Dorsal Penile Nerve Block for Rigid Cystoscopy in Men

• Sponsor: West China Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02502487
• Collaborator: (none)
• Enrollment: 258
• Location: 1
• Arms: 3
• Duration (Months): 9
• Patients Per Site Per Month: 28.7

Study Details

Study Description

Brief Summary

This study will determine the effectiveness and safety of dorsal penile nerve block (DPNB) in men undergoing rigid cystoscopy.

Condition or Disease	Intervention/Treatment	Phase
Pain	Procedure: Dorsal Penile Nerve Block; Drug: Ropivacaine; Drug: Tetracaine	N/A

Detailed Description

Pain is common in men undergoing rigid cystoscopy. Even with application of a lubricant containing 2% lidocaine, about 76% men suffer from mild to severe pain when undergoing rigid cystoscopy, and approximately 27% men could still feel mild to moderate pain 7 days after the procedure. The most painful part of the procedure for men is when the cystoscope passes through the membranous urethra. Song et al did autopsy on males found dorsal nerve of the penis (DNP), the terminal branch of the pudendal nerve, innervates the membranous urethra in 53.3% specimens. In addition, urethral mucosa has branches of DNP innervated. Dorsal penile nerve block (DPNB) is usually used for circumcision in children and it has been shown to provide effective analgesia for penile surgeries. According to the evidence that some DNP branches innervate membranous urethra and urethra mucosa and most pain originates from cystoscope passing through membranous urethra, we speculated that DPNB could overall reduce pain level in men during rigid cystoscopy.

Study Design

• Study Type: Interventional
• Actual Enrollment: 258 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Dorsal Penile Nerve Block for Rigid Cystoscopy in Men: a Single-center, Randomized, Double-blind and Placebo-controlled Study
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Tetracaine gel group Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy	Drug: Tetracaine; 1% Tetracaine gel instilled into urethra
Experimental: Dorsal penile nerve block group Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy	Procedure: Dorsal Penile Nerve Block; Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis; Drug: Ropivacaine; 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
Experimental: Combination group Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy	Procedure: Dorsal Penile Nerve Block; Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis; Drug: Ropivacaine; 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis; Drug: Tetracaine; 1% Tetracaine gel instilled into urethra

Outcome Measures

Primary Outcome Measures

1. Visual Analog Scale (VAS) for Pain [at cystoscopic inspection of external sphincter]

   A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients' pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.

Secondary Outcome Measures

1. Visual Analog Scale (VAS) for Pain [before gel administration]

   A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients' pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.

2. Visual Analog Scale (VAS) for Pain [at cystoscopic inspection of penile and bulbar urethra]

   A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients' pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.

3. Visual Analog Scale (VAS) for Pain [at cystoscopic inspection of prostate and bladder]

   A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients' pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.

4. Visual Analog Scale (VAS) for Pain [after withdrawal of cystoscope]

   A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients' pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.

5. Heart Rate Before Gel Administration [before gel administration]

6. Heart Rate at Cystoscopic Inspection of Penile and Bulbar Urthra [at cystoscopic inspection of penile and bulbar urethra]

7. Heart Rate at Cystoscopic Inspection of External Sphincter [at cystoscopic inspection of external sphincter]

8. Heart Rate After Withdrawal of Cystoscope [after withdrawal of cystoscope]

9. Mean Arterial Pressure Before Gel Administration [before gel administration]

10. Mean Arterial Pressure at Cystoscopic Inspection of Penile and Bulbar Urthra [at cystoscopic inspection of penile and bulbar urthra]

11. Mean Arterial Pressure at Cystoscopic Inspection of External Sphincter [at cystoscopic inspection of external sphincter]

12. Mean Arterial Pressure After Withdrawal of Cystoscope [after withdrawal of cystoscope]

13. Oxygen Saturation by Pulse Before Gel Administration [before gel administration]

14. Oxygen Saturation by Pulse at Cystoscopic Inspection of Penile and Bulbar Urthra [at cystoscopic inspection of penile and bulbar urthra]

15. Oxygen Saturation by Pulse at Cystoscopic Inspection of External Sphincter [at cystoscopic inspection of external sphincter]

16. Oxygen Saturation by Pulse After Withdrawal of Cystoscope [after withdrawal of cystoscope]

17. Breath Rate Before Gel Administration [before gel administration]

18. Breath Rate at Cystoscopic Inspection of Penile and Bulbar Urthra [at cystoscopic inspection of penile and bulbar Urthra]

