Sexual health support after bladder cancer treatment
SPICE: Supporting Sexual Health in Bladder Cancer Patients: A Sequential Mixed-Methods Intervention Study
This project will try sexological support to help adults about 12 months after bladder cancer treatment improve sexual function and intimacy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT07339761 on ClinicalTrials.gov |
What this trial studies
This interventional, sequential mixed‑methods project offers sexological support to adults treated for non‑muscle‑invasive or muscle‑invasive bladder cancer about a year earlier. Participants include people treated with transurethral resection (with or without intravesical therapy) and those who have undergone cystectomy. The study combines quantitative outcome measures of sexual function and distress with qualitative interviews to refine the intervention and understand participants' experiences. Recruitment and intervention take place at the Department of Urology, Aarhus University Hospital, and all activities are conducted in Danish.
Who should consider this trial
Good fit: Adults (18+) who speak Danish, were treated for NMIBC or MIBC roughly 12 months ago, and are experiencing cancer- or treatment-related changes in sexual function are the intended participants.
Not a fit: People without cancer-related sexual problems, those with prior other pelvic cancers (who are excluded), non‑Danish speakers, or those unable to attend the Aarhus site are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the intervention could reduce sexual dysfunction and distress and improve intimacy and overall quality of life for bladder cancer survivors.
How similar studies have performed: Sexual rehabilitation and counseling have shown benefit in other cancer groups, but dedicated interventions for bladder cancer are limited, so this approach is partly evidence-based but relatively novel for this population.
Eligibility criteria
Show full inclusion / exclusion criteria
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 Exclusion Criteria study 1b: * 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
Where this trial is running
Aarhus
- Department of Urology, Aarhus University Hospital — Aarhus, Denmark (Recruiting)
Study contacts
- Study coordinator: Charlotte Graugaard-Jensen
- Email: Charlotte.Graugaard-Jensen@rm.dk
- Phone: +45
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.