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

January 5, 2026 updated by: University of Aarhus

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Recruiting
        • Department of Urology, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm (study 1b)
Other: Sexological Support
Results from Study 1a will inform the development and refinement of the intervention to be tested in the feasibility phase (Study 1b).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study 1a: Patient-perceived sexual health challenges identified through semi-structured qualitative interviews
Time Frame: 1 year
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.
1 year
Study 1a: Patient informational needs regarding sexual health identified through semi-structured qualitative interviews
Time Frame: 1 year
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.
1 year
Study 1a: Patient preferences for professional sexual health support identified through semi-structured qualitative interviews
Time Frame: 1 year
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.
1 year
Study 1b: Recruitment rate
Time Frame: 2 years
Recruitment rate will be defined as the number of participants enrolled divided by the number of eligible participants approached during the recruitment period.
2 years
Study 1b: Retention rate
Time Frame: 2 years
Retention rate will be defined as the proportion of enrolled participants who complete all required study assessments.
2 years
Study 1b: Adherence to study protocol
Time Frame: 2 years
Protocol adherence will be assessed as the proportion of participants who complete the intervention according to the predefined study procedures.
2 years
Study 1b: Response rate to patient-reported outcome measures
Time Frame: 2 years
Response rate will be defined as the proportion of completed patient-reported outcome questionnaires out of the total number of questionnaires distributed.
2 years
Study 1b: Data completeness of patient-reported outcome measures
Time Frame: 2 years
Data completeness will be assessed as the proportion of fully completed items across all patient-reported outcome measures.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study 1b: Sexual function assessed by the Female Sexual Function Index (FSFI)
Time Frame: 2 years
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.
2 years
Study 1b: Sexual distress assessed by the Female Sexual Distress Scale-Revised (FSDS-R)
Time Frame: 2 years
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.
2 years
Study 1b: Wellbeing assessed by the WHO-5 Well-Being Index
Time Frame: 2 years
Wellbeing will be assessed using the WHO-5 Well-Being Index. Scores range from 0 to 100, with higher scores indicating better wellbeing.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DUAUHSPICE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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