19. Breath Rate at Cystoscopic Inspection of External Sphincter [at cystoscopic inspection of external sphincter]

20. Breath Rate After Withdrawal of Cystoscope [after withdrawal of cystoscope]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) Physical Status I-II

• Without history of urethral or prostatic surgery

• Without respiration or circulation disorders

• Without chronic pain

Exclusion Criteria:

• Allergy to local anesthetics

• Coagulation disorder or usage of antiplatelet drugs

• Infection at the site of puncture point

• Severe urethral stenosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West China Hospital of Sichuan University, Department of Anesthesiology	Chengdu	Sichuan	China	610041

Sponsors and Collaborators

• West China Hospital

Investigators

• Principal Investigator: Guizhi Du, Doctor, West China Hospital of Sichuan University, Department of Anesthesiology

Study Documents (Full-Text)

None provided.

More Information

Publications

• Babjuk M, Burger M, Zigeuner R, Shariat SF, van Rhijn BW, Compérat E, Sylvester RJ, Kaasinen E, Böhle A, Palou Redorta J, Rouprêt M; European Association of Urology. EAU guidelines on non-muscle-invasive urothelial carcinoma of the bladder: update 2013. Eur Urol. 2013 Oct;64(4):639-53. doi: 10.1016/j.eururo.2013.06.003. Epub 2013 Jun 12. Review.
• Goldfischer ER, Cromie WJ, Karrison TG, Naszkiewicz L, Gerber GS. Randomized, prospective, double-blind study of the effects on pain perception of lidocaine jelly versus plain lubricant during outpatient rigid cystoscopy. J Urol. 1997 Jan;157(1):90-4.
• Kirya C, Werthmann MW Jr. Neonatal circumcision and penile dorsal nerve block--a painless procedure. J Pediatr. 1978 Jun;92(6):998-1000.
• Kozacioglu Z, Kiray A, Ergur I, Zeybek G, Degirmenci T, Gunlusoy B. Anatomy of the dorsal nerve of the penis, clinical implications. Urology. 2014 Jan;83(1):121-4. doi: 10.1016/j.urology.2013.07.075. Epub 2013 Nov 12.
• Ramsey EW, Elhilali M, Goldenberg SL, Nickel CJ, Norman R, Perreault JP, Piercy B, Trachtenberg J. Practice patterns of Canadian urologists in benign prostatic hyperplasia and prostate cancer. Canadian Prostate Health Council. J Urol. 2000 Feb;163(2):499-502.
• Seklehner S, Remzi M, Fajkovic H, Saratlija-Novakovic Z, Skopek M, Resch I, Duvnjak M, Hruby S, Librenjak D, Hübner W, Breinl E, Riedl C, Engelhardt PF. Prospective multi-institutional study analyzing pain perception of flexible and rigid cystoscopy in men. Urology. 2015 Apr;85(4):737-41. doi: 10.1016/j.urology.2015.01.007.
• Song LJ, Lu HK, Wang JP, Xu YM. Cadaveric study of nerves supplying the membranous urethra. Neurourol Urodyn. 2010 Apr;29(4):592-5. doi: 10.1002/nau.20768.
• Taghizadeh AK, El Madani A, Gard PR, Li CY, Thomas PJ, Denyer SP. When does it hurt? Pain during flexible cystoscopy in men. Urol Int. 2006;76(4):301-3.

• Responsible Party: Yan Qiu, Attending Physician, West China Hospital
• ClinicalTrials.gov Identifier: NCT02502487
• Other Study ID Numbers: WestChinaHAesthesia-1
• First Posted: Jul 20, 2015
• Last Update Posted: Mar 31, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Yan Qiu, Attending Physician, West China Hospital: Analgesia; Cystoscopy; Dorsal nerve of penis; Nerve block; Ropivacaine
• Additional relevant MeSH terms: Ropivacaine; Tetracaine

