An observational study in Radical Prostatectomy, Erectile Dysfunction Following Radical Prostatectomy and Erectile Dysfunction Due to Arterial Insufficiency, sponsored by University College, London. Recruiting at 1 site in United Kingdom. Open to male participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by University College, London · Observational
Prostate cancer is the most common cancer amongst men in the United Kingdom, and two common curative treatments are surgery to remove the prostate (radical prostatectomy) or radiotherapy. Both treatments can affect quality of life, mainly because of problems with erections and urinary leakage. Many men feel disappointed or regret their treatment choice because of changes in their sexual function. Surgeons often use a 'nerve-sparing' technique to reduce the risk of erectile dysfunction (ED), but many men still experience erection problems afterwards. A way to improve erectile function recovery after surgery further would be to identify accessory (additional) arteries to the penis. Up to one in three men have an extra artery called the accessory pudendal artery (APA). Preserving this artery during surgery may improve recovery of erections by protecting blood flow and reducing the risk or severity of ED. Until recently, surgeons could only try to see these arteries during the operation, and no study has tested whether they are preserved or whether this makes a difference. This has changed with the advent of imaging. Men already have an advanced MRI scan (called a multiparametric MRI) before prostate cancer treatment. These scans can also show whether an APA is present. In addition, robotic surgery, now the gold standard for radical prostatectomy, allows operations to be video recorded. This allows comparison of what was seen on the scan with what happened during surgery and then monitoring of recovery afterwards. Early research suggests that men with an APA have better erections before surgery. This study will test whether preserving the APA during surgery helps erections recover afterwards.
In this first phase of the research (Phase 1), a feasibility study will be carried out at University College London Hospital. The study will invite 20-40 men with good sexual function before surgery, who are having robotic prostatectomy with a nerve-sparing approach. Multiparametric MRI scans will be used to identify whether an APA is present and video recordings will be collected to see if the artery was preserved. Participants will complete simple questionnaires on erections and quality of life before and after surgery up to 1 year. To assess whether the artery was preserved, an extra MRI scan will be organised after surgery for those with an APA, as well as penile ultrasound to assess erectile machinery. Ethical approval has already been obtained from the regulatory bodies, and the study is ready to start recruiting participants.
The results will allow planning of a larger, national study (Phase 2). That study will test whether preserving the APA improves erectile recovery, reduces the severity of ED, and improves quality of life. If confirmed, this research could lead to modification in surgical approach, more personalised counselling before surgery, and reduced long-term need for costly ED treatments within the NHS.
Prostate cancer is the most common cancer among men in the UK and the second leading cause of cancer-related deaths, with over 55,000 new cases diagnosed each year. It is a major health concern, but when caught early, localized prostate cancer can often be treated successfully. Treatments such as surgery (radical prostatectomy) or radiotherapy aim to cure the disease. Over the years, imaging techniques have advanced significantly. A specialized scan called multi-parametric MRI (mpMRI) is now routinely used to diagnose prostate cancer and to guide biopsies, allowing doctors to precisely target areas of concern.
Despite these advances, prostate cancer surgery, even with modern robotic-assisted techniques, can have long-lasting side effects. These include erectile dysfunction (ED) and urinary incontinence, both of which can have a significant impact on a patient's quality of life. In fact, poor sexual function is one of the most commonly reported problems after surgery, affecting many patients' mental and emotional wellbeing. Every year, around 8,000 men undergo radical prostatectomy in England through the NHS, and the majority experience some degree of these side effects.
Surgical techniques such as neurovascular bundle (NVB) sparing are designed to protect the nerves and blood vessels around the prostate that are critical for erectile function. However, recovery of erectile function after NVB-sparing surgery is unpredictable, and many patients do not regain their full sexual function. The reasons for this are not fully understood. Some experts believe that erectile dysfunction may be due to damage to blood vessels, while others suggest nerve damage is the primary cause. It's likely that both factors play a role.
One overlooked issue might be variations in pelvic anatomy. In up to 38% of men, the blood vessels that supply the penis-such as the accessory pudendal arteries (APAs)-can be in different locations than expected. These variations are often not considered during conventional nerve-sparing procedures, which focus on preserving structures behind the prostate. If these additional arteries are damaged or removed during surgery, it could contribute to erectile dysfunction.
Fortunately, new tools offer the potential to address this. High-resolution mpMRI scans, which are already part of the standard diagnostic process for prostate cancer, can map the location of these blood vessels before surgery. Additionally, robotic-assisted surgery allows surgeons to record the entire operation in detail. By analyzing these recordings alongside the pre-surgery MRI scans and post-surgery outcomes, researchers can better understand how preserving these arteries affects recovery of erectile function.
