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Urethral Internal Sphincter MorphologyNCT07694752

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

An observational study of Urethral Internal Sphincter Morphology and Benign Prostatic Hyperplasia, run by Jiangsu Taizhou People's Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 90 years, men only
How many people
80 participants
Where
1 siteChina
Study dates
15 Jul 2026to 1 Jun 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 90 years
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Study 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.

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • Severe cardiopulmonary dysfunction, cognitive impairment, psychiatric disorder, or other conditions preventing cooperation with MRI examination or study procedures.
  • Use of medications or treatments within the previous 3 months that may substantially affect neuromuscular function of the lower urinary tract, as judged by the investigators.
  • Poor image quality or failed post-processing that prevents reliable visualization or measurement of the urethral internal sphincter ring.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • JiangsuTaizhouPH

    Taizhou, Jiangsu

    振 张, +86-19156677214, 19156677214@163.com

    Recruiting

Other trials in China

About this study

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

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.

Read more

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.

Read the detailed description

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 the relationship between sphincter-ring morphology and prostate base morphology.

Post-prostatectomy urinary incontinence remains an important functional complication affecting quality of life in male patients. Although bladder neck preservation and continence-related reconstructive techniques are widely used in prostate surgery, direct in vivo imaging evidence demonstrating whether these approaches preserve or reconstruct the urethral internal sphincter remains limited. Conventional anatomical descriptions generally place the male internal sphincter in the bladder neck and proximal urethral region. However, clinical observations suggest that in men with prostate enlargement, protrusion of the prostate base, or marked changes in the bladder outlet region, a clearly defined ring-like smooth muscle structure may not be identifiable at the bladder neck. This raises the possibility that the location and morphology of the internal sphincter may change in association with prostate growth and remodeling of the prostate base.

MRI-DTI is an imaging technique that uses directional water diffusion to infer tissue fiber orientation and to reconstruct local fiber trajectories. In this study, DTI fiber tracking will be combined with T2-weighted imaging to visualize ring-like muscle fiber structures in the bladder neck, prostate base, and proximal urethral region. T2-weighted imaging will provide anatomical reference for the prostate, bladder neck, and proximal urethra, while DTI data will be used for fiber tracking and three-dimensional reconstruction of the urethral internal sphincter ring.

The study will include male participants undergoing clinically indicated pelvic, seminal vesicle, or prostate-related MRI-DTI examinations. The cross-sectional imaging cohort will include a broad range of male participants rather than only patients with benign prostatic hyperplasia. This cohort may include younger men undergoing MRI for suspected cryptorchidism or suspected seminal vesiculitis, as well as older men with benign prostatic enlargement or prostate base enlargement. This design is intended to capture a wider spectrum of prostate size, prostate base morphology, and urethral internal sphincter-ring morphology. A separate paired follow-up cohort will include patients with prostate cancer scheduled to receive androgen deprivation therapy (ADT), with MRI-DTI performed before treatment and during follow-up after ADT.

All imaging data will be processed using a standardized post-processing workflow. T2-weighted images and DTI datasets will be co-registered. The bladder neck, prostate base, and proximal urethral region will be identified on fused T2WI-DTI images. Two elliptical regions of interest will be placed anterior and posterior to the urethral region, and fiber tracts passing through both regions of interest will be selected to reconstruct the target ring-like fiber structure. The fused images will be used for quantitative measurements, and three-dimensional fiber models will be used for morphological visualization and representative case demonstration.

The main prostate-side morphological parameters will include prostate volume, intravesical prostatic protrusion, prostate base diameter, and prostate base area when technically feasible. Prostate volume will be calculated from T2-weighted images using standard three-dimensional measurements and an ellipsoid formula. Intravesical prostatic protrusion will be measured on sagittal T2-weighted images. Prostate base diameter and area will be measured at predefined anatomical levels based on the bladder neck and prostate base. The main sphincter-ring parameters will include the inner diameter and area of the urethral internal sphincter ring. Exploratory DTI-derived parameters, such as fractional anisotropy and mean diffusivity, may be recorded when the reconstructed fiber structure is technically stable and measurable.

