Sexual and Urological Rehabilitation to Men Operated for Prostate Cancer and Their Partners

NCT02103088 | Completed

• 1 other identifier: PROCAN
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

Prostate cancer; Intervention; Rehabilitation; Couple; Sexology; Urology; Late effects

Outcome Measures

Primary Outcomes (1)

• Erectile function measured by the International Index of Erectile Function (IIEF-15)

  To investigate the change in erectile function among patients in intervention- and the control group from baseline to 8 and 12 months follow up and the difference in change between intervention - and the control group

  Baseline, 8 months and 12 months

Secondary Outcomes (8)

• Sexual satisfaction measured by IIEF-15

  Baseline, 8 and 12 months

• Female sexual satisfaction measured by The Female Sexual Function Index (FSFI)

  Baseline, 8 and 12 months

• Female Sexual Distress measured by the Female Sexual Distress Scale (FSDS)

  Baseline, 8 and 12 months

• Urological function measured by The Expanded Prostate Cancer Composite Index (EPIC-26)

  Baseline, 8 and 12 months

• Marital function measured by The Dyadic Adjustment Scale (DAS)

  Baseline, 8 and 12 months

Study Arms (2)

Sexual and urological intervention

EXPERIMENTAL

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.

Behavioral: Sexual and urological intervention

Control

NO INTERVENTION

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.

Interventions

Sexual and urological intervention BEHAVIORAL

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.

Sexual and urological intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Danish Cancer Society: lead
• The Capital Region Research Foundation for Health Research Denmark: collaborator
• Rigshospitalet, Denmark: collaborator
• Clinic for Sexology and Center for Psychiatry Copenhagen Denmark: collaborator

Study Sites (1)

Department of Urology, Rigshospitalet

Copenhagen, Copenhagen Ø, 2100, Denmark

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Sex

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Christoffer Johansen, PhD, Dr. Med

  Danish Cancer Society

  PRINCIPAL INVESTIGATOR

• Randi V. Karlsen, RN, MEd

  Danish Cancer Society

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Dr. Med.Sci, Head of Unit

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 3, 2014
• Study Start: May 1, 2014
• Primary Completion: January 1, 2019
• Study Completion: February 1, 2021
• Last Updated: February 4, 2021

Record last verified: 2021-02

Locations

DK (1)