Stohrer et al. 2007
Europe
PEDro=9
RCT
N=131

Population: Patients with neurogenic detrusor overactivity. Mean age=38.3yrs; Gender: males=99, females=32; Traumatic SCI=122, Myelitis=1, MS=2, Myelodysplasia=4, Spinal tumours=2
Treatment: To compare the efficacy and tolerability of propiverine and oxybutynin for patients with neurogenic detrusor overactivity. Patients randomized (1:1) to receive 15mg tid propiverine or 5mg tid oxybutynin for 21 days
Outcome Measures: Maximum cyctometric bladder capacity and bladder pressure.

• A sig. increase was shown in the Max cystometric capacity (mL) for both the propiverine and oxybutynin treatment groups (198 (±110) to 309 (±166) and 164 (±64) to 298 (±125) resp.)
• A sig. decrease was shown in the Max detrusor pressure during the filling phase (cm H20) for both the propiverine and oxybutynin groups (56.8 (±36.2) to 37.8 (±31.6) and (68.6 (±34.5) to 43.1 (±29.2) resp.)
• During filling cystometry, detrusor compliance showed significant improvements in both groups but no sig. inter-group differences resulted
• Residual urine for both groups was increased but the inter-group difference was not sig. (p=0.13) (propiverine (72.6ml (±115) to 140.9ml (±167) vs oxybutynin (65.3ml (±78) to 149ml (±133))
• Propiverine reported less frequent adverse events compared to oxybutynin (63.0% vs 77.8%) – Dryness of mouth was most frequently reported (47.1% vs 67.2% resp. (p=0.02)

Stohrer et al. 1999
Germany
PEDro=9
RCT
Initial N=124;
Final N=113

Population: Inpatients with detrusor overactivity and suprasacral SCI; Age = 29-30 yrs; Gender: males = 69, females = 44.
Treatment: 15mg of propiverine or placebo were given 3 times a day for 14 days
Outcome Measures: Urodynamic parameters, patients clinical symptoms, physicians assessment of efficacy, adverse events and laboratory parameters (haematology, bleeding times, clinical chemistry etc)

• Significant treatment increases:
  • Bladder capacity (p=0.006).
  • Maximal cystometric bladder capacity (p<0.0001).
  • Residual urine volume (p=0.01).
• Significant treatment decreases:
  • Maximal detrusor contractions (p<0.001).
  • Detrusor contraction duration (p<0.03).
• Improved clinical symptoms: Treatment =63.3%; placebo =22.6%.

Ethans et al. 2004 Canada
PEDro=6
RCT (Tolterodine vs placebo)
Prospective controlled trial (Oxybutynin vs tolterodine)
N=14

Population: SCI, MS; Mean Age: 40.5 yrs; Gender: males = 9, females = 1; Mean time since injury = 13.7 yrs.
Treatment: Neurogenic detrusor overactivity tx. Double-blind design with tolterodine (T) 2mg twice daily vs placebo (P). Open label: tolterodine self-selected dose (TSSD) vs oxybutynin SSD (OSSD).
Outcome Measures: Cystometric capacity, catheterization volumes, number of episodes of urinary incontinence per day, degree of mouth dryness per day using visual analog scale (VAS).

• No significant difference between T vs P groups in:
  • mean cystometric capacity
  • degree of mouth dryness
• T vs P significantly improved:
  • mean catheterization volume (263 mL vs 188 mL, p<0.001)
  • # incontinence episodes/day (1 vs 2.8, p<0.005)
• No sig. diff. btwn TSSD vs OSSD in:
  • mean cystometric capacity
  • catheterization volume
  • # incontinence episodes/day
• TSSD <OSSD for:
  • dry mouth (VAS 2.6 vs 4.4, p<0.05).

Stohrer et al. 1991 Australia
PEDro=6
RCT
N=61

Population: SCI with detrusor hyperreflexia.
Treatment: trospium chloride (20mg bid, 3wks) vs placebo.
Outcome Measures:  Pre-/post-treatment max cystometric capacity (MCC); max detrusor pressure (MDP), urinary flow rate and residual urine volumes, adverse events.

• Statistical improvements (p<0.001) in the treatment group vs placebo:
  • increased MCC
  • decreased MDP
• No effect in either group on:
  • max flow rate
  • residual urine volume
  • Side effects low and no difference between groups.

O'Leary et al. 2003
USA
Downs & Black  = 23
Pre-post
N=10

Population:  SCI: Age = 35-77 yrs; Gender: males = 2, females = 8; Severity of injury: AIS: A-D.
Treatment: Initial 10 mg of oxybutynin (extended release) daily; increased by 5mg daily until symptoms were controlled or until a max dosage of 30 mg per day.
Outcome Measures: Micturation frequency diaries and urodynamics were completed at baseline and repeated at week 12.  Tolerability info was also collected.

