MRI-DTI Assessment of Urethral Internal Sphincter Ring and Prostate Base Morphology

ConditionsUrethral Internal Sphincter Morphology Benign Prostatic Hyperplasia Prostate Cancer

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexMale

Age15-90

SponsorJiangsu Taizhou People's Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Contraindications to MRI, including but not limited to incompatible metallic implants, severe claustrophobia, or other conditions preventing MRI examination.

Known neurogenic bladder dysfunction, including spinal cord injury, multiple sclerosis, Parkinson disease, or other neurological disorders that may significantly affect lower urinary tract function.

History of pelvic radiotherapy.

History of urethral reconstruction, sphincter surgery, or other prior surgery that substantially alters the bladder neck, proximal urethra, or prostate base anatomy.

Trial population

The study population will consist of male participants undergoing clinically indicated pelvic, seminal vesicle, or prostate-related MRI-DTI examinations at the study center. The cross-sectional imaging cohort will include a broad spectrum of male participants, including younger men undergoing MRI for suspected cryptorchidism or suspected seminal vesiculitis, as well as middle-aged and older men with benign prostatic enlargement or prostate base morphological changes. This cohort will be used to evaluate the relationship between prostate base morphology and urethral internal sphincter ring morphology. A separate paired follow-up cohort will include patients with prostate cancer who are scheduled to receive androgen deprivation therapy. These participants will undergo MRI-DTI before treatment and during follow-up after ADT to assess whether changes in prostate volume and prostate base morphology are accompanied by corresponding changes in the urethral internal sphincter ring.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

80 Participants

are grouped into 2 trial groups

Group A: Cross-sectional MRI-DTI Cohort

Group B: ADT Paired Follow-up Cohort

Trial outcomes

Primary outcomes

Urethral Internal Sphincter Ring Inner Diameter Measured by MRI-DTI Fiber Tracking

The inner diameter of the reconstructed urethral internal sphincter ring will be measured on fused T2-weighted MRI and DTI images. The measurement will be reported in millimeters.

Time frame