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

NCT ID: NCT07339761

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2028-08-31

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).

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention arm (study 1b)

Group Type: EXPERIMENTAL

Sexological Support

Intervention Type: OTHER

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

Interventions

Sexological Support

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Urology, Aarhus University Hospital

Aarhus, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Charlotte Graugaard-Jensen

Role: CONTACT

Charlotte.Graugaard-Jensen@rm.dk

+45

Other Identifiers

DUAUHSPICE

Identifier Type: -

Identifier Source: org_study_id