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
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.
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.
828 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
Browse Prostatic Hyperplasia studies →22 of the 53 studies in Prostatic Hyperplasia with a site in China are open now. Recruiting first, the newest first:
Shanghai General Hospital, China · Sites in China
Ages 50–85 · Men only
Peking University Third Hospital · Sites in China
Men only
Qing Yuan · Sites in China
Ages 40–80 · Men only
Ruijin Hospital · Sites in China
Ages 18–80 · Men only
Chinese PLA General Hospital · Sites in China
Ages 45–85 · Men only
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 →
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.
53 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 2 · Phase 3 5 · Phase 4 3
First in 2004; this study’s year is marked. 11 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 80 is below the median of 250 across 177 observational studies indexed under Prostatic Hyperplasia.
Median enrollment 120 across the 40 interventional studies, 153 across the 13 observational. Of the 22 that completed or were terminated, 5 (23%) have results posted.
This tab as a report to print or save as PDF → With an account.
12 of 53 have an industry lead sponsor. The 10 most frequent:
Jiangsu Taizhou People's Hospital is the lead sponsor of 16 studies on the registry; 15 are open to participants now.
Jiangsu Taizhou People's Hospital has 1 study filed under Prostatic Hyperplasia — fewer than ten, so there is no comparison to draw.
9 of the studies in Prostatic Hyperplasia with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07146386Phase 3Shanghai Huilun Pharmaceutical Co., Ltd.A Phase III Clinical Study of H077 Sustained-Release Tablets Compared With Silodosin Capsules in the Treatment of Benign Prostatic Hyperplasia | 2027-01 |
| NCT07238959Shanghai Changzheng HospitalApplication of Quantum Detection-Driven Artificial Intelligence Algorithms for Single-Molecule cfDNA Characterization in the Early Diagnosis of Prostate Cancer | 2026-12 |
| NCT06817733Chinese PLA General HospitalClinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging | 2026-12-30 |
| NCT07357324The Fourth Affiliated Hospital of Zhejiang University School of MedicineA Clinical Observation Study of a Chinese Patent Medicine Combined With Tamsulosin in Improving Sleep and Nocturia Symptoms After Enucleation of the Prostate | 2026-12-31 |
| NCT06689514Yifeng JingStudy on the Effectiveness of Tranilast in the Treatment of Medium to Large Volume Benign Prostatic Hyperplasia | 2026-12-31 |
Add all 9 to your calendar (.ics) → With an account.
Among the 53 studies in Prostatic Hyperplasia with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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.
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Exclusion Criteria:
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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
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
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
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
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
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
Change From Baseline in Urethral Internal Sphincter Ring Inner Diameter After ADT
Time frame: Baseline and 3 to 6 months after initiation of ADT
Change From Baseline in Urethral Internal Sphincter Ring Area After ADT
Time frame: Baseline and 3 to 6 months after initiation of ADT
Change From Baseline in Prostate Volume After ADT
Time frame: Baseline and 3 to 6 months after initiation of ADT
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.
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Jiangsu Taizhou People's Hospital