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Supporting Sexual Health in Bladder Cancer Patients: A Sequential Mixed-Methods Intervention Study

SPICE: Supporting Sexual Health in Bladder Cancer Patients: A Sequential Mixed-Methods Intervention Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07339761
Acronym
SPICE
Enrollment
30
Registered
2026-01-14
Start date
2026-01-01
Completion date
2028-08-31
Last updated
2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer, Muscle-Invasive Bladder Carcinoma, Non-Muscle-Invasive Bladder Cancer (NMIBC)

Keywords

Sexual Health, Bladder Cancer, Sexual Rehabilitation

Brief 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. 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).

Interventions

OTHERSexological Support

Results from Study 1a will inform the development and refinement of the intervention to be tested in the feasibility phase (Study 1b).

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention 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).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

study 1a: * The participant has one of the following diagnoses and received initial treatment approximately 12 months ago: 1. Non-muscle-invasive bladder cancer treated with transurethral resection of the bladder (TUR-B) 2. Non-muscle-invasive bladder cancer treated with TUR-B and subsequent intravesical instillation therapy with chemotherapy or immunotherapy 3. 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 * 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

Exclusion criteria

study 1a: * 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 Inclusion Criteria study 1b: * 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

Design outcomes

Primary

MeasureTime frameDescription
Study 1b: Data completeness of patient-reported outcome measures2 yearsData completeness will be assessed as the proportion of fully completed items across all patient-reported outcome measures.
Study 1b: Retention rate2 yearsRetention rate will be defined as the proportion of enrolled participants who complete all required study assessments.
Study 1b: Adherence to study protocol2 yearsProtocol 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 measures2 yearsResponse rate will be defined as the proportion of completed patient-reported outcome questionnaires out of the total number of questionnaires distributed.
Study 1a: Patient-perceived sexual health challenges identified through semi-structured qualitative interviews1 yearPatient 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 interviews1 yearPatient 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 interviews1 yearPatient 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 rate2 yearsRecruitment rate will be defined as the number of participants enrolled divided by the number of eligible participants approached during the recruitment period.

Secondary

MeasureTime frameDescription
Study 1b: Sexual distress assessed by the Female Sexual Distress Scale-Revised (FSDS-R)2 yearsSexual 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.
Study 1b: Wellbeing assessed by the WHO-5 Well-Being Index2 yearsWellbeing will be assessed using the WHO-5 Well-Being Index. Scores range from 0 to 100, with higher scores indicating better wellbeing.
Study 1b: Sexual function assessed by the Female Sexual Function Index (FSFI)2 yearsSexual 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.

Countries

Denmark

Contacts

Primary ContactCharlotte Graugaard-Jensen
Charlotte.Graugaard-Jensen@rm.dk+45

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026