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Completed

NCT Number: NCT00831701

Medical Expulsive Therapy of Single Distal Ureteral Stones

Current therapeutic options for ureteral stones include active intervention as well as conservative "watch and wait" approaches. Endoscopic treatment of ureteral stones has a high success rate and reliably results in immediate stone removal However, surgical as well as anaesthetic risks are not negligible and serious complications are possible. For many patients, a conservative treatment is an appealing option. Watchful waiting, however, not always results in stone clearance and may be associated with recurrent renal colics.

The therapeutic potential of alpha-blockers for ureteral stone disease has been investigated prompted by the detection of alpha-receptors in ureteral smooth muscle cells. Blocking of such receptors, which are predominantly located in the distal part of the ureter results in relaxation of the ureteral wall and modulation of peristaltic activity. This mechanism has been proposed to facilitate stone passage for ureteral calculi.

Numerous clinical trials have revealed a significant improvement of the stone expulsion rate using the alpha-blocker tamsulosin. Most of these studies were randomised but none were performed in a double-blind and placebo-controlled fashion. Therefore, the objective of this trial was to evaluate the efficacy of medical expulsive therapy with tamsulosin in a randomised, double-blind, placebo-controlled setting.

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Key information

Conditions

Ureteral Calculi Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Ureteral Diseases Ureterolithiasis Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology, University Hospital Zürich, Switzerland

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with a single 2 to 7mm ureteral stone below the common iliac vessels

Exclusion criteria

  • presence of multiple ureteral stones
  • renal insufficiency (glomerular filtration rate below 60 ml/min)
  • urinary tract infection
  • a solitary kidney
  • pregnancy
  • history of ureteral surgery or previous endoscopic procedure
  • hypersensitivity to tamsulosin
  • current alpha-blocker, calcium-antagonist or corticosteroid medication

Treatment and study plan

Tamsulosin

Drug

0.4 mg Tamsulosin once daily for 21 days

Other names: Pradif, Flomax

Placebo

Drug

One placebo pill per day for 21 days or until stone expulsion

Primary outcomes

  1. Number of Participants With Stone Expulsion

    Time frame: 21 days

    The primary end point was the number of patients per group experiencing stone expulsion until day 21, as confirmed by low-dose abdominal computed tomography (CT).

Secondary outcomes

  1. Time to Stone Passage

    Time frame: 21 days

    The patient-defined time of stone expulsion was considered the event for time to stone passage. Patients with unnoticed stone expulsion were censored at the date of last positive stone status, and those who discontinued the therapy were censored at the date of last medication intake. Kaplan-Meier estimates were computed for time to stone passage.

  2. Required Analgesics

    Time frame: Until stone expulsion or up to 21 days

    Oral diclophenac (up to 3x50 mg pills) as first-line and oral metamizole (up to 8x 500mg pills)as second-line on-demand analgesics were prescribed. All patients were requested to record the required amount of pills per day

  3. Maximum Daily Pain Score

    Time frame: Until stone expulsion or up to 21 days

    All patients kept a diary to record the score of every painful episode on a 10-cm visual analogue scale (0= no pain at all; 10= strongest pain one can imagine).

  4. Number of Participants Requiring Active Treatment

    Time frame: 21 days

    The number of participants requiring active treatment was recorded. Shock wave lithotrypsy (SWL), ureterorenoscopy (URS) or insertion of an ureteral catheter were considered as active treatment.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Medical Expulsive Therapy of Single Distal Ureteral Stones. A Randomised, Double-blind and Placebo-controlled Study

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 29, 2009
Registry last updated
May 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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