Bladder CancerSPICENCT07339761
Supporting Sexual Health in Bladder Cancer Patients: A Sequential Mixed-Methods Intervention Study
A study testing Sexological Support in people with Bladder Cancer and Non-Muscle-Invasive Bladder Cancer (NMIBC), run by University of Aarhus at 1 site in Denmark.
Trial summary
Despite increasing recognition of sexual dysfunction and sexual distress as important survivorship issues in oncology, research and clinical attention remain uneven across cancer types. This imbalance is particularly evident in bladder cancer, where sexual health has received limited research and clinical attention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Non-Muscle-Invasive Bladder Cancer (NMIBC), Muscle-Invasive Bladder Carcinoma
- What is being tested?
- Sexological Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2026to 31 Aug 2028
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant has one of the following diagnoses and received initial treatment approximately 12 months ago:
- Non-muscle-invasive bladder cancer treated with transurethral resection of the bladder (TUR-B)
- Non-muscle-invasive bladder cancer treated with TUR-B and subsequent intravesical instillation therapy with chemotherapy or immunotherapy
- Muscle-invasive bladder cancer treated with cystectomy (removal of the bladder)
- The participant has experienced changes and/or difficulties in sexual function related to the cancer diagnosis and/or its treatment
- The participant speaks and understands Danish
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- The participant is aged 18 years or older
- The participant has read and understood the oral and written study information
- The participant has provided written informed consent
- The participant is diagnosed with Muscle-invasive bladder cancer treated with cystectomy (removal of the bladder)
- The participant speaks and understands Danish
- The participant is aged 18 years or older
- The participant has read and understood the oral and written study information
- The participant has provided written informed consent
Who cannot join
- The participant has a history of other cancers located in the pelvic region, including rectal cancer, sarcomas, uterine cancer, cervical cancer, ovarian cancer, prostate cancer, or penile cancer
- The participant has a history of breast cancer
- The participant has a history of other cancers located in the pelvic region, including rectal cancer, sarcomas, uterine cancer, cervical cancer, ovarian cancer, prostate cancer, or penile cancer
- The participant has a history of breast cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Urology, Aarhus University Hospital
Aarhus, 8200
About this study
Official title: SPICE: Supporting Sexual Health in Bladder Cancer Patients: A Sequential Mixed-Methods Intervention Study
Despite increasing recognition of sexual dysfunction and sexual distress as important survivorship issues in oncology, research and clinical attention remain uneven across cancer types. This imbalance is particularly evident in bladder cancer, where sexual health has received limited research and clinical attention. However, existing studies demonstrate substantial sexual dysfunction and reduced intimacy among patients following disease and treatment.
The treatment of bladder cancer is a multimodal and multidisciplinary discipline. Low-risk non-muscle-invasive bladder cancer (NMIBC) is treated by transurethral resection of the bladder (TURB) alone, while recurrent intermediate- and high-risk NMIBC undergo a combination of TURB and adjuvant intravesical instillation therapy. For patients with muscle-invasive bladder cancer (MIBC) and specific high-risk NMIBC cases, the first-line treatment option is radical cystectomy with urinary diversion, with or without neoadjuvant chemotherapy.
Read more
These treatment modalities are known to have a negative impact on sexual function, and studies in both men and women demonstrate profound impairments in sexual function, intimacy, and body image after treatment. Among men, erectile and ejaculatory dysfunction are prevalent for this patient group and frequently associated with diminished sexual satisfaction and body-image concerns. Likewise, women experience loss of sexual desire, orgasmic disorders, dyspareunia, and vaginal dryness following cystectomy.
A targeted literature search further identified no contemporary sexology-focused interventional or feasibility trials specifically in bladder cancer (neither MIBC or NMIBC). Existing evidence on the topic is largely descriptive or addresses non-sexological rehabilitation, demonstrating a evidence gap[1].
Qualitative research has also explored informational and psychosocial needs among bladder cancer patients, revealing limited communication about sexual health and unmet needs for professional support. Such studies provide valuable insight into patient experiences but have not yet translated this knowledge into the development of structured, sexological interventions.
Evidence from other cancer populations demonstrates that counselling and psychoeducational programmes addressing intimacy and sexuality are both feasible and beneficial, suggesting that similar interventions could be adapted for bladder cancer care.
To develop a relevant and acceptable intervention, it is essential to understand how patients themselves perceive their sexual health challenges, informational needs, and preferences for professional support regarding sexual health.
This project therefore consists of two sequential sub-studies:
- Study 1a (Development phase): A qualitative, exploratory study to develop a sexological intervention with patient and clinician involvement.
- Study 1b (Feasibility phase): A one-armed feasibility trial assessing the implementation and acceptability of the intervention among patients with muscle-invasive bladder cancer (MIBC).
- Conditions
- Bladder Cancer, Non-Muscle-Invasive Bladder Cancer (NMIBC), Muscle-Invasive Bladder Carcinoma
- Being tested
- Sexological Support
- Keywords
- Sexual Health, Bladder Cancer, Sexual Rehabilitation
- Medical subject headings
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexological SupportOther
Results from Study 1a will inform the development and refinement of the intervention to be tested in the feasibility phase (Study 1b).
