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

University of Aarhus

Status

Enrolling

Conditions

Bladder Cancer

Muscle-Invasive Bladder Carcinoma

Non-Muscle-Invasive Bladder Cancer (NMIBC)

Treatments

Other: Sexological Support

Study type

Interventional

Funder types

Other

Identifiers

NCT07339761

DUAUHSPICE

Details and patient eligibility

About

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).

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and 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