Clinical trial · Interventional
Sexual and Urological Rehabilitation to Men Operated for Prostate Cancer and Their Partners
PROCAN: Sexual and Urological Rehabilitation to Men Operated for Prostate Cancer and Their Partners: A Randomized Controlled Intervention Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Today prostate cancer (PC) treatment with curative intent is primarily surgical removal of the prostate gland (prostatectomy) which may be associated with immediate and long lasting erectile dysfunction and decline in urinary function. Besides these physical late effects patients operated for PC have a twofold increased risk for depression up to ten years after the diagnosis. To reduce these late effects affecting both patient and partner the investigators have developed a sexual and urological intervention (PROCAN). The intervention is based on epidemiological data, evidence from previous clinical trials, a feasibility study and qualitative explorations among PC patients and partners. The investigators hereby suggest the conduction of a randomized controlled trial to test the effect of the PROCAN intervention on urological and sexual dysfunction, couples adjustment and quality of life. Results of the proposed trial may provide clinicians and decision makers with the evidence needed to optimize rehabilitation after PC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sexual and urological intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sexual and urological intervention
- description
- Standard care and the PROCAN intervention consisting of i) DVD instruction in pelvic floor muscle training ii) group instructions in pelvic floor muscle training by physiotherapist including three individually follow-up and ii) up to six couple sessions performed by a sexual nurse counselor.
- interventionNames
- Behavioral: Sexual and urological intervention
- type
- NO_INTERVENTION
- label
- Control
- description
- Standard care consists of:systematic offer of medical treatment for erectile dysfunction, if not contra indicated. The medical treatment will consist of either daily treatment with Cialis 5 mg or phosphodiesterase type 5 inhibitor on demand before sexual activity. Alternatively use of alprostadil as either urethral pin or penile injection. Furthermore standard treatments include preoperative instruction in pelvic floor muscle training, regular outpatient visits and possible referral to rehabilitation in accordance with the rules that apply to the Danish Health legislations. In case of prolonged incontinence the patients may on request be referred to a private practicing physiotherapist.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: Patients operated for primary prostate cancer with open or robot-assisted surgery using nerve sparring or non-nerve sparring technique living with a female partner and reported being sexually active before the operation. Exclusion Criteria:Patients with other cancers (except non-melanoma skin cancer) within 5 years, major psychiatric disorder, abuse of alcohol or drugs, dementia, e.g. Alzheimer's disease and patients, who do not understand or speak Danish. Patients, who reported not being sexually active before the operation and partners who do not understand or speak Danish.
References
Publications (0)
Data not yet available