In the cross-sectional cohort, the primary analysis will evaluate the association between prostate base morphology and urethral internal sphincter-ring morphology. Correlations will be assessed between prostate volume, prostate base diameter, prostate base area, intravesical prostatic protrusion, and sphincter-ring inner diameter or area. This analysis is intended to determine whether prostate enlargement or local remodeling of the prostate base is associated with expansion, displacement, or morphological remodeling of the internal sphincter ring.

In the ADT paired cohort, imaging parameters will be compared before and after androgen deprivation therapy. Changes in prostate volume, prostate base diameter, prostate base area, intravesical prostatic protrusion, and sphincter-ring diameter or area will be calculated. The study will further evaluate whether reduction in prostate volume and prostate base morphology after ADT is accompanied by corresponding changes in the urethral internal sphincter ring. Change values and percentage changes will be used to assess the relationship between prostate regression and sphincter-ring remodeling.

This study will not assign treatment or alter the participants' existing clinical diagnostic or therapeutic pathways. Imaging examinations will be performed in participants who undergo MRI for clinical indications or planned follow-up. The study will focus on image post-processing, quantitative measurement, and statistical analysis of MRI-DTI data. Participants with neurological bladder dysfunction, prior pelvic radiotherapy, prior urethral reconstruction or sphincter surgery, contraindications to MRI, or inadequate image quality for sphincter-ring assessment will be excluded.

Continuous variables will be summarized according to their distribution. Normality will be assessed using appropriate statistical tests and visual inspection when applicable. Correlations between prostate-side and sphincter-ring parameters will be evaluated using Pearson or Spearman correlation analysis according to data distribution. In the ADT cohort, paired comparisons will be performed using paired t-tests or Wilcoxon signed-rank tests as appropriate. Associations between changes in prostate morphology and changes in sphincter-ring morphology will also be assessed using correlation analysis. A two-sided P value of less than 0.05 will be considered statistically significant.

The study is expected to provide in vivo imaging evidence regarding the relationship between prostate base morphology and urethral internal sphincter-ring morphology. The findings may improve understanding of age- and prostate-related displacement and remodeling of the male internal sphincter and may provide imaging support for future surgical strategies aimed at identifying, preserving, or reconstructing proximal urinary continence-related structures during prostate surgery.

Keywords
Diffusion Tensor Imaging, Urethral Internal Sphincter, Prostate Cancer
Medical subject headings
Prostatic Hyperplasia, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07694752
Study groupRoleWhat they receive
Cross-sectional MRI-DTI CohortMale 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 CohortPatients 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At baseline MRI for the cross-sectional cohort; at baseline and 3 to 6 months after initiation of ADT for the paired follow-up cohort

  2. Urethral Internal Sphincter Ring Area Measured by MRI-DTI Fiber Tracking

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

    Measured: At baseline MRI for the cross-sectional cohort; at baseline and 3 to 6 months after initiation of ADT for the paired follow-up cohort

Secondary outcomes (4)
  1. Prostate Base Diameter Measured on T2-Weighted MRI

    Measured: At baseline MRI for the cross-sectional cohort; at baseline and 3 to 6 months after initiation of ADT for the paired follow-up cohort

  2. Prostate Base Area Measured on T2-Weighted MRI

    Measured: At baseline MRI for the cross-sectional cohort; at baseline and 3 to 6 months after initiation of ADT for the paired follow-up cohort

  3. Intravesical Prostatic Protrusion Measured on Sagittal T2-Weighted MRI

    Measured: At baseline MRI for the cross-sectional cohort; at baseline and 3 to 6 months after initiation of ADT for the paired follow-up cohort

  4. Prostate Volume Calculated From T2-Weighted MRI

    Measured: At baseline MRI for the cross-sectional cohort; at baseline and 3 to 6 months after initiation of ADT for the paired follow-up cohort

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2026
  2. Study start15 Jul 2026 (estimated)
  3. Primary completion1 Aug 2027 (estimated)
  4. Study completion1 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07694752
Sponsor's protocol ID
LSKY 2026-048-01
Status last verified
Jul 2026
First submitted
6 Jul 2026
Last updated
20 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Xu Z, Zhao J, Guan Z, Guo M, Bian H, Li Z, Zhao W, Liang S, Liu Y, Zhang S, Wang J. Internal urethral sphincter reconstruction with anterior bladder neck tube for robotic and laparoscopic radical prostatectomy: improving early return of continence. Transl Androl Urol. 2024 Jun 30;13(6):994-1003. doi: 10.21037/tau-23-583. Epub 2024 Jun 26.

