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Desmopressin for Improving Nocturnal Enuresis in Patients After Radical Cystectomy With Bladder Reconstruction

Clalit Health Services logo

Clalit Health Services

Status and phase

Unknown
Phase 4

Conditions

Nocturnal Enuresis

Treatments

Drug: Desmopressin

Study type

Interventional

Funder types

Other

Identifiers

NCT01582542
0366-11-RMC

Details and patient eligibility

About

The purpose of this study is to prospectively assess whether Desmopressin, given for a period of month to patients after radical cystectomy with orthotopic bladder reconstruction, improves and lowers the rate of nocturnal enuresis.

Full description

We will prospectively assess the utilization of Desmopressin in improving nocturnal enuresis in patients after radical cystectomy with orthotopic bladder reconstruction.

Patients after radical cystectomy with neobladder reconstruction will be given Desmopressin 0.1 mg once a day for a duration of one month.

Before beginning treatment patients will be given the NNES-Q questionnaire to assess severity of nocturnal enuresis.

At the end of treatment, the same questionnaire will be given to all patients to assess if nocturnal enuresis improved.

Sodium levels will be tested before treatment, 2 weeks after beginning treatment and at the end of treatment.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age above 18
  • Able to give informed consent
  • Patients afte radical cystectomy with orthotopic bladder reconstruction with night time incontinence

Exclusion criteria

  • Patients with after radical cystectomy with orthotopic bladder reconstruction with daytime urinary incontinence
  • Patients already treated with Desmopressin due to other reasons.
  • Patients with an allergy or insensitivity to Desmopressin.
  • Patients with known hyponatremia
  • Patients with severe chronic renal failure and creatinine clearance of below 50 cc/sec.
  • Patients with severe congestive heart failure
  • Patients with active urinary tract infection
  • Patients taking drug therapy which can interact with Desmopressin and affect it's action.Examples include Diuretics, Tricyclic antidepressants, Carbamezapine and Chlorpropamide AND Indomethacin.
  • Patients with an indwelling urinary catheter.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Desmopressin
Experimental group
Treatment:
Drug: Desmopressin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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