Pilot Study of a New Nerve Grafting Method During Bladder Cancer Surgery to Help Preserve Erections.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2029-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This pilot study will evaluate the safety and 1-year erectile function recovery in 10 patients undergoing a novel Nerve Restoring Radical Cystectomy (NR-RC), which includes a genitofemoral nerve graft. Erectile function will be assessed using IIEF-5, SF-MPQ, and CEEF questionnaires at baseline and at multiple post-operative intervals (4 weeks, 3, 6, 12, and 18 months). Safety will be monitored through peri- and post-operative complications, and additional demographic and clinical data will be collected for analysis.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Nerve Grafting Technique to Restore Erectile Function Post Radical Prostatectomy

NCT06458855

Prostate Cancer Erectile Dysfunction Following Radical Prostatectomy

ACTIVE_NOT_RECRUITING NA

Nerve Grafting Technique to Preserve Erectile Function in Patients Undergoing Robotic Assisted Radical Prostatectomy

NCT06521710

Prostate Cancer Erectile Dysfunction

RECRUITING NA

A Study Looking at a New Nerve Surgery to Help Men Regain Erections After Prostate Cancer Surgery

NCT07188064

Prostate Cancer Erectile Dysfunction Following Radical Prostatectomy

NOT_YET_RECRUITING NA

Prostate Capsule Sparing Cystectomy and Nerve-sparing Radical Cystoprostatectomy in Men With Bladder Cancer

NCT01824329

Bladder Cancer Transitional Cell Carcinoma of the Bladder

COMPLETED PHASE2

Effectiveness and Safety of Adipose-derived Regenerative Cells for Reduction of Risk of Bladder Neck Contracture

NCT02869061

Bladder Neck Obstruction Bladder Outlet Obstruction Benign Prostatic Hyperplasia +1 more

UNKNOWN PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bladder Cancer Requiring Cystectomy Erectile Dysfunction Following Radical Prostatectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nerve Restoring Radical Cystectomy.

Patients undergoing radical cystectomy will receive a novel NR-RC procedure using a genitofemoral nerve graft to enhance erectile function recovery.

Group Type EXPERIMENTAL

Patients undergoing radical cystectomy will receive a novel NR-RC procedure using a genitofemoral nerve graft to enhance erectile function recovery.

Intervention Type PROCEDURE

Patients undergoing radical cystectomy will receive a novel NR-RC procedure using a genitofemoral nerve graft to enhance erectile function recovery.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Patients undergoing radical cystectomy will receive a novel NR-RC procedure using a genitofemoral nerve graft to enhance erectile function recovery.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients undergoing standard of care radical cystectomy for bladder cancer
* Patients must have preoperative erectile function with a baseline IIEF score of ≥17

Exclusion Criteria

* Patients with previous pelvic surgery
* Patients with previous pelvic radiotherapy
* Patients aged \< 18 years at diagnosis
* Legally incapable patients
* Patients who are unable to complete questionnaires and have no companion to help complete them
* Patients undergoing a concomitant cancer surgery
* Patients with pre-existing neurologic disease

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No