NCT01810068

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
262

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

May 12, 2015

Status Verified

May 1, 2015

Enrollment Period

1.2 years

First QC Date

March 10, 2013

Last Update Submit

May 8, 2015

Conditions

Sexual Functions and Problems in the Adult

Keywords

BPH- Erectile function- Transurethral- Laser

Outcome Measures

Primary Outcomes (1)

  • Change in sexual function

    Sexual function questionnaire (change in the score from baseline)

    12 months postoperative

Secondary Outcomes (1)

  • Change in urinary function

    six months postoperative

Study Arms (4)

Placebo

SHAM COMPARATOR

patients who are undergoing diagnostic cystoscopy

Procedure: Diagnostic cystoscopy

HOLEP

ACTIVE COMPARATOR

Holmium laser enucleation of the prostate

Procedure: Holmium laser enucleation of the prostate

monopolar TURP

ACTIVE COMPARATOR

Monopolar transurethral resection of the prostate

Procedure: Monopolar transurethral resection of the prostate

Bipolar TURP

ACTIVE COMPARATOR

Bipolar transurethral resection of the prostate

Procedure: Bipolar transurethral resection of the prostate

Interventions

Holmium laser enucleation of the prostatePROCEDURE

Laser assisted enucleation of the prostatic adenoma

Also known as: HOLEP
HOLEP
Monopolar transurethral resection of the prostatePROCEDURE

using the monopolar electrocautery to resect the prostate adenoma

Also known as: TURP
monopolar TURP
Bipolar transurethral resection of the prostatePROCEDURE

using the bipolar electrocautery to resect the prostate adenoma

Also known as: TURiS
Bipolar TURP
Diagnostic cystoscopyPROCEDURE

Cysto-urethroscopy

Placebo

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, Aldakahlia, 35516, Egypt

Location

Related Publications (1)

  • Elshal AM, Elmansy HM, Elkoushy MA, Elhilali MM. Male sexual function outcome after three laser prostate surgical techniques: a single center perspective. Urology. 2012 Nov;80(5):1098-104. doi: 10.1016/j.urology.2012.08.001.

    PMID: 23107401BACKGROUND

MeSH Terms

Interventions

Transurethral Resection of Prostate

Intervention Hierarchy (Ancestors)

ProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ahmed M Elshal, MD

    Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of endourology

Study Record Dates

First Submitted

March 10, 2013

First Posted

March 13, 2013

Study Start

January 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2015

Last Updated

May 12, 2015

Record last verified: 2015-05

Locations

EG(1)