Cosmetic Appeal, HRQoL and Effectiveness of Simple and Pseudotesticular Techniques of Orchidectomy in Prostate Cancer (TEPSO)

Comparison of the Therapeutic Efficacy and Patient Satisfaction of Three Techniques of Bilateral Orchidectomy in Prostate Cancer Patients of a Nigerian Sub-population (TEPSO)

The therapeutic efficacy of three types of orchidectomy was ascertained as well as the QoL and scrotal cosmetic satisfaction of patients in the three surgical arms. Two of these surgeries produced a pseudotesticle (BSCO, BESO) while one (BSO) did not.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Prostate Cancer; Orchiectomy
• Intervention / Treatment: Procedure: Bilateral simple orchidectomy (BSO); Procedure: Bilateral Subcapsular Orchidectomy; Procedure: Bilateral Epididymal-sparing Orchidectomy

Detailed Description

Patients with prostate cancer (PCa) were grouped into three surgical arms: BSO (bilateral simple orchidectomy), BSCO (bilateral subcapsular orchidectomy) and BESO (bilateral epididymal-sparing orchidectomy). Preoperatively, baseline serum testosterone, PSA, Quality of life (QoL) and pre-operative testicular volumes were obtained. Timed interval sampling for serum testosterone and PSA variation was done post-operatively. By three months post-op, the cosmetic appeal of the scrotal appearance, post-operative pseudotesticular volumes and QoL were also assessed.

The therapeutic efficacy of the surgeries was determined by the rates of decline of serum testosterone and PSA, as well as the nadirs achieved. The variations in the pre-and post-operative QoL was analysed.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nigeria
  • Oyo
    • Ibadan, Oyo, Nigeria, 200212
      • University College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Consecutive consenting patients with histologically confirmed locally advanced or metastatic PCa who have accepted to have an orchidectomy

Exclusion Criteria:

• Patients who have had bilateral orchidectomy
• Those who opt for medical castration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bilateral simple orchidectomy (BSO); The patients would have the testis, epididymis and distal cord structures excised	Procedure: Bilateral simple orchidectomy (BSO)
Experimental: Subcapsular orchidectomy (BSCO); The tunica albuginea was incised longitudinally and the testicular parenchyma scraped off it. The hilar region was secured with a haemostat and the parenchyma excised off it. A haemostatic suture was applied at the hilum. A running interlocking water-tight capsular suture was inserted	Procedure: Bilateral Subcapsular Orchidectomy
Experimental: Epididymal-sparing orchidectomy (BESO); The epididymal sinus was developed. The epididymal vessels were sequentially clamped and divided, removing the testicle from the epididymis. The caput was looped to meet the head and the adjoining surfaces of the body sutured together (epididymoplasty) Vasectomy done to reduce future risk of epididymitis	Procedure: Bilateral Epididymal-sparing Orchidectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Summative and domain quality of life scores	Expanded Prostate Cancer Index Composite- 26 questionnaires were also used to assess various aspects of the QoL pre-and post-operatively. EPIC 26 scores are ranked from 0 to 100 with higher scores indicating better function and less bother. Urinary incontinence, Lower Urinary Tract Symptoms, Bowel function/bother, Sexual function/bother, Hormone and vitality were assessed.	Three months
Summative and domain quality of life scores	Life Satisfaction -8 questionnaire was used to complement the EPIC-26 in the QoLassessment pre-and post-operatively. Lisat-8 is ranked from 1 to 6, with 5 and 6 denoting satisfaction (5: Satisfying; 6: Satisfying) while scores of 4 and below connote varied degrees of dissatisfaction (1: very dissatisfying; 2: Dissatisfying; 3: Rather dissatisfying; 4: Rather satisfying) EPIC 26 scores are ranked from 0 to 100 with higher scores indicating better function and less bother. Urinary incontinence, Lower Urinary Tract Symptoms, Bowel function/bother, Sexual function/bother, Hormone and vitality were assessed.	Three months
Change in pseudotesticular volume	A Prader orchidometer was used to measure the pre-operative testicular volume and post-operative pseudotesticular volume in cm3	Three months
Satisfaction with scrotal appearance	Patient rating of cosmetic appeal of the scrotum using a graduated Visual Analog Scale rated between 0 and 100 to signify a score of 0 to 100%. Higher values indicated better satisfaction with scrotal appearance	three months after the orchidectomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum PSA levels	The serum PSA levels in ng/ml were measured pre-operatively, at removal of the testes, hourly for the first three hours, at seven days and three months post-operatively. Percentage PSA declines, PSA nadirs (ng/ml) and time to the attainment of PSA nadirs (hours) were determined from the data obtained.	Three months (timed interval sampling)
Serum testosterone levels	The serum testosterone levels in nmol/l were measured pre-operatively, at removal of the testes, hourly for the first three hours, at seven days and three months post-operatively. The attainment of surgical castrate levels of 20nmol/l or medical castrate levels of 20 nmol/l or medical castrate levels of 50nmol/l was assessed for as well as the testosterone nadirs achieved (nmol/l) and time to the attainment of testosterone nadirs (hours).	Three months (timed interval sampling)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Socioeconomic standing of the patients	The EPIC 2.2002 questionnaire was used to determine the relationship, occupational, educational and financial statuses of the patients	Snap-shot assessment at enrolment

Collaborators and Investigators

• Sponsor: University College Hospital, Ibadan
• Investigators: Principal Investigator: Ijeoma NC Chibuzo, MBBS, MSc, University College Hospital, Ibadan

Publications and helpful links

General Publications

• Chibuzo INC, Takure AO, Shittu OB, Okeke LI,
• Chibuzo INC, Takure AO, Shittu OB, Okeke LI. Cosmetic Appeal, HRQoL, and Effectiveness of Simple and Pseudotesticular Techniques of Orchidectomy in Prostate Cancer. Prostate Cancer. 2021 Nov 26;2021:9968570. doi: 10.1155/2021/9968570. eCollection 2021.

Helpful Links

• Article publication on simple and pseudotesticular techniques of orchidectomy

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2016
• Primary Completion (Actual): February 26, 2018
• Study Completion (Actual): February 26, 2018

Study Registration Dates

• First Submitted: July 30, 2018
• First Submitted That Met QC Criteria: November 13, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: orchidectomy; pseudotesticle
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 15/0424

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No