Benign Prostatic HyperplasiaPARTURPNCT05574244
Comparison of Functional Outcomes of Ejaculation-preserving Partial Trans Urethral Resection of the Prostate With Complete Trans Urethral Resection of the Prostate for Benign Prostatic Obstruction
A study testing Partial surgery preserving the prostatic apex and Conventional endoscopic prostatic surgery in people with Benign Prostatic Hyperplasia, run by University Hospital, Bordeaux at 17 sites in France.
Trial summary
It has been demonstrated that sexual activity was common in the majority of men over 50 years old and was an important component of overall quality of life (QoL). Ejaculatory dysfunction (EjD) is the most common side effect of surgical treatment of benign prostatic obstruction (BPO). Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Partial surgery preserving the prostatic apex and Conventional endoscopic prostatic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 17 sitesFrance
- Study dates
- 29 Sep 2022to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man over 40 years old
- Indication of surgical management for BPH
- Prostate volume ≥30 cc and ≤150 cc as evaluated by ultrasonography ( or an MRI if available)
- IPSS score ≥12
- Qmax ≤15 ml/s
- Affiliated to French national social security system
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- wish and be able to comply with planned visits
- Able to express his consent
- Signed informed consent form
Who cannot join
- Unwillingness to accept the treatment
- No pre-operative ejaculation or sexuality
- Neurological pathology responsible for micturition disorders
- History of prostatic surgery
- Stenosis of the urethra symptomatic
- History of prostate cancer
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- History of radiotherapy or pelvic surgery
- Patient refusing the principle of partial surgery
- Life expectancy <3 years
- Inability to understand the informed consent document, to give consent voluntarily or to complete the study tasks.
- Participation in another clinical study involving an investigational product within 1 month before study entry.
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
France17 sites, 13 recruiting
- Recruiting
CH Pays d'Aix
Aix-en-Provence
FOURMARIER Marc, Dr
- Recruiting
CHU Angers
Angers
LEBDAI Souhil, Dr
- Recruiting
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, 33000
Grégoire ROBERT, 05.57.82.06.87, gregoire.robert@chu-bordeaux.fr
Méric BEN BOUJEMA, 05.57.82.06.87, meric.ben-boujema@chu-bordeaux.fr
- Withdrawn
CHU Mondor
Créteil
- Withdrawn
Hôpital Claude Huriez
Lille
- Recruiting
CHU de Limoges
Limoges
DESCAZEAUD Aurélien, Pr
- Recruiting
Hôpital Nord Marseille
Marseille
BABOUDJIAN Michael, Dr
- Recruiting
Polyclinique Saint George
Nice
ROUSCOFF Yohan, Dr, yohann.ouscoff@clinique-saint-george.com
- Recruiting
Hôpital cochin
Paris
BARY DELONGCHAMPS Nicolas, Pr, nicolas.barry-delongchamps@aphp.fr
- Recruiting
Hôpital Prive Francheville
Périgueux
Mallet Richard, Dr
- Recruiting
Hôpital Lyon Sud HCl Bât.3C Centre Hospitalier Lyon Sud
Pierre-Bénite
Ruffion Alain, Pr, alain.ruffion@chu-lyon.fr
- Recruiting
Hôpital Privé des Côtes D'Armor
Plérin
DELLA NEGRA Emmanuel, Dr
- Recruiting
CHU de Reims- Hôpital Robert Debré
Rennes
TAHA Fayek
- Recruiting
CHU de Rennes
Rennes
Romain MATHIEU, Dr, romain.mathieu@chu-rennes.fr
- Withdrawn
Clinique Pasteur
Toulouse
- Withdrawn
CHRU Hôpitaux de tours
Tours
- Recruiting
Hopital Privé de Versailles, Clinique des Franciscaines
Versailles
Benchikh Amine, Dr
About this study
It has been demonstrated that sexual activity was common in the majority of men over 50 years old and was an important component of overall quality of life (QoL). Ejaculatory dysfunction (EjD) is the most common side effect of surgical treatment of benign prostatic obstruction (BPO). It has been considered for decades to be an inevitable consequence of restoring micturition comfort. EjD can have a substantial deleterious effect on the QoL of men with previously maintained regular sexual activity, inducing decreased orgasmic intensity and increased levels of anxiety and depression. A better understanding of the physiology of ejaculation has enabled the emergence of modified surgical techniques that aim to preserve antegrade ejaculation. Our hypothesis is that conservation of ejaculation can be achieved by modified surgical procedures without compromising functional outcomes.
