ClinicalTrials.gg
RecruitingNCT07694752Updated Jul 20, 2026

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

An observational study in Urethral Internal Sphincter Morphology, Benign Prostatic Hyperplasia and Prostate Cancer, sponsored by Jiangsu Taizhou People's Hospital. Recruiting at 1 site in China. Open to male participants aged 15 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-07-20.

Sponsored by Jiangsu Taizhou People's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
15 Years to 90 Years
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 53 studies in Prostatic Hyperplasia with a site in China — 22 open to participants now, 22 under way, 1 of them phase 3. Prostatic Hyperplasia · China.

Planned enrollment
10th of 13
80 · median 153
Started
2026
with 10 others
Observational
13 of 53
5 open now
Primary completion
2027-08
later than 14 of 21 live
Registered
48th of 53
by date

Among the 53 studies in Prostatic Hyperplasia with a site in China, this one is the 10th largest by planned enrollment of the 13 observational ones that give a count, is one of 11 that started in 2026, is one of 13 observational ones, reaches primary completion later than 14 of the 21 other live ones, and was the 48th registered.

Prostatic Hyperplasia

828 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.

Browse Prostatic Hyperplasia studies →

Open to participants now

22 of the 53 studies in Prostatic Hyperplasia with a site in China are open now. Recruiting first, the newest first:

16 more — sign in →

All 22 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 102 Prostatic Hyperplasia studies recruiting now, 70 (69%) set no upper age limit and 4 (4%) stop at 75 or younger; 7 take children under 18; 7 take healthy volunteers.

This study: 15 Years to 90 Years · male · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 53 studies in Prostatic Hyperplasia with a site in China, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Urethral Internal Sphincter Morphology
  • Benign Prostatic Hyperplasia
  • Prostate Cancer

Keywords

  • Diffusion Tensor Imaging
  • Urethral Internal Sphincter
  • Prostate Cancer
04

Who can participate

Ages eligible
15 Years to 90 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male participants undergoing clinically indicated pelvic, seminal vesicle, or prostate-related MRI-DTI examination.
  2. 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.
  3. 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.
  4. 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.
  5. Participants must be able to comply with MRI examination procedures.
  6. Written will be obtained when required by the approved study protocol.

Exclusion criteria

Exclusion Criteria:

  1. to MRI, including but not limited to incompatible metallic implants, severe claustrophobia, or other conditions preventing MRI examination.
  2. Known neurogenic bladder dysfunction, including spinal cord injury, multiple sclerosis, Parkinson disease, or other neurological disorders that may significantly affect lower urinary tract function.
  3. History of pelvic radiotherapy.
  4. History of urethral reconstruction, sphincter surgery, or other prior surgery that substantially alters the bladder neck, proximal urethra, or prostate base anatomy.
  5. Severe cardiopulmonary dysfunction, cognitive impairment, psychiatric disorder, or other conditions preventing cooperation with MRI examination or study procedures.
  6. 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.
  7. Poor image quality or failed post-processing that prevents reliable visualization or measurement of the urethral internal sphincter ring.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  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.

    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

  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.

    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

Secondary outcomes

  1. Prostate Base Diameter Measured on T2-Weighted MRI

    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

  2. Prostate Base Area Measured on T2-Weighted MRI

    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

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

    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

  4. Prostate Volume Calculated From T2-Weighted MRI

    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

Other outcomes

  1. Change From Baseline in Urethral Internal Sphincter Ring Inner Diameter After ADT

    Time frame: Baseline and 3 to 6 months after initiation of ADT

  2. Change From Baseline in Urethral Internal Sphincter Ring Area After ADT

    Time frame: Baseline and 3 to 6 months after initiation of ADT

  3. Change From Baseline in Prostate Volume After ADT

    Time frame: Baseline and 3 to 6 months after initiation of ADT

07

Study locations

1 of 1 sites recruiting
  • JiangsuTaizhouPH
    Taizhou, Jiangsu, China
    Recruiting
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2026; primary completion for Aug 2027, 12 months later.

Of 59 non-industry observational studies under Prostatic Hyperplasia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 50. This study's planned 12 months is below that.

Counting every sponsor, half of 74 studies reached it within 25 months; a quarter within 12 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 6, 2026
First posted
Jul 10, 2026
StartEst.
Jul 15, 2026
Primary completionEst.
Aug 1, 2027
CompletionEst.
Jun 1, 2028
Last update
Jul 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07694752
Lead sponsor
Jiangsu Taizhou People's Hospital
Responsible party
Sponsor
First posted
Jul 10, 2026
Start date
Jul 15, 2026 (estimated)
Primary completion
Aug 1, 2027 (estimated)
Completion
Jun 1, 2028 (estimated)
Last update
Jul 20, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion