S0337, Gemcitabine After Surgery in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer

• Sponsor: Southwest Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00445601
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 406
• Locations: 70
• Arms: 2
• Duration (Months): 117
• Patients Per Site: 5.8
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine directly into the bladder after surgery may kill more tumor cells. It is not yet known whether giving gemcitabine directly into the bladder is more effective than a placebo in treating bladder cancer.

PURPOSE: This randomized phase III trial is studying gemcitabine to see how well it works when given directly into the bladder compared with a placebo after surgery in treating patients with newly diagnosed or recurrent bladder cancer.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer	Drug: gemcitabine hydrochloride; Other: placebo	Phase 3

Detailed Description

OBJECTIVES:

Primary

• Compare the efficacy of a single intravesical instillation of gemcitabine hydrochloride vs placebo immediately after transurethral resection of the bladder tumor (TURBT) in preventing recurrence at 2 years in patients with grade 1 or 2 superficial transitional cell cancer of the bladder.

Secondary

• Compare whether a single instillation of intravesical gemcitabine hydrochloride can improve the time to progression to muscle invasive disease vs placebo in these patients.

• Compare the qualitative and quantitative toxicities of these regimens in these patients.

• Compare whether treatment with post-TURBT intravesical instillation of gemcitabine vs placebo results in reduced long-term morbidity in patients, as defined by requirement for fewer TURBTs, courses of traditional intravesical therapies, and surveillance cystoscopies over 4 years.

Tertiary

• Assess whether performing a combination of molecular and/or cytologic diagnostic marker tests, including NMP-22 Bladder Chek and BTA Stat every 3 months, can predict recurrence as accurately as cystoscopy alone in these patients.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to disease status (first occurrence vs recurrent disease) and number of tumor sites (1 vs ≥ 2). Patients are randomized to 1 of 2 treatment arms.

All patients undergo transurethral resection of the bladder tumor. Within 3 hours, patients receive intravesical therapy according to their randomized arm.

• Arm I: Patients receive intravesical gemcitabine hydrochloride over 1 hour.

• Arm II: Patients receive intravesical placebo over 1 hour. Urine is collected at baseline and then every 3 months for 2 years for research studies including the NMP-22 Bladder Chek and BTA Stat test.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 340 patients will be accrued for this study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 406 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase III Blinded Study of Immediate Post TURBT Instillation of Gemcitabine Versus Saline in Patients With Newly Diagnosed or Occasionally Recurring Grade I/II Superficial Bladder Cancer
• Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: Jun 1, 2017
• Actual Study Completion Date: Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I Patients receive intravesical gemcitabine hydrochloride over 1 hour.	Drug: gemcitabine hydrochloride; Given intravesically
Placebo Comparator: Arm II Patients receive intravesical placebo over 1 hour.	Other: placebo; Given intravesically

Outcome Measures

Primary Outcome Measures

1. Disease Recurrence Rate [Up to 2 Years]

   Percentage of patients who experienced a recurrence of grade 1 or 2 superficial transitional cell cancer of the bladder between the date of registration and 24 months. Disease recurrence considered to occur at date of first observation of recurrent disease subsequently confirmed by biopsy. Patients without recurrence were censored at the time of their last cystoscopy.

Secondary Outcome Measures

1. Rate of Progression to Muscle Invasive Disease at 4 Years [4 years]

   From date of registration to date of diagnosis of progressive disease. Censor at date of last disease assessment for those without progression.

2. Compare Qualitative and Quantitative Toxicities Between the Treatment Arms [Up to 4 years after Transurethral Resection of Bladder Tumor (TURBT)]

   Number of patients with Grade 3 through Grade 5 adverse events that are related to study drug

3. Rate of Disease Worsening Over 2 Years [Up to 2 years]

   Compare whether treatment with post-TURBT intravesical instillation of gemcitabine vs placebo results in reduced long-term morbidity in patients, as defined by requirement for fewer TURBTs, courses of traditional intravesical therapies, and surveillance cystoscopies over 4 years.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Diagnosis of newly diagnosed or recurrent transitional cell bladder cancer meeting the following criteria:

