Sexual and Urological Rehabilitation to Men Operated for Prostate Cancer and Their Partners
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      Although the potential negative impact of prostate cancer on sexual and urological function
      is well documented there is no evidence based and standardized rehabilitation offer available
      for Danish couples affected by prostate cancer. This study proposal is based on a thorough
      literature review on PC treatment and late effects and interventions targeting sexual and
      urological late effects and a qualitative study including interviews with 6 couples affected
      by PC. The literature review showed that; medical treatment is effective for the treatment of
      erectile dysfunction, psychosocial intervention may ease sexual problems secondary to
      operation for prostate cancer and sexual counseling may improve compliance with medical
      treatment of erectile dysfunction. In regard to treatment of urological dysfunction studies
      showed that the effect of pelvic floor muscle training is enhanced by follow-up instructions
      by physiotherapist. Our interview study among patients operated for prostate cancer and their
      partners indicated a general need and demand for professional help to discuss the changed
      sexual life. Also studies have shown that health professionals find it difficult to discuss
      sexual problems with the patients. Medical treatment for erectile dysfunction is prescribed
      to patients operated for prostate cancer, however the treatment is not offered systematically
      in all hospitals and furthermore the drugs are sold on the internet.In view of this knowledge
      we determine that there is a need for studies which include patients systematically offered
      medical treatment for erectile dysfunction and further is offered sexual counseling and thus
      focusing on: i) treatment of physical, psychological and social aspects of sexual dysfunction
      ii) improvement of compliance with the medical treatment for erectile dysfunction and iii)
      reducing barriers among patients and health professionals for resolving sexual problems
      secondary to operation for prostate cancer.

      The purpose of the PROCAN study is in a randomized design to test the effect of a theory
      based intervention on sexual and urological dysfunctions secondary to operation for prostate
      cancer. The PROCAN intervention consists of: i) Digital Video Disc (DVD) instruction in
      pelvic floor muscle training ii) group instructions in pelvic floor muscle training by
      physiotherapist including up to three individually follow-up and ii) up to six couple
      sessions performed by a sexual nurse counselor. The intervention is based on social and
      cognitive behavioral techniques and techniques derived from sexual therapy and counseling
      with a psycho-educational approach, in which sexuality is defined as a multidimensional
      construct involving biological, psychological and social aspects. The intervention is
      documented and developed in collaboration with urologists, physiotherapists and sexologists.
      The investigators will enroll patients and partners from the Urological Department
      Rigshospitalet and randomize 160 couples. Patients and partners will be randomized (1:1) to
      standard care plus the PROCAN intervention and to standard care (control Group). The
      investigators hypothesize that the PROCAN intervention will:

        -  Improve urological and sexual functioning among prostate cancer patients and sexual
           function and satisfaction among patients and female partners

        -  Improve the dyadic adjustment and the overall quality of life in prostate cancer
           patients and their partners

        -  Reduce the prevalence of depression and anxiety in patients and their partners
    

Intervention name(s): Sexual and urological intervention
Intervention type(s): Behavioral
Intervention description(s): Sexual and urological 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Prostate cancer; Intervention; Rehabilitation; Couple; Sexology; Urology; Late effects