Enlarged Prostate (BPH) Clinical Trials

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An Observational Study of the Relationship Between the Urethral Internal Sphincter Ring and Prostate Base Morphology Using MRI-DTI Fiber Tracking

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

This is a single-center, observational imaging study designed to evaluate the in vivo morphology of the male urethral internal sphincter ring using magnetic resonance diffusion tensor imaging (MRI-DTI) fiber tracking and to investigate its relationship with prostate base morphology. Male participants undergoing clinically indicated pelvic, seminal vesicle, or prostate-related MRI-DTI examinations will be included. The study population may include patients with benign prostatic enlargement, younger men undergoing MRI for suspected cryptorchidism or suspected seminal vesiculitis, and patients with prostate cancer scheduled to receive androgen deprivation therapy (ADT). All participants will undergo T2-weighted imaging and DTI. T2WI-DTI image registration, dual-region-of-interest fiber tracking, and three-dimensional reconstruction will be used to visualize ring-like muscle fiber structures in the bladder neck, prostate base, and proximal urethral region. The cross-sectional imaging cohort will be used to assess the associations between prostate-side morphological parameters, including prostate volume, prostate base diameter or area, and intravesical prostatic protrusion, and sphincter-ring parameters, including ring inner diameter and ring area. The ADT paired cohort will undergo MRI-DTI before treatment and during follow-up after ADT to evaluate whether reduction in prostate volume and prostate base morphology is accompanied by corresponding changes in the urethral internal sphincter ring. This study will not alter the participants' existing clinical diagnostic or treatment pathways. Imaging data will be analyzed using standardized post-processing and quantitative measurement procedures. The results may provide in vivo imaging evidence for age- and prostate-related displacement and morphological remodeling of the male urethral internal sphincter and may inform future surgical strategies for identifying, preserving, or reconstructing proximal urinary continence-related structures.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 15
Maximum Age: 90
Healthy Volunteers: f
View:

• Male participants undergoing clinically indicated pelvic, seminal vesicle, or prostate-related MRI-DTI examination.

• Participants with adequate T2-weighted MRI and DTI data for post-processing and quantitative assessment of the bladder neck, prostate base, and proximal urethral region.

• Participants in the cross-sectional imaging cohort may include men undergoing MRI for suspected cryptorchidism, suspected seminal vesiculitis, benign prostatic enlargement, or other clinically indicated pelvic or prostate-related evaluations.

• Participants in the ADT paired follow-up cohort must have prostate cancer and be scheduled to receive androgen deprivation therapy, with MRI-DTI planned before treatment and during follow-up after ADT.

• Participants must be able to comply with MRI examination procedures.

• Written informed consent will be obtained when required by the approved study protocol.

Locations
Other Locations
China
JiangsuTaizhouPH
RECRUITING
Taizhou
Time Frame
Start Date: 2026-07-15
Estimated Completion Date: 2028-06-01
Participants
Target number of participants: 80
Treatments
Cross-sectional MRI-DTI Cohort
Male participants undergoing clinically indicated pelvic, seminal vesicle, or prostate-related MRI-DTI examinations, including younger men and men with prostate enlargement, will be evaluated cross-sectionally to assess the relationship between prostate base morphology and urethral internal sphincter ring morphology.
ADT Paired Follow-up Cohort
Patients with prostate cancer scheduled to receive androgen deprivation therapy will undergo MRI-DTI before treatment and during follow-up after ADT to evaluate whether changes in prostate base morphology are accompanied by corresponding changes in the urethral internal sphincter ring.
Sponsors
Leads: Jiangsu Taizhou People's Hospital

This content was sourced from clinicaltrials.gov