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Efficacy and Safety of Penile Prosthesis Implantation in Neurogenic Lower Urinary Tract Dysfunction with Erectile Dysfunction

Efficacy and Safety of Penile Prosthesis Implantation in Neurogenic Lower Urinary Tract Dysfunction with Erectile Dysfunction

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500108385
Enrollment
Unknown
Registered
2025-08-29
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neurogenic lower urinary tract dysfunction concomitant with erectile dysfunction

Interventions

Observation group:None

Sponsors

China Rehabilitation Research Center
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Neurological disease. 2. Neurogenic lower urinary tract dysfunction complicated by neurogenic erectile dysfunction. 3. Severe erectile dysfunction refractory to non-surgical therapies, including pharmacologic and rehabilitative interventions.

Exclusion criteria

Exclusion criteria: 1. Extensive bilateral corporal fibrosis or marked congenital penile shortening. 2. Contraindication to the rifampin/minocycline-coated InhibiZone™ AMS 700™ prosthesis, i.e., known hypersensitivity to rifampin, minocycline, or any tetracycline-class antibiotic. 3. Unresolved structural lower urinary tract disease scheduled or anticipated to require surgical correction. 4. Severe systemic disease: advanced heart, lung, hepatic, or renal failure; terminal malignancy; severe coagulopathy or systemic bleeding diathesis; uncontrolled major neurologic or psychiatric disorders. 5. Any other serious condition judged by the investigator to preclude study participation, such as uncontrolled infection or comorbidities likely to interfere with study conduct or outcomes.

Design outcomes

Primary

MeasureTime frame
Erection dysfunction inventory of treatment satisfaction,EDITS;

Secondary

MeasureTime frame
International index for erectile function, IIEF;voiding diary;maximum cystometric capacity ;bladder compliance; urinary flow rate;post-void residual urine;

Countries

China

Contacts

Public ContactZhang Fan

China Rehabilitation Research Center

zhangfan0207@126.com+86 135 2058 5710

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026