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NCT07339761Recruiting

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

Source: ClinicalTrials.gov · Last updated 14 Jan 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Interventional
Enrollment
30 (estimated)
First submitted
10 Dec 2025
Start date
1 Jan 2026
Primary completion date
31 Aug 2027
Lead sponsor
University of Aarhus
NCT number
NCT07339761

What you commit to

  • Study type: Interventional
  • Planned participants: 30
  • From 1 Jan 2026 to the primary completion date, 31 Aug 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Who the study is looking for

  • 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
  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Department of Urology, Aarhus University Hospital
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AarhusDenmarkRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.