Sexual Functions and Problems in the AdultPhase 4NCT01810068
Evaluation of the Effects of Different Prostate Surgeries on Urinary and Sexual Function
A Phase 4 study testing Holmium laser enucleation of the prostate, Monopolar transurethral resection of the prostate and Bipolar transurethral resection of the prostate in people with Sexual Functions and Problems in the Adult, run by Mansoura University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Sexual Functions and Problems in the Adult
- What is being tested?
- Holmium laser enucleation of the prostate, Monopolar transurethral resection of the prostate and Bipolar transurethral resection of the prostate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 262 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2013to Apr 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- -
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the detailed description
Benign prostatic hyperplasia (BPH), one of the most common diseases of aging men, can be associated with bothersome lower urinary tract symptoms (LUTS) that affect quality of life. The prevalence of histopathologic BPH is age dependent, with initial development usually after 40 years of age. Similar to that of histologic evidence, the prevalence of bothersome symptoms also increases with age. Approximately half of all men who have a histologic diagnosis have moderate to severe LUTS.
The other common disorder associated with BPH is sexual dysfunction based purely on age. Sexual dysfunction encompasses not only erectile dysfunction (ED), but also ejaculation abnormalities, difficulty in reaching orgasm, decreased libido and overall dissatisfaction. Many studies suggest that the presence of LUTS is a risk factor for sexual dysfunction. Increasing life expectancy has been associated with improvements in the health and quality of life of the elderly, and many studies examined the sexuality of these groups of subjects and reported that their interest in sex persist.
By reviewing the literature, the effect of different modalities for treating BPH, including medical, open surgical, endourological procedures, on urinary function has been extensively discussed and to a less extent on sexual function. A significant problem which arises when discussing the sexual function with patients and partners, and when reviewing the literature, is to know which aspect of male sexual function is being referred to.
Transurethral resection of the prostate (TURP) is still considered the gold standard in treating BPH. However, most authors accept that there will be some impairment of sexual function secondary to this procedure. The exact magnitude of this problem has been difficult to assess by reviewing the published literature. Most of the large series reported ED rates of 10 to 15%. (11\&12) The etiology of ED secondary to TURP is poorly understood. Most likely it is secondary to electrical trauma to the cavernous nerves close to the prostate apex at 5 and 7 o'clock positions. Furthermore, thrombosis of the cavernosal arteries may result from mechanical trauma or from thermal damage.
Post TURP ejaculatory dysfunction was reported and documented to be in the form of retrograde ejaculation in between 25-99 %. The mechanism for that was destruction of the bladder neck mechanism which is responsible for sympathetic mediated occlusion of the bladder neck during ejaculation ending in forward expulsion of the ejaculate.
Since introduction of TURP as an effective tool for treatment of BPH, many endo-urologic techniques were tried to overcome the limitations and drawbacks of this gold standard procedure mainly caused by perioperative bleeding requiring transfusion or re-intervention, irrigation fluid absorption (TUR syndrome) and need for hospital stay.
Currently holmium laser enucleation of the prostate (HoLEP) seems to be an attractive alternative to standard TURP. The efficacy and safety of HoLEP have been demonstrated even in cases of large prostates that otherwise would usually require open prostatectomy. In several comparative randomized studies, HoLEP was found to be superior to TURP in term of catheter time, hospital stay, weight of removed tissue, blood loss but with longer operative time.
However, its impact on male sexual function has not been well established. The successful outcome of relief of LUTs is postulated to favor improving the overall sexual function. However, other factors including laser heating effect, is hypothesized to contribute to postoperative erectile dysfunction.
The safety of bipolar TURP is enhanced by the use of normal saline eliminating the incidence of the metabolite toxicities and dilutional hyponatremia and the physics of electrical current return theoretically reduce the thermal tissue damage at the site of surgery or at a distant site by faulty patient grounding ( patient return electrode pad ). Urologists have observed better intra-operative visibility during bipolar resection, which may also enhance resident education. The deep coagulation effect of bipolar resection is thought to contribute in the postoperative sexual dysfunction. However, sexual function after bipolar TURP is still not well established in the literature.
To the best of the investigators' knowledge there is no any prospective study in the literature comparing these three widely available procedures monopolar TURP, bipolar TURP and HoLEP in term of their urinary, erectile and ejaculatory outcome.
- Being tested
- Holmium laser enucleation of the prostate, Monopolar transurethral resection of the prostate, Bipolar transurethral resection of the prostate, Diagnostic cystoscopy
- Keywords
- BPH- Erectile function- Transurethral- Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holmium laser enucleation of the prostateProcedure or surgery
Also called HOLEP
Laser assisted enucleation of the prostatic adenoma
Monopolar transurethral resection of the prostateProcedure or surgery
Also called TURP
using the monopolar electrocautery to resect the prostate adenoma
Bipolar transurethral resection of the prostateProcedure or surgery
Also called TURiS
using the bipolar electrocautery to resect the prostate adenoma
Diagnostic cystoscopyProcedure or surgery
Cysto-urethroscopy
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Sham comparator | patients who are undergoing diagnostic cystoscopy Receives: Procedure: Diagnostic cystoscopy |
| HOLEP | Active comparator | Holmium laser enucleation of the prostate Receives: Procedure: Holmium laser enucleation of the prostate |
| monopolar TURP | Active comparator | Monopolar transurethral resection of the prostate Receives: Procedure: Monopolar transurethral resection of the prostate |
| Bipolar TURP | Active comparator | Bipolar transurethral resection of the prostate Receives: Procedure: Bipolar transurethral resection of the prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sexual function
Sexual function questionnaire (change in the score from baseline)
Measured: 12 months postoperative
Secondary outcomes (1)
Change in urinary function
symptoms score (IPSS), urine flow rate (Q-max) and postvoid residual urine (PVR)
Measured: six months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexual Functions and Problems in the AdultStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elshal, Mansoura University
- Investigators
- Ahmed M Elshal, MD, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810068
- Sponsor's protocol ID
- Mans-01-2013
- Status last verified
- May 2015
- First submitted
- 10 Mar 2013
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23107401
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01810068
- Acronym / sponsor ID
- Mans-01-2013
- Keywords
- BPH- Erectile function- Transurethral- Laser
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 13 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Benign prostatic hyperplasia (BPH), one of the most common diseases of aging men, can be associated with bothersome lower urinary tract symptoms (LUTS) that affect quality of life. The prevalence of histopathologic BPH is age dependent, with initial development usually after 40 years of age. Similar to that of histologic evidence, the prevalence of bothersome symptoms also increases with age. Approximately half of all men who have a histologic diagnosis have moderate to severe LUTS.