• Ta or T1 primary tumor

• Grade 1 or 2 disease

• No more than 2 recurrences (except for index tumor) within the 18 months prior to the index tumor's transurethral resection of the bladder tumor (TURBT)

• Index tumor post-TURBT must meet the following criteria:

• Ta or T1 tumor without any prior tumor in situ, grade 3 (high grade) disease within 2 years prior to index tumor TURBT, or invasion of the muscularis propria (stage ≥ T2)

• Grade 1 or 2 disease (similar to papillary urothelial neoplasm of low malignant potential and low-grade bladder cancer)

• Not a candidate for a therapy other than TURBT (e.g., a series of instillations of intravesical immunotherapy [e.g., BCG] or intravesical chemotherapy, or cystectomy or partial cystectomy)

• Negative upper tract imaging studies within 1 year (365 days) prior to study entry

• Imaging studies may be performed after registration provided it is done prior to TURBT on the day of treatment

• No urothelial cancer of the prostate or more distal urethra (or urethra at all in women) as assessed by endoscopy

• Must have a negative urine culture (less than or equal to 10,000 col/mL, mixed flora-likely contamination) OR negative urine analysis for infection AND negative nitrates on reagent strip, ≤ 10 white blood cell count (WBC)/high-power field, and no rods or organisms on examination of spun urine sediment OR an automated or visual reagent strip urinalysis that is negative for leukocytes and nitrates within the past 28 days

• TURBT planned within the next 28 days and planned treatment within 3 hours after TURBT

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-1

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other prior malignancy except for any of the following:

• Adequately treated basal cell or squamous cell skin cancer

• In situ cervical cancer

• Adequately treated stage I or II cancer from which patient is in complete remission

