Evaluation of Botox Treatment on Chronical Scrotal Pain

NCT05112081 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: E-BTX-CSP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the effect of botox injections at the spermatic cord in patients with chronical scrotal pain. A lot of patients experiences depressive symptoms and a lot feel isolated. The etiology if not fully understood and the condition poses a challenge for physicians. The is no efficient minimal invasive treatment for these patients, and in severe cases patients are having there testicle removed. By inject botox around the spermatic cord the investigators hope to relieve some of the pain in these patients and offer patients a new minimal invasive treatment. The investigators aim to include 50 patients in this study, There will be randomised 1:1 to either the intervention arm (Botox) or control arm (sterile saline). Both patients and physicians will be blinded to the treatment. Patients will undergo a thorough physical examination and will be asked to fill out questionaries to asses their quality of life. After inclusion, patients will be followed closely for three months with physical examination and questionnaires. After three months, patients in the control arm will have the opportunity to cross over to the intervention arm. Data will be reported continuously.

Conditions

Scrotum Disease; Chronic Pain

Keywords

Chronical scrotal pain; CSP; Botox; BTX; minimal invasive procedure

Outcome Measures

Primary Outcomes (1)

• Effect on pain 3 months after treatment

  Pain is evaluated on a Visual Analog Scale (VAS) from 0-10, where 0 is no pain and 10 is the maximal pain a patient can report. VAS prior to the treatment is compared to VAS 3 months after treatment.

  3 months

Secondary Outcomes (6)

• Duration of effect

  3 months

• Changes in patient reported Quality of Life

  3 months

• Changes in patient reported Quality of Life

  3 months

• Changes in patient reported Quality of Life

  3 months

• Changes in patient reported Quality of Life

  3 months

Study Arms (2)

Botox injections

EXPERIMENTAL

Patients randomised to the intervention arm will be treated with injection of 100 units of botox in 10 ml sterile saline close to superficial inguinal ring.

Drug: Botulinum toxin type A

Sterile saline injections

PLACEBO COMPARATOR

Patients randomised to the control arm will be treated with injection of 10 ml sterile saline close to superficial inguinal ring.

Other: Sterile saline

Interventions

Botulinum toxin type A DRUG

The group will receive a solution of 100 units BTX with 10 ml sterile saline close to the superficial inguinal ring.

Botox injections

Sterile saline OTHER

The group will receive a solution of 10 ml sterile saline close to the superficial inguinal ring.

Sterile saline injections

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18 - 70 years
• Unilateral or bilateral scrotal pain \> 3 months
• No other identifiable cause of pain
• Insufficient effect of conservative treatment
• A positive effect of local anesthesia spermatic cord block

You may not qualify if:

• Inability to provide informed consent
• Interest in trying to conceive with partner in the following 6 months
• Local infection near the proposed injection site
• History with an allergic reaction to BTX and / or human serum albumin
• History of motor neuron disease or hemostatic disorder
• Active urogenital cancer
• Current use of botox injections which would result in a total dose of botox higher than 300 IE in the span of 3 months

Sponsors & Collaborators

• Nicolai Skov Schiellerup: lead

Study Sites (1)

Odense University Hospital

Odense C, Fyn, 5000, Denmark

Location

Related Publications (22)

• Sigalos JT, Pastuszak AW. Chronic orchialgia: epidemiology, diagnosis and evaluation. Transl Androl Urol. 2017 May;6(Suppl 1):S37-S43. doi: 10.21037/tau.2017.05.23.

  PMID: 28725616 BACKGROUND

• Schover LR. Psychological factors in men with genital pain. Cleve Clin J Med. 1990 Nov-Dec;57(8):697-700. doi: 10.3949/ccjm.57.8.697.

  PMID: 2257677 BACKGROUND

• Aljumaily A, Forbes E, Al-Khazraji HAJ, Gordon A, Lau S, Jarvi KA. Frequency and severity of chronic scrotal pain in Canadian men presenting to urologists for infertility investigations. Transl Androl Urol. 2017 Dec;6(6):1150-1154. doi: 10.21037/tau.2017.11.28.

  PMID: 29354503 BACKGROUND

• Singh V, Sinha RJ. Idiopathic chronic orchialgia - a frustrating issue for the clinician and the patient. Indian J Surg. 2008 Jun;70(3):107-10. doi: 10.1007/s12262-008-0032-x. Epub 2008 Jul 24.

  PMID: 23133036 BACKGROUND

• Wu C, Jarvi K. Management of chronic scrotal content pain. Can Urol Assoc J. 2018 Jun;12(6 Suppl 3):S164-S166. doi: 10.5489/cuaj.5326. No abstract available.

  PMID: 29875043 BACKGROUND

• Calixte N, Brahmbhatt J, Parekattil S. Genital pain: algorithm for management. Transl Androl Urol. 2017 Apr;6(2):252-257. doi: 10.21037/tau.2017.03.03.

  PMID: 28540232 BACKGROUND

• Jarvi KA, Wu C, Nickel JC, Domes T, Grantmyre J, Zini A. Canadian Urological Association best practice report on chronic scrotal pain. Can Urol Assoc J. 2018 Jun;12(6):161-172. doi: 10.5489/cuaj.5238. Epub 2018 Feb 23. No abstract available.