Study Results

Participant Flow

Arm/Group Title	Tetracaine Gel Group	Dorsal Penile Nerve Block Group	Combination Group
Arm/Group Description	Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy Tetracaine: 1% Tetracaine gel instilled into urethra	Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis	Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis Tetracaine: 1% Tetracaine gel instilled into urethra
Period Title: Overall Study
STARTED	86	86	86
COMPLETED	86	86	86
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Tetracaine Gel Group	Dorsal Penile Nerve Block Group	Combination Group	Total
Arm/Group Description	Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy Tetracaine: 1% Tetracaine gel instilled into urethra	Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis	Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis Tetracaine: 1% Tetracaine gel instilled into urethra	Total of all reporting groups
Overall Participants	86	86	86	258
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.4 (11.5)	52.1 (13.0)	53.5 (12.0)	53.0 (12.2)
Sex/Gender, Customized (participants) [Number]
Male	86 100%	86 100%	86 100%	258 100%
Body weight (Kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kg]	66.8 (8.2)	68.8 (9.6)	66.4 (8.9)	67.3 (8.9)
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	167.3 (5.6)	168.7 (5.5)	167.8 (6.4)	167.9 (5.8)
Body mass index (Kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kg/m^2]	23.8 (2.4)	24.2 (3.0)	23.6 (2.7)	23.8 (2.7)
Duration of cystoscopy (min) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [min]	3.5 (0.6)	3.5 (0.5)	3.4 (0.5)	3.5 (0.6)
Cystoscopy history (participants) [Number]
First-time cystoscopy	60 69.8%	58 67.4%	61 70.9%	179 69.4%
Repeat cystoscopy	26 30.2%	28 32.6%	25 29.1%	79 30.6%

Outcome Measures

1. Primary Outcome

Title	Visual Analog Scale (VAS) for Pain
Description	A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients' pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.
Time Frame	at cystoscopic inspection of external sphincter

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tetracaine Gel Group	Dorsal Penile Nerve Block Group	Combination Group
Arm/Group Description	Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy Tetracaine: 1% Tetracaine gel instilled into urethra	Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis	Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis Tetracaine: 1% Tetracaine gel instilled into urethra
Measure Participants	86	86	86
Median (Inter-Quartile Range) [units on a scale]	6	4	4

2. Secondary Outcome

Title	Visual Analog Scale (VAS) for Pain
Description	A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients' pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.
Time Frame	before gel administration

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tetracaine Gel Group	Dorsal Penile Nerve Block Group	Combination Group
Arm/Group Description	Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy Tetracaine: 1% Tetracaine gel instilled into urethra	Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis	Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis Tetracaine: 1% Tetracaine gel instilled into urethra
Measure Participants	86	86	86
Median (Inter-Quartile Range) [units on a scale]	0	0	0

3. Secondary Outcome

Title	Visual Analog Scale (VAS) for Pain
Description	A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients' pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.
Time Frame	at cystoscopic inspection of penile and bulbar urethra

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tetracaine Gel Group	Dorsal Penile Nerve Block Group	Combination Group
Arm/Group Description	Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy Tetracaine: 1% Tetracaine gel instilled into urethra	Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis	Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis Tetracaine: 1% Tetracaine gel instilled into urethra
Measure Participants	86	86	86
Median (Inter-Quartile Range) [units on a scale]	1	1	1

4. Secondary Outcome

Title	Visual Analog Scale (VAS) for Pain
Description	A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients' pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.
Time Frame	at cystoscopic inspection of prostate and bladder

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tetracaine Gel Group	Dorsal Penile Nerve Block Group	Combination Group
Arm/Group Description	Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy Tetracaine: 1% Tetracaine gel instilled into urethra	Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis	Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis Tetracaine: 1% Tetracaine gel instilled into urethra
Measure Participants	86	86	86
Median (Inter-Quartile Range) [units on a scale]	2	0	0

5. Secondary Outcome

Title	Visual Analog Scale (VAS) for Pain
Description	A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients' pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.
Time Frame	after withdrawal of cystoscope

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tetracaine Gel Group	Dorsal Penile Nerve Block Group	Combination Group
Arm/Group Description	Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy Tetracaine: 1% Tetracaine gel instilled into urethra	Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis	Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis Tetracaine: 1% Tetracaine gel instilled into urethra
Measure Participants	86	86	86
Median (Inter-Quartile Range) [units on a scale]	0	0	0

6. Secondary Outcome

Title	Heart Rate Before Gel Administration
Time Frame	before gel administration

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tetracaine Gel Group	Dorsal Penile Nerve Block Group	Combination Group
Arm/Group Description	Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy Tetracaine: 1% Tetracaine gel instilled into urethra	Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis	Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis Tetracaine: 1% Tetracaine gel instilled into urethra
Measure Participants	86	86	86
Mean (Standard Deviation) [Beats per minute]	75.0 (9.7)	75.9 (9.4)	73.6 (10.2)

7. Secondary Outcome

Title	Heart Rate at Cystoscopic Inspection of Penile and Bulbar Urthra
Time Frame	at cystoscopic inspection of penile and bulbar urethra

