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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Aarhus

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 is diagnosed with Muscle-invasive bladder cancer treated with cystectomy (removal of the bladder)

The participant speaks and understands Danish

Trial design

Design model

Sequential

Treatments tested in this trial

  • Sexological Support

    Other intervention

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Intervention arm (study 1b)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Study 1a: Patient-perceived sexual health challenges identified through semi-structured qualitative interviews

Patient 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.

Time frame
1 year
2

Study 1a: Patient informational needs regarding sexual health identified through semi-structured qualitative interviews

Patient 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.

Time frame
1 year
3

Study 1a: Patient preferences for professional sexual health support identified through semi-structured qualitative interviews

Patient 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.

Time frame
1 year
4

Study 1b: Recruitment rate

Recruitment rate will be defined as the number of participants enrolled divided by the number of eligible participants approached during the recruitment period.

Time frame
2 years

Secondary outcomes

1

Study 1b: Sexual function assessed by the Female Sexual Function Index (FSFI)

Sexual 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.

Time frame
2 years
2

Study 1b: Sexual distress assessed by the Female Sexual Distress Scale-Revised (FSDS-R)

Sexual 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.

Time frame
2 years
3

Study 1b: Wellbeing assessed by the WHO-5 Well-Being Index

Wellbeing will be assessed using the WHO-5 Well-Being Index. Scores range from 0 to 100, with higher scores indicating better wellbeing.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.