Read the detailed description
The aim of this study is To compare the efficacy of partial trans urethral resection of the prostate versus conventional resection of the prostate in improvement of lower urinary tract symptoms related to benign prostatic hyperplasia at 6 months. The secondary objectives are to compare the impacts of partial prostatic endoscopic surgery versus conventional endoscopic surgery on ejaculatory function, lower urinary tract symptoms, Global sexual life, Urinary flow, complication related to the surgery and the rates of re-treatment.
Investigators use a non-inferiority comparative single blinded (patient) multicenter randomized clinical trial in two parallel groups (Conventional endoscopic prostatic surgery Vs Partial surgery preserving the prostatic apex.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Partial surgery preserving the prostatic apex, Conventional endoscopic prostatic surgery
- Keywords
- Lower Urinary Tract Symptoms, Transurethral resection of prostate, Partial Transurethral resection of prostate, quality of life, Ejaculation
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial surgery preserving the prostatic apexProcedure or surgery
Partial Endoscopic resection of prostate to conserve apex
Conventional endoscopic prostatic surgeryProcedure or surgery
Endoscopic resection of prostate.
| Study group | Role | What they receive |
|---|---|---|
| Conventional endoscopic prostatic surgery | Experimental | Endoscopic resection of prostate. Receives: Procedure: Conventional endoscopic prostatic surgery |
| Partial surgery preserving the prostatic apex | Experimental | Patients randomised to the partial endoscopic resection group will undergo surgical treatment that preserves the apex area of the prostate (tissue located 1 cm around the veru montanum). Receives: Procedure: Partial surgery preserving the prostatic apex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of IPSS (International Prostatic Symptom Score) score at 6 months
the mean IPSS score measured at 6 months, to compare the efficacy of partial endoscopic resection versus complete endoscopic resection in improvement of lower urinary tract symptoms related to BPH. IPSS scores are categorised as 'asymptomatic' (0 points), 'mildly symptomatic' (1-7 points), 'moderately symptomatic' (8-19 points), and 'severely symptomatic' (20-35 points).
Measured: 6 months after surgery
Secondary outcomes (8)
Evaluation of ejaculation and global sexual life
MSHQ ejd= Male Sexual Health Questionnaire for Ejaculatory Dysfonction Scale score : [1-20] : a higher score mean that the subject have a ejaculatory dysfunction and sexual troubles
Measured: 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Evaluation of lower urinary tract symptoms
Urinary Symptom Profile (USP) :
- 1a+1b+1C [0-9]. A higher score mean that the subject have urinary leakage
- 2+3+4+4bis+5+6+7 [0-21]. A higher score mean that the subject have voiding urgency
- 8+9+10 [0-9]. A higher score mean that the subject have voiding problem
Measured: 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Evaluation of complication rates
Complications based on Clavien Dindo classification
Measured: 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Evaluation of ejaculation and global sexual life
IIEF-15 (including orgasmic function: questions 9 and 10), auto-questionnaire (superiority test)
Measured: 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Evaluation of ejaculation and global sexual life
DAN PPS-SEX= Danish Prostatic Symptom Score -Sexual Questions 1A And B are question about erectyl function Questions 2A, 2B, 3A and 3B are questions about ejaculatory function Questions 4A is a question about global sexual quality of life
Measured: 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Evaluation of lower urinary tract symptoms
IPSS = International Prostate Score Symptom Scale score [0-35]. The higher score mean that the subject have important lower urinary tract symptoms.
Measured: 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Evaluation of lower urinary tract symptoms
Qmax (non-inferiority test) not performed at 1 month
Measured: 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Evaluation of complication rates
Re-intervention rate
Measured: 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start29 Sep 2022
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non inferiority Comparative single-blinded (patient) multicentre randomised clinical trial in two parallel groups: * Group 1: Conventional endoscopic prostatic surgery * Group 2: Partial surgery preserving the prostatic apex
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574244
- Sponsor's protocol ID
- CHUBX 2019/57
- Acronym
- PARTURP
- Status last verified
- Jun 2025
- First submitted
- 13 Sep 2022
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Functional Outcomes of Ejaculation-preserving Partial Trans Urethral Resection of the Prostate With Complete Trans Urethral Resection of the Prostate for Benign Prostatic Obstruction
- ClinicalTrials.gov ID
- NCT05574244
- Acronym / sponsor ID
- PARTURP / CHUBX 2019/57
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Lower Urinary Tract Symptoms, Transurethral resection of prostate, Partial Transurethral resection of prostate, quality of life, Ejaculation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 10 Oct 2022 (actual)
- 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.