This is feasibility study aims to explore whether identifying and preserving accessory pudendal arteries during surgery can improve erectile function outcomes for prostate cancer patients. The goal is to assess whether it's feasible to incorporate these imaging and surgical techniques into regular practice. If successful, this research could guide surgeons in refining their methods, help patients make better-informed decisions, and ultimately improve recovery outcomes for men undergoing prostate cancer surgery.
This is a prospective, single-centre, non-interventional feasibility study evaluating functional and imaging outcomes in patients with localized prostate cancer undergoing bilateral neurovascular bundle (NVB)-sparing robotic-assisted radical prostatectomy (RARP) at University College London Hospitals.
The study will recruit 20-40 sexually active men, aged 18 years or older, with good baseline erectile function (IIEF-EF ≥24). All procedures will be performed by one of four designated surgeons (Mr Zafer Tandogdu, Mr Ben Lamb, Mr Ashwin Sridhar, Prof Greg Shaw) to minimise surgical variability.
Data collection: Demographics, medical history, and preoperative multi-parametric MRI (mpMRI) parameters will be recorded. Functional outcomes will be assessed using validated Patient-Reported Outcome Measures (PROMs) at baseline, 6 weeks, 6 months, and 12 months post-surgery. Standard UCLH andrology follow-up will continue, with optional telephone consultations instead of clinic visits.
Additional assessments:
Surgical quality assessment: Intraoperative videos (routine recordings made for training) will capture only the operative field, excluding identifiable patient features. These anonymised recordings will be securely stored and reviewed by high-volume surgeons for assessment of surgical technique. Theatre staff consent procedures have been implemented to address GDPR and confidentiality.
Participation is entirely voluntary. The aim is to assess the feasibility of recruitment, data collection, and follow-up procedures to inform a larger future study.
The aim of this project is to assess the feasibility and acceptability of conducting a full-scale observational study that investigates whether imaging-detected accessory pudendal arteries (APAs) influence erectile function outcomes following nerve-sparing robot-assisted radical prostatectomy (RARP).
In other words, the main goal of this feasibility study is to test whether it is possible and practical to run a larger future study. The investigators will explore whether men can be successfully recruited and followed up, and whether imaging and surgical data can be collected and analysed in a reliable way. This will lay the groundwork for a definitive study on whether preserving APAs affects erectile recovery after prostate surgery.
701 studies on the registry are indexed under Erectile Dysfunction; 125 are open to participants now.
This study's planned enrollment of 40 is below the median of 130 across 125 observational studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →University College, London is the lead sponsor of 651 studies on the registry; 149 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with localised prostate cancer undergoing radical prostatectomy with bilateral nerve sparing.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with good baseline erectile function undergoing bilateral nerve spare radical prostatectomy for localised prostate cancer.
Procedure: Robotic Radical Prostatectomy · Diagnostic Test: Penile doppler ultrasound
Bilateral nerve spare radical prostatectomy
Stimulated PDUS to assess erectile machinery after ertogenic intracavernosal injection before and after robotic radical prostatectomy
Number of Participants Enrolled During the Recruitment Period
Number of eligible participants who provide informed consent and are enrolled in the study during the 12-month recruitment period.
Time frame: 12 months
Percentage of Participants Completing Follow-up Through 12 Months
Percentage of enrolled participants who complete all scheduled post-operative follow-up assessments up to 12 months after surgery.
Time frame: 12 months
Percentage of Participants With Accessory Pudendal Artery Identified on Pre-operative mpMRI
Percentage of participants in whom an accessory pudendal artery (APA) is identified and mapped on pre-operative multiparametric MRI imaging.
Time frame: 12 months
Percentage of Participants With Complete Intraoperative Video Recording Available for APA Assessment
Percentage of participants with intraoperative surgical video recordings of sufficient quality to allow evaluation of accessory pudendal artery preservation.
Time frame: 12 months
Percentage of Cases With Determinable APA Preservation Status on Video Review
Percentage of recorded surgeries in which accessory pudendal artery preservation status (preserved vs not preserved) can be determined by intraoperative video analysis.
Time frame: 12 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Started Jan 2026 (actual). Primary completion is estimated for Jul 2027, 18 months after the start.
Of 40 observational studies under Erectile Dysfunction, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 77. This study's planned 18 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.