Transient Urinary Incontinence After Holmium Laser Enucleation of the Prostate (HoLEP)

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01108367
First received: April 20, 2010
Last updated: May 9, 2011
Last verified: May 2011
  Purpose

In men, urinary incontinence (UI) is relatively uncommon, and usually associated with some forms of prostate surgery. Thus, one of the risks of surgery for benign prostate hyperplasia (BPH) is postoperative UI. The guidelines of the American Urological Association for BPH treatment indicate that UI (2~5%) is relevant complications after transurethral prostatectomy (TURP). Rassweiler et al., based on a review of publications stated that early UI may occur in up to 30-40% of patients after TURP. Rigatti et al. reported that early postoperative urgency UI occurred in 38.6% (TURP) and 44% (holmium laser enucleation of the prostate; HoLEP) of surgically treated patients at 1-month after the surgery. Recently, the follow-up data for patients treated with HoLEP showed that transient stress UI developed in up to 44% after HoLEP. Although this alternative surgical treatment such as HoLEP can be performed safely with minimal complications, patients often face debilitating UI during the postoperative period before any improvement in micturition parameters occurs. Although this symptom ameliorates within a relatively short time, it usually cause significant stress and anxiety to the patient as far as their durations is concerned. In addition to its economic cost, UI is a distressing condition that has major impacts on a patient's quality of life. Social withdrawal, isolation, and depression occur in some patients.

Because this problem is usually temporary, there has been little attempt at addressing the issue. Therefore, there has been no research devoted specifically to transient de novo UI associated with HoLEP.

1. The aim of the present study was following:

  1. to investigate the incidence of transient de novo UI after HoLEP for BPH
  2. determine the predictors of early postoperative transient de novo UI.

Condition
Prostatic Hyperplasia
Incontinence

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Predictor of Transient Urinary Incontinence Following Holmium Laser Enucleation of the Prostate

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Enrollment: 204
Study Start Date: November 2009
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

men who underwent HoLEP for lower urinary tract symptoms (LUTS) with BPH refractory to alpha blocker medication

Criteria

Inclusion Criteria:

  • age older than 50 years
  • presence of moderate or severe LUTS (International Prostate Symptom Score [IPSS] greater than 8)or maximum flow rate of less than 10 mL/s

Exclusion Criteria:

  • previous prostate surgery
  • urethral stricture
  • prostate carcinoma
  • neurogenic bladder disease
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01108367

Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Min Chul Cho, M.D. Seoul National University Hospital
Study Chair: Jae-Seung Paick, M.D.,Ph.D. Seoul National University Hospital
  More Information

Publications:
Responsible Party: Jae-Seung Paick/M.D.,Ph.D., Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01108367     History of Changes
Other Study ID Numbers: HoLEPUI
Study First Received: April 20, 2010
Last Updated: May 9, 2011
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Urinary Incontinence
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014