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New trial tests smarter bladder cancer surgery to save Men's sexual health

NCT ID NCT05792722

Symptom relief Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two surgical approaches for removing the bladder in men with bladder cancer: prostate capsule-sparing and nerve-sparing. The goal is to see which technique better preserves erectile function and urinary control. Seventy men will be randomly assigned to one of the two procedures and will complete questionnaires about their sexual and urinary health over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Prostate capsule-sparing radical cystectomy and nerve-sparing radical cystectomy
What this could lead to
If successful, this could show that a prostate-sparing surgery helps men maintain better erectile and urinary function after bladder removal, without increasing cancer risk.
What could go wrong
This is a small, early-stage trial (70 participants) comparing two surgical procedures. It is not testing a new drug or cure, and results may not apply to all bladder cancer patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects with pathologically confirmed bladder cancer scheduled for radical cystectomy * Variant histologies of bladder cancer permitted * Neoadjuvant therapy permitted * Age \> 18 years old * Ability to understand and willingness to sign a written informed consent document Exclusion Criteria: * Patients that are not candidates for cystectomy * Moderate to severe erectile dysfunction with SHIM score \<17 * Bladder cancer with bladder neck or prostatic involvement, including cancer in the prostatic urethra * Prior pelvic radiation * Confirmed prostate cancer: * Patients with abnormal Digital rectal exam (DRE), PSA \>3 or Prostate Imaging Reporting \& Data System (PIRADS) 4 lesions on prostate Multiparametric MRI (mpMRI) will undergo prostate biopsy to rule out prostate cancer * Increased genetic risk of prostate cancer per National Comprehensive Cancer Network (NCCN) guidelines: * ≥1 first-, second-, or third-degree relative with: breast cancer at age ≤50 y, colorectal or endometrial cancer at age ≤50 y, male breast cancer at any age, ovarian cancer at any age, exocrine pancreatic cancer at any age, metastatic, regional, very-high-risk, high-risk prostate cancer at any age * ≥1 first-degree relative (father or brother) with: prostate cancer at age ≤60 y * ≥2 first-, second-, or third-degree relatives with: breast cancer at any age, prostate cancer at any age * ≥3 first- or second-degree relatives with: Lynch syndrome-related cancers, especially if diagnosed * Patients with Lynch syndrome

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Conditions

The condition(s) this trial relates to.

urinary bladder carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bladder cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Sibley Memorial Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20016, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.