Urinary DysfunctionNCT06637852
Sexual and Urinary Function Improvement for Cancer Survivors
A study testing SUFICS-PACT in people with Urinary Dysfunction and Sexual Dysfunction, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to test the efficacy of SUFICS-PACT to identify and treat sexual and urinary dysfunction in prostate cancer survivors at NYC H+ H/Bellevue, the oldest public hospital in the US. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Dysfunction, Sexual Dysfunction
- What is being tested?
- SUFICS-PACT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 31 Mar 2030
- Phase
- Interventional
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Have a diagnosis of prostate cancer
- Have sought care/treatment for prostate cancer
Who cannot join
- Patients under 18 years old
- Patients who have not sought care/treatment for prostate cancer
- Patients who are categorized as "vulnerable subjects," such as minors or incarcerated individuals.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Sexual and Urinary Function Improvement for Cancer Survivors- Promoting Access to Collaborative Treatment (SUFICS-PACT)
The purpose of this study is to test the efficacy of SUFICS-PACT to identify and treat sexual and urinary dysfunction in prostate cancer survivors at NYC H+ H/Bellevue, the oldest public hospital in the US. This study will evaluate the implementation of an adapted sexual and urinary function collaborative care model at NYC Health+Hospitals/Bellevue. The study will test the efficacy of this collaborative care model through a randomized controlled trial in the adult primary care clinic; the intervention arm will receive collaborative treatment consisting of a care manager who has specialty training in mental health and psychosexual counseling, a primary care nurse practitioner who leads symptom management, primary care physicians who supervise the team, and a team specialty consult liaison.
- Conditions
- Urinary Dysfunction, Sexual Dysfunction
- Being tested
- SUFICS-PACT
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUFICS-PACTBehavioural
SUFICS-PACT includes sexual and urinary dysfunction screening, collaborative treatment of sexual and urinary dysfunction, and care managers who are mental health professionals with training in psychosexual counseling. Mental health professionals will facilitate a comprehensive approach to sexual dysfunction, as emphasized by the biopsychosocial model of sexual health. SUFICS-PACT also emphasizes close follow up, which is important for sexual function recovery after prostate cancer treatment.
| Study group | Role | What they receive |
|---|---|---|
| SUFICS-PACT | Experimental | The Sexual and Urinary Function Improvement for Cancer Survivors- Promoting Access to Collaborative Treatment (SUFICS-PACT) intervention integrates a collaborative care model in primary care to facilitate problem identification, comprehensive treatment, and close follow-up for sexual and urinary dysfunction. Receives: Behavioral: SUFICS-PACT |
| Usual care | No intervention | Participants assigned to this group will continue with usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients identified and treated for sexual dysfunction
Measured: Year 5
Number of patients identified and treated for urinary dysfunction
Measured: Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2029 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary DysfunctionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nnenaya A. Mmonu, MD, MS, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637852
- Sponsor's protocol ID
- 23-00945
- Status last verified
- Jul 2026
- First submitted
- 10 Oct 2024
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Nnenaya.Mmonu@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual and Urinary Function Improvement for Cancer Survivors- Promoting Access to Collaborative Treatment (SUFICS-PACT)
- ClinicalTrials.gov ID
- NCT06637852
- Acronym / sponsor ID
- 23-00945
- Conditions
- Urinary Dysfunction, Sexual Dysfunction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the efficacy of SUFICS-PACT to identify and treat sexual and urinary dysfunction in prostate cancer survivors at NYC H+ H/Bellevue, the oldest public hospital in the US. This study will evaluate the implementation of an adapted sexual and urinary function collaborative care model at NYC Health+Hospitals/Bellevue. The study will test the efficacy of this collaborative care model through a randomized controlled trial in the adult primary care clinic; the intervention arm will receive collaborative treatment consisting of a care manager who has specialty training in mental health and psychosexual counseling, a primary care nurse practitioner who leads symptom management, primary care physicians who supervise the team, and a team specialty consult liaison.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SUFICS-PACT | Experimental | Behavioral: SUFICS-PACTThe Sexual and Urinary Function Improvement for Cancer Survivors- Promoting Access to Collaborative Treatment (SUFICS-PACT) intervention integrates a collaborative care model in primary care to facilitate problem identification, comprehensive treatment, and close follow-up for sexual and urinary dysfunction. |
| Usual care | No intervention | –Participants assigned to this group will continue with usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years old
- Have a diagnosis of prostate cancer
- Have sought care/treatment for prostate cancer
Key exclusion criteria (3 listed)
- Patients under 18 years old
- Patients who have not sought care/treatment for prostate cancer
- Patients who are categorized as "vulnerable subjects," such as minors or incarcerated individuals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUFICS-PACTSUFICS-PACT includes sexual and urinary dysfunction screening, collaborative treatment of sexual and urinary dysfunction, and care managers who are mental health professionals with training in psychosexual counseling. Mental health professionals will facilitate a comprehensive approach to sexual dysfunction, as emphasized by the biopsychosocial model of sexual health. SUFICS-PACT also emphasizes close follow up, which is important for sexual function recovery after prostate cancer treatment. | Behavioural | SUFICS-PACT |
Primary outcome
Number of patients identified and treated for sexual dysfunction
Time frame: Year 5
Number of patients identified and treated for urinary dysfunction
Time frame: Year 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Nnenaya.Mmonu@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nnenaya A. Mmonu, MD, MS principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SUFICS-PACT in people with Urinary Dysfunction and Sexual Dysfunction, run by NYU Langone Health at 1 site in United States.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 30 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 United States. 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?
Contact Nnenaya Mmonu, MD, MS (646-825-6300, Nnenaya.Mmonu@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients identified and treated for sexual dysfunction (time frame: Year 5). 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?
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 30 Jul 2026.