The other common disorder associated with BPH is sexual dysfunction based purely on age. Sexual dysfunction encompasses not only erectile dysfunction (ED), but also ejaculation abnormalities, difficulty in reaching orgasm, decreased libido and overall dissatisfaction. Many studies suggest that the presence of LUTS is a risk factor for sexual dysfunction. Increasing life expectancy has been associated with improvements in the health and quality of life of the elderly, and many studies examined the sexuality of these groups of subjects and reported that their interest in sex persist.
By reviewing the literature, the effect of different modalities for treating BPH, including medical, open surgical, endourological procedures, on urinary function has been extensively discussed and to a less extent on sexual function. A significant problem which arises when discussing the sexual function with patients and partners, and when reviewing the literature, is to know which aspect of male sexual function is being referred to.
Transurethral resection of the prostate (TURP) is still considered the gold standard in treating BPH. However, most authors accept that there will be some impairment of sexual function secondary to this procedure. The exact magnitude of this problem has been difficult to assess by reviewing the published literature. Most of the large series reported ED rates of 10 to 15%. (11\&12) The etiology of ED secondary to TURP is poorly understood. Most likely it is secondary to electrical trauma to the cavernous nerves close to the prostate apex at 5 and 7 o'clock positions. Furthermore, thrombosis of the cavernosal arteries may result from mechanical trauma or from thermal damage.
Post TURP ejaculatory dysfunction was reported and documented to be in the form of retrograde ejaculation in between 25-99 %. The mechanism for that was destruction of the bladder neck mechanism which is responsible for sympathetic mediated occlusion of the bladder neck during ejaculation ending in forward expulsion of the ejaculate.
Since introduction of TURP as an effective tool for treatment of BPH, many endo-urologic techniques were tried to overcome the limitations and drawbacks of this gold standard procedure mainly caused by perioperative bleeding requiring transfusion or re-intervention, irrigation fluid absorption (TUR syndrome) and need for hospital stay.
Currently holmium laser enucleation of the prostate (HoLEP) seems to be an attractive alternative to standard TURP. The efficacy and safety of HoLEP have been demonstrated even in cases of large prostates that otherwise would usually require open prostatectomy. In several comparative randomized studies, HoLEP was found to be superior to TURP in term of catheter time, hospital stay, weight of removed tissue, blood loss but with longer operative time.
However, its impact on male sexual function has not been well established. The successful outcome of relief of LUTs is postulated to favor improving the overall sexual function. However, other factors including laser heating effect, is hypothesized to contribute to postoperative erectile dysfunction.
The safety of bipolar TURP is enhanced by the use of normal saline eliminating the incidence of the metabolite toxicities and dilutional hyponatremia and the physics of electrical current return theoretically reduce the thermal tissue damage at the site of surgery or at a distant site by faulty patient grounding ( patient return electrode pad ). Urologists have observed better intra-operative visibility during bipolar resection, which may also enhance resident education. The deep coagulation effect of bipolar resection is thought to contribute in the postoperative sexual dysfunction. However, sexual function after bipolar TURP is still not well established in the literature.
To the best of the investigators' knowledge there is no any prospective study in the literature comparing these three widely available procedures monopolar TURP, bipolar TURP and HoLEP in term of their urinary, erectile and ejaculatory outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Sham comparator | Procedure: Diagnostic cystoscopypatients who are undergoing diagnostic cystoscopy |
| HOLEP | Active comparator | Procedure: Holmium laser enucleation of the prostateHolmium laser enucleation of the prostate |
| monopolar TURP | Active comparator | Procedure: Monopolar transurethral resection of the prostateMonopolar transurethral resection of the prostate |
| Bipolar TURP | Active comparator | Procedure: Bipolar transurethral resection of the prostateBipolar transurethral resection of the prostate |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Holmium laser enucleation of the prostateAlso: HOLEPLaser assisted enucleation of the prostatic adenoma | Procedure or surgery | HOLEP |
| Monopolar transurethral resection of the prostateAlso: TURPusing the monopolar electrocautery to resect the prostate adenoma | Procedure or surgery | monopolar TURP |
| Bipolar transurethral resection of the prostateAlso: TURiSusing the bipolar electrocautery to resect the prostate adenoma | Procedure or surgery | Bipolar TURP |
| Diagnostic cystoscopyCysto-urethroscopy | Procedure or surgery | Placebo |
Primary outcome
Change in sexual function
Time frame: 12 months postoperative
Sexual function questionnaire (change in the score from baseline)
1 secondary outcome
Change in urinary function
Time frame: six months postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
- Background: PubMed 23107401Elshal 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed M Elshal, MD principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Holmium laser enucleation of the prostate, Monopolar transurethral resection of the prostate and Bipolar transurethral resection of the prostate in people with Sexual Functions and Problems in the Adult, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sexual function (time frame: 12 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01810068, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015.