• Any other cancer from which patient has been disease-free for 3 years

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• More than 145 days since prior intravesical therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
2	Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
3	University of California Davis Cancer Center	Sacramento	California	United States	95817
4	University of Colorado Cancer Center at UC Health Sciences Center	Aurora	Colorado	United States	80045
5	Urology Center of Colorado	Denver	Colorado	United States	80211
6	Veterans Affairs Medical Center - Denver	Denver	Colorado	United States	80220
7	St. Joseph Regional Medical Center	Lewiston	Idaho	United States	83501
8	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois	United States	60153
9	St. Rose Ambulatory and Surgery Center	Great Bend	Kansas	United States	67530
10	Hays Medical Center	Hays	Kansas	United States	67601
11	Hutchinson Hospital Corporation	Hutchinson	Kansas	United States	67502
12	Kansas City Cancer Centers - West	Kansas City	Kansas	United States	66112
13	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Kansas City	Kansas	United States	66160-7357
14	Kansas City Cancer Centers - Southwest	Overland Park	Kansas	United States	66210
15	Mount Carmel Regional Cancer Center	Pittsburg	Kansas	United States	66762
16	Tammy Walker Cancer Center at Salina Regional Health Center	Salina	Kansas	United States	67401
17	Kansas City Cancer Center - Shawnee Mission	Shawnee Mission	Kansas	United States	66204
18	St. Francis Comprehensive Cancer Center	Topeka	Kansas	United States	66606
19	Feist-Weiller Cancer Center at Louisiana State University Health Sciences	Shreveport	Louisiana	United States	71130-3932
20	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109-0942
21	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan	United States	48202
22	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan	United States	48073
23	Truman Medical Center - Hospital Hill	Kansas City	Missouri	United States	64108
24	Veterans Affairs Medical Center - Kansas City	Kansas City	Missouri	United States	64128
25	Kansas City Cancer Centers - South	Kansas City	Missouri	United States	64131
26	Kansas City Cancer Centers - North	Kansas City	Missouri	United States	64154
27	Kansas City Cancer Centers - East	Lee's Summit	Missouri	United States	64064
28	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
29	St. Vincent Healthcare Cancer Care Services	Billings	Montana	United States	59101
30	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana	United States	59102
31	Billings Clinic - Downtown	Billings	Montana	United States	59107-7000
32	Bozeman Deaconess Cancer Center	Bozeman	Montana	United States	59715
33	St. James Healthcare Cancer Care	Butte	Montana	United States	59701
34	Great Falls Clinic - Main Facility	Great Falls	Montana	United States	59405
35	Sletten Cancer Institute at Benefis Healthcare	Great Falls	Montana	United States	59405
36	Northern Montana Hospital	Havre	Montana	United States	59501
37	St. Peter's Hospital	Helena	Montana	United States	59601
38	Glacier Oncology, PLLC	Kalispell	Montana	United States	59901
39	Kalispell Medical Oncology at KRMC	Kalispell	Montana	United States	59901
40	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
41	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana	United States	59807-7877
42	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59807
43	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York	United States	14642
44	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina	United States	28232-2861
45	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
46	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma	United States	73104
47	Bay Area Hospital	Coos Bay	Oregon	United States	97420
48	Knight Cancer Institute at Oregon Health and Science University	Portland	Oregon	United States	97239-3098
49	Brooke Army Medical Center	Fort Sam Houston	Texas	United States	78234-6200
50	M. D. Anderson Cancer Center at University of Texas	Houston	Texas	United States	77030-4009
51	Baylor University Medical Center - Houston	Houston	Texas	United States	77030
52	Methodist Hospital	Houston	Texas	United States	77030
53	Veterans Affairs Medical Center - Houston	Houston	Texas	United States	77030
54	Wilford Hall Medical Center	Lackland Air Force Base	Texas	United States	78236
55	Veterans Affairs Medical Center - San Antonio (Murphy)	San Antonio	Texas	United States	78209
56	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229-3900
57	Cancer Therapy and Research Center	San Antonio	Texas	United States	78229
58	University Hospital - San Antonio	San Antonio	Texas	United States	78229
59	Overlake Cancer Center at Overlake Hospital Medical Center	Bellevue	Washington	United States	98004
60	Providence Centralia Hospital	Centralia	Washington	United States	98531-9027
61	Providence Regional Cancer Partnership	Everett	Washington	United States	98201
62	St. Francis Hospital	Federal Way	Washington	United States	98003
63	Providence St. Peter Hospital Regional Cancer Center	Olympia	Washington	United States	98506-5166
64	Good Samaritan Cancer Center	Puyallup	Washington	United States	98372
65	Franciscan Cancer Center at St. Joseph Medical Center	Tacoma	Washington	United States	98405-3004
66	Allenmore Hospital	Tacoma	Washington	United States	98405
67	CCOP - Northwest	Tacoma	Washington	United States	98405
68	MultiCare Regional Cancer Center at Tacoma General Hospital	Tacoma	Washington	United States	98405
69	Madigan Army Medical Center - Tacoma	Tacoma	Washington	United States	98431
70	St. Clare Hospital	Tacoma	Washington	United States	98499

Sponsors and Collaborators

• Southwest Oncology Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: Edward M. Messing, MD, FACS, James P. Wilmot Cancer Center
• Study Chair: Deepak M. Sahasrabudhe, MD, James P. Wilmot Cancer Center
• Study Chair: Theresa M. Koppie, MD, Oregon Health and Science University
• Study Chair: David P. Wood, MD, Beaumont Physician Partners

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Oct 29, 2013

More Information

Additional Information:

• Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive

Publications

None provided.

• Responsible Party: Southwest Oncology Group
• ClinicalTrials.gov Identifier: NCT00445601
• Other Study ID Numbers: CDR0000534235; S0337; U10CA032102
• First Posted: Mar 9, 2007
• Last Update Posted: Jan 18, 2020
• Last Verified: Jan 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Southwest Oncology Group: transitional cell carcinoma of the bladder; stage 0 bladder cancer; stage I bladder cancer; recurrent bladder cancer
• Additional relevant MeSH terms: Urinary Bladder Neoplasms; Gemcitabine

Study Results

Participant Flow

Arm/Group Title	Arm I	Arm II
Arm/Group Description	Patients receive intravesical gemcitabine hydrochloride over 1 hour post-TURBT. gemcitabine hydrochloride: Given intravesically	Patients receive intravesical placebo over 1 hour post-TURBT. placebo: Given intravesically
Period Title: Overall Study
STARTED	201	205
Received TURBT	190	193
COMPLETED	168	177
NOT COMPLETED	33	28