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tetracaine Gel Group	Dorsal Penile Nerve Block Group	Combination Group
Arm/Group Description	Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy Tetracaine: 1% Tetracaine gel instilled into urethra	Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis	Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis Tetracaine: 1% Tetracaine gel instilled into urethra
Measure Participants	86	86	86
Mean (Standard Deviation) [Beats per minute]	84.8 (11.7)	83.8 (12.0)	81.1 (10.4)

8. Secondary Outcome

Title	Heart Rate at Cystoscopic Inspection of External Sphincter
Time Frame	at cystoscopic inspection of external sphincter

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tetracaine Gel Group	Dorsal Penile Nerve Block Group	Combination Group
Arm/Group Description	Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy Tetracaine: 1% Tetracaine gel instilled into urethra	Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis	Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis Tetracaine: 1% Tetracaine gel instilled into urethra
Measure Participants	86	86	86
Mean (Standard Deviation) [Beats per minute]	96.7 (14.1)	90.2 (14.9)	86.2 (10.9)

9. Secondary Outcome

Title	Heart Rate After Withdrawal of Cystoscope
Time Frame	after withdrawal of cystoscope

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tetracaine Gel Group	Dorsal Penile Nerve Block Group	Combination Group
Arm/Group Description	Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy Tetracaine: 1% Tetracaine gel instilled into urethra	Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis	Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis Tetracaine: 1% Tetracaine gel instilled into urethra
Measure Participants	86	86	86
Mean (Standard Deviation) [Beats per minute]	76.7 (10.9)	72.3 (10.0)	71.6 (9.2)

10. Secondary Outcome

Title	Mean Arterial Pressure Before Gel Administration
Time Frame	before gel administration

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tetracaine Gel Group	Dorsal Penile Nerve Block Group	Combination Group
Arm/Group Description	Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy Tetracaine: 1% Tetracaine gel instilled into urethra	Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis	Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis Tetracaine: 1% Tetracaine gel instilled into urethra
Measure Participants	86	86	86
Mean (Standard Deviation) [mmHg]	95.3 (10.2)	96.6 (9.7)	95.1 (9.9)

11. Secondary Outcome

Title	Mean Arterial Pressure at Cystoscopic Inspection of Penile and Bulbar Urthra
Time Frame	at cystoscopic inspection of penile and bulbar urthra

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tetracaine Gel Group	Dorsal Penile Nerve Block Group	Combination Group
Arm/Group Description	Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy Tetracaine: 1% Tetracaine gel instilled into urethra	Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis	Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis Tetracaine: 1% Tetracaine gel instilled into urethra
Measure Participants	86	86	86
Mean (Standard Deviation) [mmHg]	100 (10.6)	99.8 (10.1)	98.2 (9.0)

12. Secondary Outcome

Title	Mean Arterial Pressure at Cystoscopic Inspection of External Sphincter
Time Frame	at cystoscopic inspection of external sphincter

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tetracaine Gel Group	Dorsal Penile Nerve Block Group	Combination Group
Arm/Group Description	Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy Tetracaine: 1% Tetracaine gel instilled into urethra	Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis	Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis Tetracaine: 1% Tetracaine gel instilled into urethra
Measure Participants	86	86	86
Mean (Standard Deviation) [mmHg]	113.7 (11.7)	105.8 (10.5)	104.8 (9.2)

13. Secondary Outcome

Title	Mean Arterial Pressure After Withdrawal of Cystoscope
Time Frame	after withdrawal of cystoscope

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tetracaine Gel Group	Dorsal Penile Nerve Block Group	Combination Group
Arm/Group Description	Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy Tetracaine: 1% Tetracaine gel instilled into urethra	Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis	Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis Tetracaine: 1% Tetracaine gel instilled into urethra
Measure Participants	86	86	86
Mean (Standard Deviation) [mmHg]	99.3 (9.8)	95.7 (8.4)	95.2 (8.6)

14. Secondary Outcome

Title	Oxygen Saturation by Pulse Before Gel Administration
Time Frame	before gel administration

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tetracaine Gel Group	Dorsal Penile Nerve Block Group	Combination Group
Arm/Group Description	Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy Tetracaine: 1% Tetracaine gel instilled into urethra	Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis	Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis Tetracaine: 1% Tetracaine gel instilled into urethra
Measure Participants	86	86	86
Median (Inter-Quartile Range) [percentage]	99	98	99

15. Secondary Outcome

Title	Oxygen Saturation by Pulse at Cystoscopic Inspection of Penile and Bulbar Urthra
Time Frame	at cystoscopic inspection of penile and bulbar urthra