    PubMed 38983476
  • Hotker AM, Mazaheri Y, Zheng J, Moskowitz CS, Berkowitz J, Lantos JE, Pei X, Zelefsky MJ, Hricak H, Akin O. Prostate Cancer: assessing the effects of androgen-deprivation therapy using quantitative diffusion-weighted and dynamic contrast-enhanced MRI. Eur Radiol. 2015 Sep;25(9):2665-72. doi: 10.1007/s00330-015-3688-1. Epub 2015 Mar 29.

    PubMed 25820537
  • Mason M, Maldonado Pijoan X, Steidle C, Guerif S, Wiegel T, van der Meulen E, Bergqvist PB, Khoo V. Neoadjuvant androgen deprivation therapy for prostate volume reduction, lower urinary tract symptom relief and quality of life improvement in men with intermediate- to high-risk prostate cancer: a randomised non-inferiority trial of degarelix versus goserelin plus bicalutamide. Clin Oncol (R Coll Radiol). 2013 Mar;25(3):190-6. doi: 10.1016/j.clon.2012.09.010. Epub 2012 Dec 17.

    PubMed 23257248
  • Hikita K, Honda M, Teraoka S, Nishikawa R, Kimura Y, Tsounapi P, Iwamoto H, Morizane S, Takenaka A. Intravesical prostatic protrusion may affect early postoperative continence undergoing robot-assisted radical prostatectomy. BMC Urol. 2020 Oct 21;20(1):164. doi: 10.1186/s12894-020-00740-0.

    PubMed 33087082
  • Verde ASC, Santinha J, Carrasquinha E, Loucao N, Gaivao A, Fonseca J, Matos C, Papanikolaou N. Diffusion tensor-based fiber tracking of the male urethral sphincter complex in patients undergoing radical prostatectomy: a feasibility study. Insights Imaging. 2020 Nov 27;11(1):126. doi: 10.1186/s13244-020-00927-x.

    PubMed 33245443
  • Sinha S, Sinha U, Malis V, Bhargava V, Sakamoto K, Rajasekaran M. Exploration of male urethral sphincter complex using diffusion tensor imaging (DTI)-based fiber-tracking. J Magn Reson Imaging. 2018 Oct;48(4):1002-1011. doi: 10.1002/jmri.26017. Epub 2018 Mar 23.

    PubMed 29573022
  • Koraitim MM. The male urethral sphincter complex revisited: an anatomical concept and its physiological correlate. J Urol. 2008 May;179(5):1683-9. doi: 10.1016/j.juro.2008.01.010. Epub 2008 Mar 17.

    PubMed 18343449
  • Kim JW, Kim DK, Ahn HK, Jung HD, Lee JY, Cho KS. Effect of Bladder Neck Preservation on Long-Term Urinary Continence after Robot-Assisted Laparoscopic Prostatectomy: A Systematic Review and Meta-Analysis. J Clin Med. 2019 Nov 24;8(12):2068. doi: 10.3390/jcm8122068.

    PubMed 31771310

Questions about this trial

What is this clinical trial studying?

An observational study of Urethral Internal Sphincter Morphology and Benign Prostatic Hyperplasia, run by Jiangsu Taizhou People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urethral Internal Sphincter Ring Inner Diameter Measured by MRI-DTI Fiber Tracking (time frame: At baseline MRI for the cross-sectional cohort; at baseline and 3 to 6 months after initiation of ADT for the paired follow-up cohort). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07694752, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

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