Impact of Prostate Surgery for LUTS on Patients' QOL With Emphasis on Sexual- and Ejaculatory Function
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,200
- Locations
- 1
- Primary Endpoint
- Preservation of QOL after surgery for BPH
Study Overview
Brief Summary
Rationale: A variety of surgical techniques have been described for surgical treatment of male LUTS because of BPH, which has different outcomes and may result in adverse events regarding ejaculatory function and erection, resulting in a negative impact on QOL on short- and mid-term follow-ups.
Objective: To compare outcomes of BPH surgery using a conventional versus ejaculation preserving technique on QOL-related aspects with emphasis on ejaculatory and erectile function.
Study design: This study is a prospective longitudinal multi-center trial to compare the ejaculatory and erectile function outcomes between conventional and ejaculation preserving BPH surgical procedures/techniques. Baseline characteristics will be recorded, as well as short and mid-term follow-up.
Study population: The study population comprises patients who will undergo BPH surgery in the participating centers.
Intervention: All patients will undergo BPH surgery (including but not restricted to Monopolar / Bipolar Transurethral resection of the prostate (TURP), photo vaporisation (PVP), Plasmakinetic (PK), Holmium laser enucleation of the prostate (HOLEP) or open prostatectomy (OP)).
Main study parameters/endpoints: Primary endpoint is to compare the baseline to the short-term (3 months) and mid-term (6 months) ejaculation function and QoL outcomes. The secondary endpoint is the short and mid-term erection function and QoL outcomes compared to baseline.
Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: Patients' burden and risk associated with participating in this trial do not differ among surgical procedures or techniques used. In all groups, patients will undergo a BPH surgery and will be followed for six months at 3 visits.
Detailed Description
Benign prostatic hyperplasia (BPH) is a common condition in aging men, which may lead to lower urinary tract symptoms (LUTS) and sexual dysfunction, negatively impacting the patients' quality of life. Despite allowing relief from LUTS, classical medical and surgical treatments for BPH have always been burdened by important consequences on the patients' sexual and ejaculatory function. Over the past three decades, research has focused on the development of new surgical strategies to reduce morbidity and complications of surgical procedures, however, in most cases overlooking the impact on the patients' quality of life aspects.
Despite the well-documented advantages of Laser techniques over transurethral resection of prostate (TURP) and open prostatectomy (OP), they have not been able to overcome postoperative ejaculatory dysfunction (EjD). It is well known that loss of ejaculation after endoscopic surgery was and is still attributed by many to compromising the ejaculatory mechanism, causing retrograde ejaculation. The ejaculatory mechanism has long been misunderstood and misinterpreted. However, recent evidence on ejaculation physiology has demonstrated the importance of the tissues surrounding the verumontanum, rather than the bladder neck, for outward ejaculation . Dynamic transrectal ultrasonography (TRUS) has shown how, just before ejaculation, the verumontanum undergoes a caudal shift, contacting the anterior wall of the urethra, allowing the antegrade progression of semen, which is emitted into the inframontanal urethra and expelled, almost simultaneously, through the external sphincter. No accumulation of semen inside the prostatic urethra, and therefore, generation of a high-pressure area was demonstrated. A fundamental role in this process is played by the musculus ejaculatorious, a longitudinal strain of muscle fibers, which originate from around the ejaculatory ducts and extend caudally in the urethral crest, inserting below the urethral sphincter. Contraction of the musculus ejaculatorious could be responsible not only for the emission of semen from the ejaculatory ducts into the prostatic urethra, but also for the correct movement of the veru montanum during ejaculation. Based on these findings, supramontanal and paracollicular tissue-sparing surgical techniques have been developed. Ejaculation preserving (EP) techniques have been applied to TURP, Photoselective vaporization of the prostate (PVP) and Holmium laser enucleation of the prostate (HOLEP) with encouraging results.
EP technique will be performed as:
During BPH open and endoscopic surgery, all prostatic tissue except adjacent to the verumontanum is removed. Ejaculation preserving endoscopic prostatectomy is a new technique, where all apical prostatic tissue is removed by resecting tissue up to 1 cm above the verumontanum laterally and proximally, to preserve antegrade ejaculation.
Operating physicians will report the type or surgery technique in terms of preservation or not of the ejaculation as: "no", "probably no", "probably yes" or "yes"
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 40 Years to 90 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Has signed informed consent
- •Is aged 40 years or older
- •With or without erectile function and/or antegrade ejaculation
- •No limitation for prostate volume
- •Height 150-250 cm
- •Weight 40-150 kg
- •Age 40-90 years old
- •PSA 0.1-30 ng/ml
- •Creatinine 0.5-4mg/dl
Exclusion Criteria
- •History of BPH surgery
- •History of pelvic radiation
- •History of chronic prostatitis or chronic pelvic pain syndrome
- •History of urethral stricture
- •History of bladder neck contracture
- •Has or has had tumors in the urinary tract
- •Has or has had prostate cancer
- •Has had previous irradiation of the pelvis
- •Has bladder stone
- •Has urinary tract infection (UTI)
- •Has chronic UTI
- •Has neurogenic disorder
- •Has conditions associated with a risk of poor protocol compliance
- •Has participation in other clinical studies with investigational drugs either concurrently or within the last 30 days
Outcomes
Primary Outcomes
Preservation of QOL after surgery for BPH
Time Frame: Baseline to 6 months after surgery
QOL will be assessed before and after by means of validated SF-12 questionnaire
Preservation of voiding function after ejaculation preserving BPH surgery
Time Frame: Baseline to 6 months after surgery
LUTS will be assessed before and after by means of IPSS validated questionnaire
Preservation of ejaculatory function after surgery for BPH
Time Frame: Baseline to 6 months after surgery
Ejaculatory function will be assessed before and after by means of MSHQ-EjD-SF validated questionnaire
Preservation of sexual function after surgery for BPH
Time Frame: Baseline to 6 months after surgery
Sexual function will be assessed before and after by means of IIEF-5 validated questionnaire
Secondary Outcomes
- Comparison objective outcomes of uroflowmetry Qmax parameter (ml/sec) in relation to outcomes in preservation of ejaculation and unpreserved surgery(Baseline to 6 months after surgery)
- Comparison residual urine volumes (Post-voided residual urine, ml) by ultrasound measurement in relation to outcomes in preservation of ejaculation and unpreserved surgery(Baseline to 6 months after surgery)
- Comparison changes in erectile function between conventional and preserving ejaculatory techniques by using IIEF-5 validated questionnarie(Baseline to 6 months after surgery)
- Comparison of post-operative complications among the different disobstructive methods(From the day of the operastion up to 90 days)
Investigators
vahit guzelburc
Assistant Professor of Urology
Istanbul Medipol University Hospital
