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Evaluation of the Effects of Different Prostate Surgeries on Urinary and Sexual Function

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ClinicalTrials.gov Identifier: NCT01810068
Recruitment Status : Completed
First Posted : March 13, 2013
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Ahmed Elshal, Mansoura University

Brief Summary:

The impact of of different surgical treatment modalities of benign prostatic hyperplasia in men on their sexual function is not well studied.

The investigators will investigate prospectively the effect of conventional monopolar transurethral resection of the prostate (TURP), bipolar TURP and Holmium laser enucleation on urinary and sexual functions.


Condition or disease Intervention/treatment Phase
Sexual Functions and Problems in the Adult Procedure: Holmium laser enucleation of the prostate Procedure: Monopolar transurethral resection of the prostate Procedure: Bipolar transurethral resection of the prostate Procedure: Diagnostic cystoscopy Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 262 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Effects of Monopolar Transurethral Resection Versus Bipolar Transurethral Resection and Holmium Laser Enucleation of the Prostate on Urinary and Sexual Function; a Prospective Comparative Study.
Study Start Date : January 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2015

Arm Intervention/treatment
Sham Comparator: Placebo
patients who are undergoing diagnostic cystoscopy
Procedure: Diagnostic cystoscopy
Cysto-urethroscopy

Active Comparator: HOLEP
Holmium laser enucleation of the prostate
Procedure: Holmium laser enucleation of the prostate
Laser assisted enucleation of the prostatic adenoma
Other Name: HOLEP

Active Comparator: monopolar TURP
Monopolar transurethral resection of the prostate
Procedure: Monopolar transurethral resection of the prostate
using the monopolar electrocautery to resect the prostate adenoma
Other Name: TURP

Active Comparator: Bipolar TURP
Bipolar transurethral resection of the prostate
Procedure: Bipolar transurethral resection of the prostate
using the bipolar electrocautery to resect the prostate adenoma
Other Name: TURiS




Primary Outcome Measures :
  1. Change in sexual function [ Time Frame: 12 months postoperative ]
    Sexual function questionnaire (change in the score from baseline)


Secondary Outcome Measures :
  1. Change in urinary function [ Time Frame: six months postoperative ]
    symptoms score (IPSS), urine flow rate (Q-max) and postvoid residual urine (PVR)



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Lower urinary symptoms (LUTS) secondary to bladder outlet obstruction from BPH.
  2. Failed medical treatment of BPH.
  3. International prostate symptom score (IPSS) >9.
  4. Peak urinary flow rate (Qmax) <10 ml/sec.
  5. Patients in retention secondary to BPH.
  6. Total prostate size not less than 30 gm by TRUS (transrectal ultrasound)

    -

Exclusion Criteria:

  1. Patient who have a neurological disorder as neurogenic bladder, cerebrovascular stroke or Parkinson disease.
  2. Non BPH causes of LUTS as cystitis.
  3. Infravesical causes of LUTS other than BPH as urethral stricture.
  4. Presence of active bladder cancer (within the last 2 years).
  5. Known cancer prostate patients on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810068


Locations
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Egypt
Urology and Nephrology Center
Mansoura, Aldakahlia, Egypt, 35516
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Ahmed M Elshal, MD Mansoura University

Publications:
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Responsible Party: Ahmed Elshal, Lecturer of endourology, Mansoura University
ClinicalTrials.gov Identifier: NCT01810068     History of Changes
Other Study ID Numbers: Mans-01-2013
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015
Keywords provided by Ahmed Elshal, Mansoura University:
BPH- Erectile function- Transurethral- Laser