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm (study 1b) | Experimental | Not described Receives: Other: Sexological Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study 1a: Patient-perceived sexual health challenges identified through semi-structured qualitative interviews
Patient perceptions of sexual health challenges will be explored through semi-structured individual interviews. Interviews will be audio-recorded, transcribed verbatim, and analyzed using thematic analysis. Results will be reported as descriptive themes representing common challenges across participants.
Measured: 1 year
Study 1a: Patient informational needs regarding sexual health identified through semi-structured qualitative interviews
Patient informational needs related to sexual health will be assessed through semi-structured individual interviews. Interview transcripts will be analyzed using thematic analysis, and results will be reported as themes describing shared informational needs.
Measured: 1 year
Study 1a: Patient preferences for professional sexual health support identified through semi-structured qualitative interviews
Patient preferences for professional sexual health support will be explored using semi-structured individual interviews. Data will be analyzed using thematic analysis, and findings will be reported as themes describing preferred type, timing, and format of support.
Measured: 1 year
Study 1b: Recruitment rate
Recruitment rate will be defined as the number of participants enrolled divided by the number of eligible participants approached during the recruitment period.
Measured: 2 years
Study 1b: Retention rate
Retention rate will be defined as the proportion of enrolled participants who complete all required study assessments.
Measured: 2 years
Study 1b: Adherence to study protocol
Protocol adherence will be assessed as the proportion of participants who complete the intervention according to the predefined study procedures.
Measured: 2 years
Study 1b: Response rate to patient-reported outcome measures
Response rate will be defined as the proportion of completed patient-reported outcome questionnaires out of the total number of questionnaires distributed.
Measured: 2 years
Study 1b: Data completeness of patient-reported outcome measures
Data completeness will be assessed as the proportion of fully completed items across all patient-reported outcome measures.
Measured: 2 years
Secondary outcomes (3)
Study 1b: Sexual function assessed by the Female Sexual Function Index (FSFI)
Sexual function will be assessed using the Female Sexual Function Index (FSFI). The total score ranges from 2 to 36, with higher scores indicating better sexual function.
Measured: 2 years
Study 1b: Sexual distress assessed by the Female Sexual Distress Scale-Revised (FSDS-R)
Sexual distress will be measured using the Female Sexual Distress Scale-Revised (FSDS-R). Total scores range from 0 to 52, with higher scores indicating greater sexual distress.
Measured: 2 years
Study 1b: Wellbeing assessed by the WHO-5 Well-Being Index
Wellbeing will be assessed using the WHO-5 Well-Being Index. Scores range from 0 to 100, with higher scores indicating better wellbeing.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Jan 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Not applicable
- Intervention model
- Sequential
- Model description
- * Study 1a (Development phase): A qualitative, exploratory study to develop a sexological intervention with patient and clinician involvement. * Study 1b (Feasibility phase): A one-armed feasibility trial assessing the implementation and acceptability of the intervention among patients with muscle-invasive bladder cancer (MIBC).
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339761
- Sponsor's protocol ID
- DUAUHSPICE
- Acronym
- SPICE
- Status last verified
- Oct 2025
- First submitted
- 10 Dec 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPICE: Supporting Sexual Health in Bladder Cancer Patients: A Sequential Mixed-Methods Intervention Study
- ClinicalTrials.gov ID
- NCT07339761
- Acronym / sponsor ID
- SPICE / DUAUHSPICE
- Conditions
- Bladder Cancer, Non-Muscle-Invasive Bladder Cancer (NMIBC), Muscle-Invasive Bladder Carcinoma
- Keywords
- Sexual Health, Bladder Cancer, Sexual Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 14 Jan 2026 (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.
Despite increasing recognition of sexual dysfunction and sexual distress as important survivorship issues in oncology, research and clinical attention remain uneven across cancer types. This imbalance is particularly evident in bladder cancer, where sexual health has received limited research and clinical attention. However, existing studies demonstrate substantial sexual dysfunction and reduced intimacy among patients following disease and treatment.
The treatment of bladder cancer is a multimodal and multidisciplinary discipline. Low-risk non-muscle-invasive bladder cancer (NMIBC) is treated by transurethral resection of the bladder (TURB) alone, while recurrent intermediate- and high-risk NMIBC undergo a combination of TURB and adjuvant intravesical instillation therapy. For patients with muscle-invasive bladder cancer (MIBC) and specific high-risk NMIBC cases, the first-line treatment option is radical cystectomy with urinary diversion, with or without neoadjuvant chemotherapy.
These treatment modalities are known to have a negative impact on sexual function, and studies in both men and women demonstrate profound impairments in sexual function, intimacy, and body image after treatment. Among men, erectile and ejaculatory dysfunction are prevalent for this patient group and frequently associated with diminished sexual satisfaction and body-image concerns. Likewise, women experience loss of sexual desire, orgasmic disorders, dyspareunia, and vaginal dryness following cystectomy.
