First posted
Jul 10, 2013
Start date
Apr 2012
Primary completion
May 2020
Completion
May 2020
Last update
Dec 10, 2020

Study contacts

Kyu-Sung Lee, MD,Ph.D
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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