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tetracaine Gel Group	Dorsal Penile Nerve Block Group	Combination Group
Arm/Group Description	Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy Tetracaine: 1% Tetracaine gel instilled into urethra	Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis	Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis Tetracaine: 1% Tetracaine gel instilled into urethra
Measure Participants	86	86	86
Median (Inter-Quartile Range) [percentage]	99	98	99

16. Secondary Outcome

Title	Oxygen Saturation by Pulse at Cystoscopic Inspection of External Sphincter
Time Frame	at cystoscopic inspection of external sphincter

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tetracaine Gel Group	Dorsal Penile Nerve Block Group	Combination Group
Arm/Group Description	Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy Tetracaine: 1% Tetracaine gel instilled into urethra	Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis	Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis Tetracaine: 1% Tetracaine gel instilled into urethra
Measure Participants	86	86	86
Median (Inter-Quartile Range) [percentage]	99	98	99

17. Secondary Outcome

Title	Oxygen Saturation by Pulse After Withdrawal of Cystoscope
Time Frame	after withdrawal of cystoscope

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tetracaine Gel Group	Dorsal Penile Nerve Block Group	Combination Group
Arm/Group Description	Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy Tetracaine: 1% Tetracaine gel instilled into urethra	Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis	Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis Tetracaine: 1% Tetracaine gel instilled into urethra
Measure Participants	86	86	86
Median (Inter-Quartile Range) [percentage]	99	98	99

18. Secondary Outcome

Title	Breath Rate Before Gel Administration
Time Frame	before gel administration

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tetracaine Gel Group	Dorsal Penile Nerve Block Group	Combination Group
Arm/Group Description	Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy Tetracaine: 1% Tetracaine gel instilled into urethra	Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis	Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis Tetracaine: 1% Tetracaine gel instilled into urethra
Measure Participants	86	86	86
Mean (Standard Deviation) [times per minute]	19.8 (1.1)	19.6 (1.6)	19.5 (1.3)

19. Secondary Outcome

Title	Breath Rate at Cystoscopic Inspection of Penile and Bulbar Urthra
Time Frame	at cystoscopic inspection of penile and bulbar Urthra

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tetracaine Gel Group	Dorsal Penile Nerve Block Group	Combination Group
Arm/Group Description	Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy Tetracaine: 1% Tetracaine gel instilled into urethra	Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis	Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis Tetracaine: 1% Tetracaine gel instilled into urethra
Measure Participants	86	86	86
Mean (Standard Deviation) [times per minute]	20.0 (1.2)	19.8 (1.5)	19.6 (1.3)

20. Secondary Outcome

Title	Breath Rate at Cystoscopic Inspection of External Sphincter
Time Frame	at cystoscopic inspection of external sphincter

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tetracaine Gel Group	Dorsal Penile Nerve Block Group	Combination Group
Arm/Group Description	Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy Tetracaine: 1% Tetracaine gel instilled into urethra	Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis	Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis Tetracaine: 1% Tetracaine gel instilled into urethra
Measure Participants	86	86	86
Mean (Standard Deviation) [times per minute]	20.1 (1.3)	19.8 (1.7)	19.8 (1.5)

21. Secondary Outcome

Title	Breath Rate After Withdrawal of Cystoscope
Time Frame	after withdrawal of cystoscope

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tetracaine Gel Group	Dorsal Penile Nerve Block Group	Combination Group
Arm/Group Description	Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy Tetracaine: 1% Tetracaine gel instilled into urethra	Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis	Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis Tetracaine: 1% Tetracaine gel instilled into urethra
Measure Participants	86	86	86
Mean (Standard Deviation) [times per minute]	19.7 (1.2)	19.4 (1.5)	19.4 (1.2)

Adverse Events

Time Frame	from beginning of dorsal penile nerve block to end of cystoscopy
Arm/Group Title	Tetracaine Group		DPNB Group		Combination Group
Arm/Group Description	tetracaine gel plus DPNB with saline		DPNB with ropivacaine plus plain lubricant		DPNB with ropivacaine plus tetracaine gel
All Cause Mortality
	Tetracaine Group		DPNB Group		Combination Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Tetracaine Group		DPNB Group		Combination Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/86 (0%)		0/86 (0%)		0/86 (0%)
Other (Not Including Serious) Adverse Events
	Tetracaine Group		DPNB Group		Combination Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/86 (0%)		0/86 (0%)		0/86 (0%)

Limitations/Caveats

The VAS scale was the only main observe index, and patients could have different cognition of pain and this may affect the evaluation of pain.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.