Baseline Characteristics

Arm/Group Title	Arm I	Arm II	Total
Arm/Group Description	Patients receive intravesical gemcitabine hydrochloride over 1 hour post-TURBT. gemcitabine hydrochloride: Given intravesically	Patients receive intravesical placebo over 1 hour post-TURBT. placebo: Given intravesically	Total of all reporting groups
Overall Participants	201	205	406
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	66	66	66
Sex: Female, Male (Count of Participants)
Female	38 18.9%	24 11.7%	62 15.3%
Male	163 81.1%	181 88.3%	344 84.7%
Race/Ethnicity, Customized (Count of Participants)
White	186 92.5%	185 90.2%	371 91.4%
Black	6 3%	9 4.4%	15 3.7%
Asian	4 2%	5 2.4%	9 2.2%
Native American	0 0%	2 1%	2 0.5%
Unknown	5 2.5%	4 2%	9 2.2%
Occurence status (Count of Participants)
First Occurence	128 63.7%	128 62.4%	256 63.1%
Recurrent	66 32.8%	77 37.6%	143 35.2%
Unknown	7 3.5%	0 0%	7 1.7%
Number of tumors (Count of Participants)
1	135 67.2%	140 68.3%	275 67.7%
>= 2	66 32.8%	65 31.7%	131 32.3%
Prior intravesical therapy (Count of Participants)
Yes	39 19.4%	39 19%	78 19.2%
No	162 80.6%	166 81%	328 80.8%
Zubrod Performance Status (Count of Participants)
0	157 78.1%	165 80.5%	322 79.3%
1	44 21.9%	40 19.5%	84 20.7%
Smoking history (Count of Participants)
Current	49 24.4%	54 26.3%	103 25.4%
Prior	98 48.8%	101 49.3%	199 49%
Never	54 26.9%	46 22.4%	100 24.6%
Unknown	0 0%	4 2%	4 1%

Outcome Measures

1. Primary Outcome

Title	Disease Recurrence Rate
Description	Percentage of patients who experienced a recurrence of grade 1 or 2 superficial transitional cell cancer of the bladder between the date of registration and 24 months. Disease recurrence considered to occur at date of first observation of recurrent disease subsequently confirmed by biopsy. Patients without recurrence were censored at the time of their last cystoscopy.
Time Frame	Up to 2 Years

Outcome Measure Data

Analysis Population Description

Intent-to-Treat population

Arm/Group Title	Arm I	Arm II
Arm/Group Description	Patients receive intravesical gemcitabine hydrochloride over 1 hour. gemcitabine hydrochloride: Given intravesically	Patients receive intravesical placebo over 1 hour. placebo: Given intravesically
Measure Participants	201	205
Number [percentage of patients with recurrence]	27.86	40

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I, Arm II
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.66
	Confidence Interval	(2-Sided) 95%; 0.48 to 0.90
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Rate of Progression to Muscle Invasive Disease at 4 Years
Description	From date of registration to date of diagnosis of progressive disease. Censor at date of last disease assessment for those without progression.
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Population

Arm/Group Title	Arm I	Arm II
Arm/Group Description	Patients receive intravesical gemcitabine hydrochloride over 1 hour post-TURBT. gemcitabine hydrochloride: Given intravesically	Patients receive intravesical placebo over 1 hour post-TURBT. placebo: Given intravesically
Measure Participants	201	205
Number [percentage of patients with progression]	2.49	4.39

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I, Arm II
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.23
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.51
	Confidence Interval	(2-Sided) 95%; 0.18 to 1.49
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Compare Qualitative and Quantitative Toxicities Between the Treatment Arms
Description	Number of patients with Grade 3 through Grade 5 adverse events that are related to study drug
Time Frame	Up to 4 years after Transurethral Resection of Bladder Tumor (TURBT)

Outcome Measure Data

Analysis Population Description

All eligible patients who received instillation after TURBT and reported adverse events