• Mean cystometric bladder capacity volume significantly increased (p=0.008). 
• Mean number of voids / 24 hr period decreased (p=0.003).
• Residual urine increased (p=0.02). 
• Nocturia decreased but not significant.
• Incontinence episodes / week: decreased (p=0.03)

Horstmann et al. 2006
Germany
Downs & Black =21
Prospective controlled trial
N=21

Population: Mean age = 34 yrs; Gender: males = 15, females = 6; Level of injury: paraplegia = 7, tetraplegia = 10.
Treatment: Patients were placed into one of two groups: 1) 4mg of tolterodine once a day; 2) 15mg of trospium 3 times a day. After 4 weeks, the dosage was doubled to either 4mg of tolterodine ER twice a day or 30mg of trospium three times a day.  Follow-up was monitored by a bladder diary and urodynamic evaluation.
Outcome Measures: Average reflex volume, cystometric capacity, detrusor pressure.

• The average reflex volume and cystometric capacity increased significantly (p<0.001).
• The maximum detrusor pressure dropped from 60 to 47cm H2O (p<0.05).
• Patients treated with trospium:
  • Average reflex volume increase from 177 to 314mL (p<0.05)
  • An average cystometric capacity enlargement from 271 to 430 mL (p=0.0005)
  • Maximum detrusor pressure decreased from 66 to 51 cm H2O (p<0.05).
• Patients treated with tolterodine:
• Significant increase was seen in average reflex volume (p<0.05) and bladder capacity (p<0.001).
• Average maximum detrusor pressure dropped from 54 to 43 cm H2O (p<0.05).
• One patient had to stop the medication because of intolerable side effects and five patients did not experience satisfactory benefits.

Amend et al. 2008
Germany
Downs & Black = 20
Prospective Controlled Trial
N=27

Population: SCI patients with hyperreflexia Level of injury tetraplegia=15, paraplegia=6; Mean age=35.7yrs; Gender: males=21, females=6
Treatment: Patients from a previous study continued treatment in 3 groups: Group A (n=8) received 8mg of tolterodine and oxybutynin (15-30mg); Group B (n=11) received 90mg of trospium and tolterodine (4-8mg); Group C (n=8) received 30mg of oxybutynin and trospium (45-90mg) for 4 weeks.
Outcome Measures: Incontinence events, bladder capacity, reflex volume, detrusor compliance were all measured at baseline, 4 weeks and 6 months post treatment

• No significant difference in outcomes was seen between 4 weeks and 6 month follow up.
• Number of incontinence events decreased significantly in all three groups at 4 week follow up (Group A p<0.001; Group B p<0.0005; Group C p<0.001).
• Bladder capacity decreased significantly increased at 4 week follow up in Groups A (p<0.005), B (p<0.0005), C (p<0.001).
• Reflex volume increased in all three groups post 4 week follow up (Group A p<0.005, Group B p<0.0001, Group C p<0.001).
• Detrusor compliance increased after 4 weeks of treatment in Groups A (p<0.005), B (p<0.0001), C (p<0.001)
• No significant difference was found among the treatments in detrusor compliance (p=0.97) or incontinence events (p=0.11).
• Group A had significantly lower improvement in bladder capacity compared to the other groups (p<0.002).
• Group C had significantly higher reflex volume than group B.

Kennelly et al. 2009
USA
Downs & Black = 19
Case Series
N=24

Population: SCI patients with neurogenic detrusor overactivity and incontinence. Mean age=41.9yrs; Gender: males=21, females=3; Severity of injury: AIS A=17, B=2, C=5.
Treatment: To evaluate the efficacy and safety of oxybutynin transdermal system (oxybutynin-TDS) in SCI patients with neurogenic detrusor overactivity and incontinence 8-wk dose titration period, oxybutynin-TDS doses adjusted every 2 weeks
Outcome Measures: Change in daily # of Clean Intermittent Catheterization (CIC) periods without leakage, from baseline - 8 wks or last observation using 3-day voiding diary, CIC volume and urodynamic parameters

• Baseline mean daily total CIC frequency = 5.3±1.4
• Mean daily # of CIC periods without leakage = 2.4±1.8 (all other were associated with leakage)
• During the study, overall mean daily CIC frequency (observed cases) remained constant
• Significant improvements were seen in:
  • Reflex volume (p=0.0466)
  • Maximal cystometric bladder capacity (p=0.0009)
  • Residual urine volume (p=0.0023).
  • Detrusor pressure (p=0.0457).