  PMID: 29485040 BACKGROUND

• Benson JS, Abern MR, Larsen S, Levine LA. Does a positive response to spermatic cord block predict response to microdenervation of the spermatic cord for chronic scrotal content pain? J Sex Med. 2013 Mar;10(3):876-82. doi: 10.1111/j.1743-6109.2012.02937.x. Epub 2012 Sep 27.

  PMID: 23016953 BACKGROUND

• Kumar R. Therapeutic use of botulinum toxin in pain treatment. Neuronal Signal. 2018 Aug 31;2(3):NS20180058. doi: 10.1042/NS20180058. eCollection 2018 Sep.

  PMID: 32714587 BACKGROUND

• Sim WS. Application of botulinum toxin in pain management. Korean J Pain. 2011 Mar;24(1):1-6. doi: 10.3344/kjp.2011.24.1.1. Epub 2011 Feb 25.

  PMID: 21390172 BACKGROUND

• Colhado OC, Boeing M, Ortega LB. Botulinum toxin in pain treatment. Rev Bras Anestesiol. 2009 May-Jun;59(3):366-81. doi: 10.1590/s0034-70942009000300013. English, Portuguese.

  PMID: 19488551 BACKGROUND

• Soares A, Andriolo RB, Atallah AN, da Silva EM. Botulinum toxin for myofascial pain syndromes in adults. Cochrane Database Syst Rev. 2014 Jul 25;2014(7):CD007533. doi: 10.1002/14651858.CD007533.pub3.

  PMID: 25062018 BACKGROUND

• Moore C, Rackley R, Goldman H. Urologic applications of botox. Curr Urol Rep. 2005 Nov;6(6):419-23. doi: 10.1007/s11934-005-0035-0.

  PMID: 16238914 BACKGROUND

• Aoki KR. Evidence for antinociceptive activity of botulinum toxin type A in pain management. Headache. 2003 Jul-Aug;43 Suppl 1:S9-15. doi: 10.1046/j.1526-4610.43.7s.3.x.

  PMID: 12887389 BACKGROUND

• Nigam PK, Nigam A. Botulinum toxin. Indian J Dermatol. 2010;55(1):8-14. doi: 10.4103/0019-5154.60343.

  PMID: 20418969 BACKGROUND

• Chancellor MB, Fowler CJ, Apostolidis A, de Groat WC, Smith CP, Somogyi GT, Aoki KR. Drug Insight: biological effects of botulinum toxin A in the lower urinary tract. Nat Clin Pract Urol. 2008 Jun;5(6):319-28. doi: 10.1038/ncpuro1124. Epub 2008 May 6.

  PMID: 18461049 BACKGROUND

• Khambati A, Lau S, Gordon A, Jarvi KA. OnabotulinumtoxinA (Botox) nerve blocks provide durable pain relief for men with chronic scrotal pain: a pilot open-label trial. J Sex Med. 2014 Dec;11(12):3072-7. doi: 10.1111/jsm.12707. Epub 2014 Oct 6.

  PMID: 25284738 BACKGROUND

• Dockray J, Aljumaily A, Lau S, Jarvi KA. A Randomized, Double-Blind, Controlled Trial Shows that Onabotulinum Toxin A Nerve Blocks do Not Provide Improved Pain Control in Men with Chronic Scrotal Pain. J Urol. 2020 Apr;203(4):767-772. doi: 10.1097/JU.0000000000000658. Epub 2019 Oct 18.

  PMID: 31738115 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• Heidenreich A, Olbert P, Engelmann UH. Management of chronic testalgia by microsurgical testicular denervation. Eur Urol. 2002 Apr;41(4):392-7. doi: 10.1016/s0302-2838(02)00023-4.

  PMID: 12074809 BACKGROUND

• Park J, Park HJ. Botulinum Toxin for the Treatment of Neuropathic Pain. Toxins (Basel). 2017 Aug 24;9(9):260. doi: 10.3390/toxins9090260.

  PMID: 28837075 BACKGROUND

• Lee CL, Kuo HC. Long-Term Efficacy and Safety of Repeated Intravescial OnabotulinumtoxinA Injections Plus Hydrodistention in the Treatment of Interstitial Cystitis/Bladder Pain Syndrome. Toxins (Basel). 2015 Oct 22;7(10):4283-93. doi: 10.3390/toxins7104283.

  PMID: 26506388 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Mads H Poulsen, MD, PhD

  Assistant professor

  STUDY DIRECTOR

Central Study Contacts

Nicolai S Schiellerup, MD

CONTACT

+45 61692160; Nicolai.Skov.Schiellerup@rsyd.dk

Hanne Kobberø, MD

CONTACT

Hanne.Kobberoe2@rsyd.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: For randomization the research coordinator will place an information sheet containing the randomization in sealed envelopes (1:1 block randomization). At first treatment the research coordinator will open a sealed envelope revealing the randomization and prepare the solution needed. The patient and physician will be blinded for the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: This study is a prospective, randomized, placebo-controlled, double-blinded multi-center trial. Patients are included from the whole region of Southern Denmark. In case of successful spermatic cord block patients will be randomized to either BTX cord block or injection with sterile saline. Patients will be followed up according to the questionnaires. After three months, patients in the control arm will have the option to cross-over to the intervention arm.

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: November 8, 2021
• Study Start: June 1, 2022
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Will be available when patient enrolment starts and as long as the study is active.
• Access Criteria: The protocol will be available to the public.

Locations

DK (1)