A targeted literature search further identified no contemporary sexology-focused interventional or feasibility trials specifically in bladder cancer (neither MIBC or NMIBC). Existing evidence on the topic is largely descriptive or addresses non-sexological rehabilitation, demonstrating a evidence gap[1].
Qualitative research has also explored informational and psychosocial needs among bladder cancer patients, revealing limited communication about sexual health and unmet needs for professional support. Such studies provide valuable insight into patient experiences but have not yet translated this knowledge into the development of structured, sexological interventions.
Evidence from other cancer populations demonstrates that counselling and psychoeducational programmes addressing intimacy and sexuality are both feasible and beneficial, suggesting that similar interventions could be adapted for bladder cancer care.
To develop a relevant and acceptable intervention, it is essential to understand how patients themselves perceive their sexual health challenges, informational needs, and preferences for professional support regarding sexual health.
This project therefore consists of two sequential sub-studies:
- Study 1a (Development phase): A qualitative, exploratory study to develop a sexological intervention with patient and clinician involvement.
- Study 1b (Feasibility phase): A one-armed feasibility trial assessing the implementation and acceptability of the intervention among patients with muscle-invasive bladder cancer (MIBC).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- * Study 1a (Development phase): A qualitative, exploratory study to develop a sexological intervention with patient and clinician involvement. * Study 1b (Feasibility phase): A one-armed feasibility trial assessing the implementation and acceptability of the intervention among patients with muscle-invasive bladder cancer (MIBC).
| Arm | Type | Receives |
|---|---|---|
| Intervention arm (study 1b) | Experimental | Other: Sexological Support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- The participant has one of the following diagnoses and received initial treatment approximately 12 months ago:
- The participant has experienced changes and/or difficulties in sexual function related to the cancer diagnosis and/or its treatment
- The participant speaks and understands Danish
- The participant is aged 18 years or older
- The participant has read and understood the oral and written study information
Key exclusion criteria (4 listed)
- The participant has a history of other cancers located in the pelvic region, including rectal cancer, sarcomas, uterine cancer, cervical cancer, ovarian cancer, prostate cancer, or penile cancer
- The participant has a history of breast cancer
- The participant has a history of other cancers located in the pelvic region, including rectal cancer, sarcomas, uterine cancer, cervical cancer, ovarian cancer, prostate cancer, or penile cancer
- The participant has a history of breast cancer
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 |
|---|---|---|
| Sexological SupportResults from Study 1a will inform the development and refinement of the intervention to be tested in the feasibility phase (Study 1b). | Other | Intervention arm (study 1b) |
Primary outcome
Study 1a: Patient-perceived sexual health challenges identified through semi-structured qualitative interviews
Time frame: 1 year
Patient perceptions of sexual health challenges will be explored through semi-structured individual interviews. Interviews will be audio-recorded, transcribed verbatim, and analyzed using thematic analysis. Results will be reported as descriptive themes representing common challenges across participants.
Study 1a: Patient informational needs regarding sexual health identified through semi-structured qualitative interviews
Time frame: 1 year
Patient informational needs related to sexual health will be assessed through semi-structured individual interviews. Interview transcripts will be analyzed using thematic analysis, and results will be reported as themes describing shared informational needs.
Study 1a: Patient preferences for professional sexual health support identified through semi-structured qualitative interviews
Time frame: 1 year
Patient preferences for professional sexual health support will be explored using semi-structured individual interviews. Data will be analyzed using thematic analysis, and findings will be reported as themes describing preferred type, timing, and format of support.
Study 1b: Recruitment rate
Time frame: 2 years
Recruitment rate will be defined as the number of participants enrolled divided by the number of eligible participants approached during the recruitment period.
Study 1b: Retention rate
Time frame: 2 years
Retention rate will be defined as the proportion of enrolled participants who complete all required study assessments.
Study 1b: Adherence to study protocol
Time frame: 2 years
Protocol adherence will be assessed as the proportion of participants who complete the intervention according to the predefined study procedures.
Study 1b: Response rate to patient-reported outcome measures
Time frame: 2 years
Response rate will be defined as the proportion of completed patient-reported outcome questionnaires out of the total number of questionnaires distributed.
Study 1b: Data completeness of patient-reported outcome measures
Time frame: 2 years
Data completeness will be assessed as the proportion of fully completed items across all patient-reported outcome measures.
3 secondary outcomes
Study 1b: Sexual function assessed by the Female Sexual Function Index (FSFI)
Time frame: 2 years
Study 1b: Sexual distress assessed by the Female Sexual Distress Scale-Revised (FSDS-R)
Time frame: 2 years
Study 1b: Wellbeing assessed by the WHO-5 Well-Being Index
Time frame: 2 years
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 14 Jan 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sexological Support in people with Bladder Cancer and Non-Muscle-Invasive Bladder Cancer (NMIBC), run by University of Aarhus at 1 site in Denmark.
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 14 inclusion and 4 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 14 Jan 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 Denmark. 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 Charlotte Graugaard-Jensen (+45, Charlotte.Graugaard-Jensen@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study 1a: Patient-perceived sexual health challenges identified through semi-structured qualitative interviews (time frame: 1 year). The study lists 8 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 14 Jan 2026.