It has been demonstrated that sexual activity was common in the majority of men over 50 years old and was an important component of overall quality of life (QoL). Ejaculatory dysfunction (EjD) is the most common side effect of surgical treatment of benign prostatic obstruction (BPO). It has been considered for decades to be an inevitable consequence of restoring micturition comfort. EjD can have a substantial deleterious effect on the QoL of men with previously maintained regular sexual activity, inducing decreased orgasmic intensity and increased levels of anxiety and depression. A better understanding of the physiology of ejaculation has enabled the emergence of modified surgical techniques that aim to preserve antegrade ejaculation. Our hypothesis is that conservation of ejaculation can be achieved by modified surgical procedures without compromising functional outcomes.
Detailed description
The aim of this study is To compare the efficacy of partial trans urethral resection of the prostate versus conventional resection of the prostate in improvement of lower urinary tract symptoms related to benign prostatic hyperplasia at 6 months. The secondary objectives are to compare the impacts of partial prostatic endoscopic surgery versus conventional endoscopic surgery on ejaculatory function, lower urinary tract symptoms, Global sexual life, Urinary flow, complication related to the surgery and the rates of re-treatment.
Investigators use a non-inferiority comparative single blinded (patient) multicenter randomized clinical trial in two parallel groups (Conventional endoscopic prostatic surgery Vs Partial surgery preserving the prostatic apex.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Non inferiority Comparative single-blinded (patient) multicentre randomised clinical trial in two parallel groups: * Group 1: Conventional endoscopic prostatic surgery * Group 2: Partial surgery preserving the prostatic apex
| Arm | Type | Receives |
|---|---|---|
| Conventional endoscopic prostatic surgery | Experimental | Procedure: Conventional endoscopic prostatic surgeryEndoscopic resection of prostate. |
| Partial surgery preserving the prostatic apex | Experimental | Procedure: Partial surgery preserving the prostatic apexPatients randomised to the partial endoscopic resection group will undergo surgical treatment that preserves the apex area of the prostate (tissue located 1 cm around the veru montanum). |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Man over 40 years old
- Indication of surgical management for BPH
- Prostate volume ≥30 cc and ≤150 cc as evaluated by ultrasonography ( or an MRI if available)
- IPSS score ≥12
- Qmax ≤15 ml/s
Key exclusion criteria (11 listed)
- Unwillingness to accept the treatment
- No pre-operative ejaculation or sexuality
- Neurological pathology responsible for micturition disorders
- History of prostatic surgery
- Stenosis of the urethra symptomatic
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 |
|---|---|---|
| Partial surgery preserving the prostatic apexPartial Endoscopic resection of prostate to conserve apex | Procedure or surgery | Partial surgery preserving the prostatic apex |
| Conventional endoscopic prostatic surgeryEndoscopic resection of prostate. | Procedure or surgery | Conventional endoscopic prostatic surgery |
Primary outcome
Evaluation of IPSS (International Prostatic Symptom Score) score at 6 months
Time frame: 6 months after surgery
the mean IPSS score measured at 6 months, to compare the efficacy of partial endoscopic resection versus complete endoscopic resection in improvement of lower urinary tract symptoms related to BPH. IPSS scores are categorised as 'asymptomatic' (0 points), 'mildly symptomatic' (1-7 points), 'moderately symptomatic' (8-19 points), and 'severely symptomatic' (20-35 points).
8 secondary outcomes
Evaluation of ejaculation and global sexual life
Time frame: 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Evaluation of lower urinary tract symptoms
Time frame: 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Evaluation of complication rates
Time frame: 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Evaluation of ejaculation and global sexual life
Time frame: 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Evaluation of ejaculation and global sexual life
Time frame: 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Evaluation of lower urinary tract symptoms
Time frame: 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Evaluation of lower urinary tract symptoms
Time frame: 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Evaluation of complication rates
Time frame: 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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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.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial surgery preserving the prostatic apex and Conventional endoscopic prostatic surgery in people with Benign Prostatic Hyperplasia, run by University Hospital, Bordeaux at 17 sites in France.
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 9 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grégoire ROBERT (05.57.82.06.87, gregoire.robert@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of IPSS (International Prostatic Symptom Score) score at 6 months (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2026.