Arm/Group Title	Arm I: Gemcitabine	Arm II: Placebo
Arm/Group Description	Patients receive intravesical gemcitabine hydrochloride over 1 hour post-TURBT.	Patients receive intravesical placebo over 1 hour post -TURBT.
Measure Participants	165	174
Bladder spasms	0 0%	1 0.5%
Hemorrhage, GU - Bladder	1 0.5%	0 0%
Hemorrhage, GU - Urinary NOS	2 1%	1 0.5%
Infection-Other (Specify)	1 0.5%	0 0%
Pain - Bladder	0 0%	1 0.5%
Pain - Urethra	0 0%	1 0.5%
Urinary frequency/urgency	0 0%	2 1%

4. Secondary Outcome

Title	Rate of Disease Worsening Over 2 Years
Description	Compare whether treatment with post-TURBT intravesical instillation of gemcitabine vs placebo results in reduced long-term morbidity in patients, as defined by requirement for fewer TURBTs, courses of traditional intravesical therapies, and surveillance cystoscopies over 4 years.
Time Frame	Up to 2 years

Outcome Measure Data

Analysis Population Description

TURBT data after patients stopped trial was not collected.

Arm/Group Title	Arm I: Gemcitabine	Arm II: Placebo
Arm/Group Description	Patients receive intravesical gemcitabine hydrochloride over 1 hour post-TURBT.	Patients receive intravesical placebo over 1 hour post -TURBT.
Measure Participants	0	0

Adverse Events

Time Frame	Assessed every 3 months for 2 years, then every 6 months for 2 years
Adverse Event Reporting Description	Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).
Arm/Group Title	Arm I: Gemcitabine		Arm II: Placebo
Arm/Group Description	Patients receive intravesical gemcitabine hydrochloride over 1 hour post-TURBT.		Patients receive intravesical placebo over 1 hour post-TURBT.
All Cause Mortality
	Arm I: Gemcitabine		Arm II: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/201 (8.5%)		25/205 (12.2%)
Serious Adverse Events
	Arm I: Gemcitabine		Arm II: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/165 (4.2%)		5/174 (2.9%)
Cardiac disorders
Cardiac General-Other	1/165 (0.6%)		0/174 (0%)
Infections and infestations
Infection with unknown ANC - Blood	0/165 (0%)		1/174 (0.6%)
Infection with unknown ANC - Urinary tract NOS	0/165 (0%)		1/174 (0.6%)
Infection-Other	1/165 (0.6%)		0/174 (0%)
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)	1/165 (0.6%)		0/174 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor flare	0/165 (0%)		1/174 (0.6%)
Nervous system disorders
CNS cerebrovascular ischemia	1/165 (0.6%)		0/174 (0%)
Vasovagal episode	1/165 (0.6%)		0/174 (0%)
Renal and urinary disorders
Hemorrhage, GU - Bladder	2/165 (1.2%)		0/174 (0%)
Hemorrhage, GU - Urinary NOS	0/165 (0%)		1/174 (0.6%)
Obstruction, GU - Bladder	0/165 (0%)		1/174 (0.6%)
Obstruction, GU - Ureter	1/165 (0.6%)		0/174 (0%)
Pain - Bladder	1/165 (0.6%)		0/174 (0%)
Renal failure	1/165 (0.6%)		0/174 (0%)
Other (Not Including Serious) Adverse Events
	Arm I: Gemcitabine		Arm II: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	60/165 (36.4%)		58/174 (33.3%)
Gastrointestinal disorders
Nausea	11/165 (6.7%)		3/174 (1.7%)
Vomiting	9/165 (5.5%)		1/174 (0.6%)
Renal and urinary disorders
Bladder spasms	13/165 (7.9%)		9/174 (5.2%)
Hemorrhage, GU - Urinary NOS	16/165 (9.7%)		19/174 (10.9%)
Pain - Bladder	23/165 (13.9%)		23/174 (13.2%)
Urinary frequency/urgency	25/165 (15.2%)		25/174 (14.4%)
Urinary retention (including neurogenic bladder)	9/165 (5.5%)		10/174 (5.7%)

Limitations/Caveats

[Not Specified]

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.